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. 2021 Mar 9;3(3):CD007478.
doi: 10.1002/14651858.CD007478.pub2.

Interventions for cutaneous disease in systemic lupus erythematosus

Cora W Hannon  1 , Collette McCourt  2 , Hermenio C Lima  3 , Suephy Chen  4 , Cathy Bennett  5
Affiliations

Interventions for cutaneous disease in systemic lupus erythematosus

Cora W Hannon et al. Cochrane Database Syst Rev. .

Abstract

Background: Lupus erythematosus is an autoimmune disease with significant morbidity and mortality. Cutaneous disease in systemic lupus erythematosus (SLE) is common. Many interventions are used to treat SLE with varying efficacy, risks, and benefits.

Objectives: To assess the effects of interventions for cutaneous disease in SLE.

Search methods: We searched the following databases up to June 2019: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, Wiley Interscience Online Library, and Biblioteca Virtual em Saude (Virtual Health Library). We updated our search in September 2020, but these results have not yet been fully incorporated.

Selection criteria: We included randomised controlled trials (RCTs) of interventions for cutaneous disease in SLE compared with placebo, another intervention, no treatment, or different doses of the same intervention. We did not evaluate trials of cutaneous lupus in people without a diagnosis of SLE.

Data collection and analysis: We used standard methodological procedures expected by Cochrane. Primary outcomes were complete and partial clinical response. Secondary outcomes included reduction (or change) in number of clinical flares; and severe and minor adverse events. We used GRADE to assess the quality of evidence.

Main results: Sixty-one RCTs, involving 11,232 participants, reported 43 different interventions. Trials predominantly included women from outpatient clinics; the mean age range of participants was 20 to 40 years. Twenty-five studies reported baseline severity, and 22 studies included participants with moderate to severe cutaneous lupus erythematosus (CLE); duration of CLE was not well reported. Studies were conducted mainly in multi-centre settings. Most often treatment duration was 12 months. Risk of bias was highest for the domain of reporting bias, followed by performance/detection bias. We identified too few studies for meta-analysis for most comparisons. We limited this abstract to main comparisons (all administered orally) and outcomes. We did not identify clinical trials of other commonly used treatments, such as topical corticosteroids, that reported complete or partial clinical response or numbers of clinical flares. Complete clinical response Studies comparing oral hydroxychloroquine against placebo did not report complete clinical response. Chloroquine may increase complete clinical response at 12 months' follow-up compared with placebo (absence of skin lesions) (risk ratio (RR) 1.57, 95% confidence interval (CI) 0.95 to 2.61; 1 study, 24 participants; low-quality evidence). There may be little to no difference between methotrexate and chloroquine in complete clinical response (skin rash resolution) at 6 months' follow-up (RR 1.13, 95% CI 0.84 to 1.50; 1 study, 25 participants; low-quality evidence). Methotrexate may be superior to placebo with regard to complete clinical response (absence of malar/discoid rash) at 6 months' follow-up (RR 3.57, 95% CI 1.63 to 7.84; 1 study, 41 participants; low-quality evidence). At 12 months' follow-up, there may be little to no difference between azathioprine and ciclosporin in complete clinical response (malar rash resolution) (RR 0.83, 95% CI 0.46 to 1.52; 1 study, 89 participants; low-quality evidence). Partial clinical response Partial clinical response was reported for only one key comparison: hydroxychloroquine may increase partial clinical response at 12 months compared to placebo, but the 95% CI indicates that hydroxychloroquine may make no difference or may decrease response (RR 7.00, 95% CI 0.41 to 120.16; 20 pregnant participants, 1 trial; low-quality evidence). Clinical flares Clinical flares were reported for only two key comparisons: hydroxychloroquine is probably superior to placebo at 6 months' follow-up for reducing clinical flares (RR 0.49, 95% CI 0.28 to 0.89; 1 study, 47 participants; moderate-quality evidence). At 12 months' follow-up, there may be no difference between methotrexate and placebo, but the 95% CI indicates there may be more or fewer flares with methotrexate (RR 0.77, 95% CI 0.32 to 1.83; 1 study, 86 participants; moderate-quality evidence). Adverse events Data for adverse events were limited and were inconsistently reported, but hydroxychloroquine, chloroquine, and methotrexate have well-documented adverse effects including gastrointestinal symptoms, liver problems, and retinopathy for hydroxychloroquine and chloroquine and teratogenicity during pregnancy for methotrexate.

Authors' conclusions: Evidence supports the commonly-used treatment hydroxychloroquine, and there is also evidence supporting chloroquine and methotrexate for treating cutaneous disease in SLE. Evidence is limited due to the small number of studies reporting key outcomes. Evidence for most key outcomes was low or moderate quality, meaning findings should be interpreted with caution. Head-to-head intervention trials designed to detect differences in efficacy between treatments for specific CLE subtypes are needed. Thirteen further trials are awaiting classification and have not yet been incorporated in this review; they may alter the review conclusions.

Trial registration: ClinicalTrials.gov NCT01597050 NCT02953821 NCT01162681 NCT01438489 NCT01753401 NCT01283139 NCT00299819 NCT01205438 NCT02265744 NCT01112215 NCT01484496 NCT01802740 NCT02349061 NCT00071487 NCT00111306 NCT00383214 NCT00624351 NCT00660881 NCT02708095 NCT02185040 NCT01551069 NCT00775476 NCT02074020 NCT02514967 NCT02711813 NCT02975336 NCT01449071 NCT01649765 NCT02465580 NCT02932137 NCT02665364 NCT02437890 NCT02446899 NCT02446912 NCT02554019 NCT02847598 NCT03958955 NCT01345253 NCT01781611 NCT02270957 NCT02660944 NCT02822989 NCT03161483 NCT03252587 NCT03451422 NCT03517722 NCT03616912 NCT03616964 NCT03845517 NCT03978520 NCT04058028 NCT04060888 NCT03312907.

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Conflict of interest statement

Cora W Hannon: has declared that they have no conflict of interest. Collette McCourt: reports consultancy fees from Janssen Pharmaceuticals (paid as a panel member to consult on a medical education steering committee (no relation to SLE/cutaneous lupus or medication); Janssen manufacture STELARA, which is in phase 3 trials for SLE); personal payment. CM reports personal payment to prepare and deliver a lecture on biologic drugs in psoriasis from Janssen Pharmaceuticals. CM reports personal payment from AbbVie (virtual meeting sponsorship for American Academy of Dermatology (AAD) 2020, and meeting travel, accommodation, and attendance for AAD Florida 2017); Janssen Pharmaceuticals (meeting travel, accommodation, and attendance for European Academy of Dermatology and Venereology (EADV) Madrid 2019, AAD Washington 2019, and AAD San Diego 2018); and Celgene (meeting travel, accommodation, and attendance for EADV Paris 2018). CM is currently a co‐author of the British Association of Dermatologists Guideline Group for Cutaneous Lupus Erythematosus (from 2016 to present). This is not financially reimbursed. CM has received financial support for travel, accommodation, and conference attendance by Almirall and UCB; she has received consultancy and guest speaker honorarium from AbbVie and Janssen Pharmaceuticals. She reports that none of these are directly relevant to her role as co‐author of this Cochrane Review. Hermenio C Lima: reports consultancy fees from AbbVie (Abbott), Amgen, AstraZeneca, Bristol‐Myers Squibb, Celgene, Dermira, Eli Lilly, Janssen, La Roche‐Posay, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, and Sanofi; personal payment. HL reports grants/grants pending for clinical trials from AbbVie (Abbott), Amgen, AstraZeneca, Bristol‐Myers Squibb, Celgene, Dermira, Eli Lilly, Janssen, La Roche‐Posay, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, and Sanofi; personal payment. HL reports payment for lectures from AbbVie, Novartis, Sanofi, and Bausch Health; personal payment. HL reports payment for development of educational presentations from AbbVie (Abbott), Celgene, Janssen, Leo Pharmaceutics, Novartis, Sanofi, and Pediapharma. “I, Hermenio Lima, have received grants, speaker honorarium, consulting fees, and/or advisory boards from the companies listed above. None of these were related to this review or its subject.” Suephy Chen: has declared that they have no conflict of interest. Cathy Bennett: reports consultancy fees paid to her own company, Systematic Research Ltd. "I am the proprietor of Systematic Research Ltd. My company received a consultancy fee to enable me to work as a co‐author of this review. This included drafting text, extracting data, screening searches, co‐ordinating work and producing reports and summaries. Since I am the sole employee of Systematic Research Ltd, the consultancy fees from this and other work are paid to me in the form of a salary and company dividends. I have business relationships with other clients who may provide consultancy fees for evidence‐based medicine reviews, projects, and reports."

Figures

1
1
Study flow diagram: PRISMA diagram showing the screening process.
2
2
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Oral methotrexate versus placebo, Outcome 1: Primary outcome (lupus‐specific): absence of malar or discoid rash
1.2
1.2. Analysis
Comparison 1: Oral methotrexate versus placebo, Outcome 2: Secondary outcome (lupus‐specific): severe clinical flare (requiring discontinuation of study)
1.3
1.3. Analysis
Comparison 1: Oral methotrexate versus placebo, Outcome 3: Adverse events
2.1
2.1. Analysis
Comparison 2: Oral hydroxychloroquine versus placebo, Outcome 1: Primary outcome (lupus‐specific): partial improvement in skin lesions during pregnancy
2.2
2.2. Analysis
Comparison 2: Oral hydroxychloroquine versus placebo, Outcome 2: Secondary outcome (lupus‐specific): clinical flare in skin disease
2.3
2.3. Analysis
Comparison 2: Oral hydroxychloroquine versus placebo, Outcome 3: Secondary outcome (lupus‐non‐specific): vasculitis
2.4
2.4. Analysis
Comparison 2: Oral hydroxychloroquine versus placebo, Outcome 4: Secondary outcome (lupus‐non‐specific): major flare in lupus (vasculitis, skin or other system)
2.5
2.5. Analysis
Comparison 2: Oral hydroxychloroquine versus placebo, Outcome 5: Secondary outcome (lupus‐specific): systemic lupus flare during pregnancy study
2.6
2.6. Analysis
Comparison 2: Oral hydroxychloroquine versus placebo, Outcome 6: Adverse events: severe ‐ toxaemia during pregnancy study
2.7
2.7. Analysis
Comparison 2: Oral hydroxychloroquine versus placebo, Outcome 7: Adverse events: severe ‐ adverse event related to medication
2.8
2.8. Analysis
Comparison 2: Oral hydroxychloroquine versus placebo, Outcome 8: Adverse events: severe ‐ any severe event
2.9
2.9. Analysis
Comparison 2: Oral hydroxychloroquine versus placebo, Outcome 9: Adverse events: severe ‐ rash
2.10
2.10. Analysis
Comparison 2: Oral hydroxychloroquine versus placebo, Outcome 10: Adverse events: severe ‐ worsening symptoms leading to study withdrawal (lack of treatment efficacy)
2.11
2.11. Analysis
Comparison 2: Oral hydroxychloroquine versus placebo, Outcome 11: Adverse events: severe ‐ sudden death ‐ not thought to be related to medication
2.12
2.12. Analysis
Comparison 2: Oral hydroxychloroquine versus placebo, Outcome 12: Adverse events: minor
3.1
3.1. Analysis
Comparison 3: Oral dehydroepiandrosterone versus placebo, Outcome 1: Primary outcome (lupus‐specific): absence of oral stomatitis
3.2
3.2. Analysis
Comparison 3: Oral dehydroepiandrosterone versus placebo, Outcome 2: Primary outcome (lupus‐specific): absence of cutaneous rash
3.3
3.3. Analysis
Comparison 3: Oral dehydroepiandrosterone versus placebo, Outcome 3: Primary outcome (lupus‐non‐specific): absence of alopecia
3.4
3.4. Analysis
Comparison 3: Oral dehydroepiandrosterone versus placebo, Outcome 4: Adverse events: severe ‐ any
3.5
3.5. Analysis
Comparison 3: Oral dehydroepiandrosterone versus placebo, Outcome 5: Adverse events: severe ‐ death
3.6
3.6. Analysis
Comparison 3: Oral dehydroepiandrosterone versus placebo, Outcome 6: Adverse events: severe ‐ cancer diagnosis
3.7
3.7. Analysis
Comparison 3: Oral dehydroepiandrosterone versus placebo, Outcome 7: Adverse events: minor ‐ presence of acne
3.8
3.8. Analysis
Comparison 3: Oral dehydroepiandrosterone versus placebo, Outcome 8: Adverse events: minor ‐ presence of hirsutism
3.9
3.9. Analysis
Comparison 3: Oral dehydroepiandrosterone versus placebo, Outcome 9: Adverse events: minor ‐ presence of rash
4.1
4.1. Analysis
Comparison 4: Intravenous belimumab (1.0, 4.0, 10.0 mg/kg) versus placebo, Outcome 1: Adverse events: severe at belimumab 1 mg/kg dose
4.2
4.2. Analysis
Comparison 4: Intravenous belimumab (1.0, 4.0, 10.0 mg/kg) versus placebo, Outcome 2: Adverse events: severe, at belimumab 10 mg/kg dose
4.3
4.3. Analysis
Comparison 4: Intravenous belimumab (1.0, 4.0, 10.0 mg/kg) versus placebo, Outcome 3: Adverse events: minor ‐ skin and subcutaneous skin combined data for doses of 1.0 mg/kg, 4 mg/kg, and 10 mg/kg
5.1
5.1. Analysis
Comparison 5: Oral prednisone versus placebo, Outcome 1: Secondary outcome (lupus‐specific): flare in skin disease
5.2
5.2. Analysis
Comparison 5: Oral prednisone versus placebo, Outcome 2: Adverse events: minor
5.3
5.3. Analysis
Comparison 5: Oral prednisone versus placebo, Outcome 3: Adverse events: severe
6.1
6.1. Analysis
Comparison 6: Oral chloroquine versus placebo, Outcome 1: Primary outcome (lupus‐specific): absence of skin lesions
6.2
6.2. Analysis
Comparison 6: Oral chloroquine versus placebo, Outcome 2: Primary outcome (lupus‐non‐specific): absence of alopecia
6.3
6.3. Analysis
Comparison 6: Oral chloroquine versus placebo, Outcome 3: Adverse events: severe
7.1
7.1. Analysis
Comparison 7: Oral fish oil versus placebo, Outcome 1: Adverse event (severe) requiring withdrawal from study ‐ GI side effect
8.1
8.1. Analysis
Comparison 8: Oral nicardipine versus placebo, Outcome 1: Secondary outcome (lupus‐non‐specific): severity of Raynaud's attacks ‐ 150 mm visual analogue scale
8.2
8.2. Analysis
Comparison 8: Oral nicardipine versus placebo, Outcome 2: Secondary outcome (lupus‐non‐specific): number of Raynaud's attacks per day
8.3
8.3. Analysis
Comparison 8: Oral nicardipine versus placebo, Outcome 3: Adverse events: severe
8.4
8.4. Analysis
Comparison 8: Oral nicardipine versus placebo, Outcome 4: Adverse events: minor ‐ cardiovascular or GI side effect
9.1
9.1. Analysis
Comparison 9: Oral ginsenosides versus placebo, Outcome 1: Primary outcome (lupus‐specific): complete clearance of facial erythema
9.2
9.2. Analysis
Comparison 9: Oral ginsenosides versus placebo, Outcome 2: Primary outcome (lupus‐specific): complete clearance of aphthae
9.3
9.3. Analysis
Comparison 9: Oral ginsenosides versus placebo, Outcome 3: Primary outcome (lupus‐specific): complete clearance of erythema of hands
9.4
9.4. Analysis
Comparison 9: Oral ginsenosides versus placebo, Outcome 4: Primary outcome (lupus‐non‐specific): complete clearance of alopecia
9.5
9.5. Analysis
Comparison 9: Oral ginsenosides versus placebo, Outcome 5: Primary outcome (lupus‐non‐specific): complete clearance of oedema
9.6
9.6. Analysis
Comparison 9: Oral ginsenosides versus placebo, Outcome 6: Adverse events: minor ‐ side effect from medication
10.1
10.1. Analysis
Comparison 10: Intravenous rituximab versus placebo, Outcome 1: Adverse events: severe ‐ severe event not including death
10.2
10.2. Analysis
Comparison 10: Intravenous rituximab versus placebo, Outcome 2: Adverse events: severe ‐ death
11.1
11.1. Analysis
Comparison 11: Intravenous abatacept versus placebo, Outcome 1: Secondary outcome (lupus‐specific): BILAG A or B flare in discoid lesions
11.2
11.2. Analysis
Comparison 11: Intravenous abatacept versus placebo, Outcome 2: Secondary outcome (lupus‐specific): new BILAG A score for discoid lesions
11.3
11.3. Analysis
Comparison 11: Intravenous abatacept versus placebo, Outcome 3: Secondary outcome (lupus‐specific): new flare in discoid lesions (based on physician‐based assessment)
11.4
11.4. Analysis
Comparison 11: Intravenous abatacept versus placebo, Outcome 4: Adverse events: severe
12.1
12.1. Analysis
Comparison 12: Oral zileuton versus placebo, Outcome 1: Lupus‐non‐specific secondary outcome: SLAM score integument domain (mean change from baseline)
12.2
12.2. Analysis
Comparison 12: Oral zileuton versus placebo, Outcome 2: Adverse events: severe
13.1
13.1. Analysis
Comparison 13: Intravenous sifalimumab versus placebo, Outcome 1: Secondary outcome (lupus‐specific): proportion with "SLE flare" for combined doses vs placebo
13.2
13.2. Analysis
Comparison 13: Intravenous sifalimumab versus placebo, Outcome 2: Secondary outcome: proportion with improvement in "CLASI" at 200 mg dose
13.3
13.3. Analysis
Comparison 13: Intravenous sifalimumab versus placebo, Outcome 3: Secondary outcome: proportion with improvement in "CLASI" at 600 mg dose
13.4
13.4. Analysis
Comparison 13: Intravenous sifalimumab versus placebo, Outcome 4: Secondary outcome: proportion with improvement in "CLASI" at 1200 mg dose
13.5
13.5. Analysis
Comparison 13: Intravenous sifalimumab versus placebo, Outcome 5: Secondary outcome: proportion with improvement in "CLASI" at combined doses
13.6
13.6. Analysis
Comparison 13: Intravenous sifalimumab versus placebo, Outcome 6: Adverse events: severe (death)
13.7
13.7. Analysis
Comparison 13: Intravenous sifalimumab versus placebo, Outcome 7: Adverse events: all severe adverse events including death
13.8
13.8. Analysis
Comparison 13: Intravenous sifalimumab versus placebo, Outcome 8: Adverse events: all severe adverse events
13.9
13.9. Analysis
Comparison 13: Intravenous sifalimumab versus placebo, Outcome 9: Adverse events: minor ‐ pruritus, papular rash, or pruritic rash for combined doses
13.10
13.10. Analysis
Comparison 13: Intravenous sifalimumab versus placebo, Outcome 10: Adverse events: minor ‐ viral infection rash such as herpes zoster or herpes simplex for combined doses
13.11
13.11. Analysis
Comparison 13: Intravenous sifalimumab versus placebo, Outcome 11: Adverse events: minor for all doses combined
13.12
13.12. Analysis
Comparison 13: Intravenous sifalimumab versus placebo, Outcome 12: Adverse events: minor
14.1
14.1. Analysis
Comparison 14: Intravenous sirukumab versus placebo, Outcome 1: Adverse events: severe for combined doses vs placebo
14.2
14.2. Analysis
Comparison 14: Intravenous sirukumab versus placebo, Outcome 2: Adverse event: minor for combined doses vs placebo
15.1
15.1. Analysis
Comparison 15: Intravenous blisibimod versus placebo, Outcome 1: Adverse events: severe ‐ all severe events including death
16.1
16.1. Analysis
Comparison 16: intravenous epratuzumab versus placebo, Outcome 1: Adverse events
17.1
17.1. Analysis
Comparison 17: Intravenous atacicept versus placebo, Outcome 1: Adverse events: minor ‐ eczema, atacicept 3 mg/kg
17.2
17.2. Analysis
Comparison 17: Intravenous atacicept versus placebo, Outcome 2: Adverse events: minor ‐ local site reaction (redness, bruising, tenderness) for all doses combined
17.3
17.3. Analysis
Comparison 17: Intravenous atacicept versus placebo, Outcome 3: Adverse events: minor ‐ other minor reaction (not eczema or local site reaction)
18.1
18.1. Analysis
Comparison 18: Subcutaneous tabalumab versus placebo, Outcome 1: Adverse events
19.1
19.1. Analysis
Comparison 19: Oral baricitinib versus placebo, Outcome 1: Adverse events
20.1
20.1. Analysis
Comparison 20: Intravenous and subcutaneous ustekinumab versus placebo, Outcome 1: Secondary outcome: CLASI activity score: greater than 50% improvement from baseline
20.2
20.2. Analysis
Comparison 20: Intravenous and subcutaneous ustekinumab versus placebo, Outcome 2: Adverse events
21.1
21.1. Analysis
Comparison 21: Topical R932333 versus placebo vehicle, Outcome 1: Adverse events
22.1
22.1. Analysis
Comparison 22: Subcutaneous lulizumab versus placebo, Outcome 1: Adverse events
23.1
23.1. Analysis
Comparison 23: Intravenous belimumab versus intravenous belimumab dose comparison, Outcome 1: Adverse events: severe, 1 mg/kg vs 10 mg/kg
23.2
23.2. Analysis
Comparison 23: Intravenous belimumab versus intravenous belimumab dose comparison, Outcome 2: Adverse events: skin and subcutaneous tissue, 1 mg/kg vs 4 mg/kg
23.3
23.3. Analysis
Comparison 23: Intravenous belimumab versus intravenous belimumab dose comparison, Outcome 3: Adverse events: skin and subcutaneous tissue, 1 mg/kg vs 10 mg/kg
23.4
23.4. Analysis
Comparison 23: Intravenous belimumab versus intravenous belimumab dose comparison, Outcome 4: Adverse events: skin and subcutaneous tissue, 4 mg/kg vs 10 mg/kg
24.1
24.1. Analysis
Comparison 24: Intravenous atacicept versus intravenous atacicept dose comparison, Outcome 1: Adverse events: minor ‐ eczema
24.2
24.2. Analysis
Comparison 24: Intravenous atacicept versus intravenous atacicept dose comparison, Outcome 2: Adverse events: other minor adverse event (not eczema or local site reaction)
25.1
25.1. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 1: Secondary outcome: proportion with improvement in "CLASI" at 200 mg dose vs 600 mg dose
25.2
25.2. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 2: Secondary outcome: proportion with improvement in "CLASI" at 600 mg dose vs 1200 mg dose
25.3
25.3. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 3: Secondary outcome: proportion with improvement in "CLASI" at 200 mg dose vs 1200 mg dose
25.4
25.4. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 4: Adverse events: severe ‐ all, including death at 200 mg dose vs 600 mg dose
25.5
25.5. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 5: Adverse events: severe ‐ all, including death at 600 mg dose vs 1200 mg dose
25.6
25.6. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 6: Adverse events: severe ‐ all, including death at 200 mg dose vs 1200 mg dose
25.7
25.7. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 7: Adverse events: severe ‐ all, including death at 0.3 mg/kg dose vs 1 mg/kg dose
25.8
25.8. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 8: Adverse events: severe ‐ all, including death at 0.3 mg/kg dose vs 3 mg/kg dose
25.9
25.9. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 9: Adverse events: severe ‐ all, including death at 0.3 mg/kg dose vs 10 mg/kg dose
25.10
25.10. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 10: Adverse events: severe ‐ all, including death at 1 mg/kg dose vs 3 mg/kg dose
25.11
25.11. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 11: Adverse events: severe ‐ all, including death at 1 mg/kg dose vs 10 mg/kg dose
25.12
25.12. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 12: Adverse events: severe ‐ all, including death at 3 mg/kg dose vs 10 mg/kg dose
25.13
25.13. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 13: Adverse events: severe ‐ death at 0.3 mg/kg dose vs 1 mg/kg dose
25.14
25.14. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 14: Adverse events: severe ‐ death at 0.3 mg/kg dose vs 10 mg/kg dose
25.15
25.15. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 15: Adverse events: severe ‐ death at 1 mg/kg dose vs 3 mg/kg dose
25.16
25.16. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 16: Adverse events: severe ‐ death at 1 mg/kg dose vs 10 mg/kg dose
25.17
25.17. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 17: Adverse events: severe ‐ death at 3 mg/kg dose vs 10 mg/kg dose
25.18
25.18. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 18: Adverse events: minor ‐ zoster at 0.3 mg/kg dose vs 3 mg/kg dose
25.19
25.19. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 19: Adverse events: minor ‐ zoster at 0.3 mg/kg dose vs 10 mg/kg dose
25.20
25.20. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 20: Adverse events: minor ‐ zoster at 1 mg/kg dose vs 3 mg/kg dose
25.21
25.21. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 21: Adverse events: minor ‐ zoster at 1 mg/kg dose vs 10 mg/kg dose
25.22
25.22. Analysis
Comparison 25: Intravenous sifalimumab versus intravenous sifalimumab dose comparison, Outcome 22: Adverse events: minor ‐ zoster at 3 mg/kg dose vs 10 mg/kg dose
26.1
26.1. Analysis
Comparison 26: Oral clofazimine versus oral chloroquine, Outcome 1: Primary outcome (lupus‐specific): complete clearance of malar, SCLE, or discoid rash
26.2
26.2. Analysis
Comparison 26: Oral clofazimine versus oral chloroquine, Outcome 2: Primary outcome (lupus‐specific): partial clearance of malar, SCLE, or discoid rash
26.3
26.3. Analysis
Comparison 26: Oral clofazimine versus oral chloroquine, Outcome 3: Adverse events: severe ‐ severe flare in lupus requiring withdrawal from study
26.4
26.4. Analysis
Comparison 26: Oral clofazimine versus oral chloroquine, Outcome 4: Adverse events: minor
27.1
27.1. Analysis
Comparison 27: Oral ciclosporin versus oral azathioprine, Outcome 1: Primary outcome (lupus‐specific): complete clearance of malar rash (intent‐to‐treat analysis)
27.2
27.2. Analysis
Comparison 27: Oral ciclosporin versus oral azathioprine, Outcome 2: Primary outcome (lupus‐specific): complete clearance of oral ulcers (intent‐to‐treat analysis)
27.3
27.3. Analysis
Comparison 27: Oral ciclosporin versus oral azathioprine, Outcome 3: Adverse events: all severe events combined
27.4
27.4. Analysis
Comparison 27: Oral ciclosporin versus oral azathioprine, Outcome 4: Adverse events: subset of severe adverse events due to lack of effect of medication only
27.5
27.5. Analysis
Comparison 27: Oral ciclosporin versus oral azathioprine, Outcome 5: Adverse events: minor
28.1
28.1. Analysis
Comparison 28: Oral methotrexate versus oral chloroquine, Outcome 1: Primary outcome (lupus‐specific): complete clearance of skin rash (ITT analysis)
28.2
28.2. Analysis
Comparison 28: Oral methotrexate versus oral chloroquine, Outcome 2: Primary outcome (lupus‐specific): complete clearance of skin rash (authors' per‐protocol analysis)
28.3
28.3. Analysis
Comparison 28: Oral methotrexate versus oral chloroquine, Outcome 3: Primary outcome (lupus‐specific): complete clearance of skin rash during 6 month study (subset of patients with skin findings at baseline)
28.4
28.4. Analysis
Comparison 28: Oral methotrexate versus oral chloroquine, Outcome 4: Adverse events
29.1
29.1. Analysis
Comparison 29: Oral mycophenolate versus azathioprine or dapsone, Outcome 1: Primary outcome (lupus‐specific): partial improvement
29.2
29.2. Analysis
Comparison 29: Oral mycophenolate versus azathioprine or dapsone, Outcome 2: Adverse events
30.1
30.1. Analysis
Comparison 30: Oral Zi Shen Qing (Chinese herbal medicine) versus hydroxychloroquine, Outcome 1: Adverse events: severe
30.2
30.2. Analysis
Comparison 30: Oral Zi Shen Qing (Chinese herbal medicine) versus hydroxychloroquine, Outcome 2: Adverse events: minor
31.1
31.1. Analysis
Comparison 31: Intravenous ciclosporin A plus steroids versus intravenous steroids alone, Outcome 1: Primary outcome (lupus‐specific): complete resolution of erythematous manifestations
31.2
31.2. Analysis
Comparison 31: Intravenous ciclosporin A plus steroids versus intravenous steroids alone, Outcome 2: Adverse events
32.1
32.1. Analysis
Comparison 32: Intravenous rituximab versus intravenous cyclophosphamide, Outcome 1: Adverse events: minor ‐ cutaneous rash, itching
33.1
33.1. Analysis
Comparison 33: "Early treatment" (serology) with prednisone and/or cytotoxic agents versus "later treatment" (clinical flare), Outcome 1: Adverse events: minor
33.2
33.2. Analysis
Comparison 33: "Early treatment" (serology) with prednisone and/or cytotoxic agents versus "later treatment" (clinical flare), Outcome 2: Adverse events: severe
34.1
34.1. Analysis
Comparison 34: Intravenous pulse high‐dose cyclophosphamide versus intravenous monthly lower‐dose cyclophosphamide, Outcome 1: Adverse events: severe ‐ death
34.2
34.2. Analysis
Comparison 34: Intravenous pulse high‐dose cyclophosphamide versus intravenous monthly lower‐dose cyclophosphamide, Outcome 2: Adverse events: severe ‐ infection, cardiac arrest (not including death)
35.1
35.1. Analysis
Comparison 35: Topical tacrolimus versus topical clobetasol, Outcome 1: Primary outcome (lupus‐specific): erythema
35.2
35.2. Analysis
Comparison 35: Topical tacrolimus versus topical clobetasol, Outcome 2: Primary outcome (lupus‐specific): desquamation
35.3
35.3. Analysis
Comparison 35: Topical tacrolimus versus topical clobetasol, Outcome 3: Primary outcome (lupus‐specific): skin induration
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References

References to studies included in this review

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    1. Van Vollenhoven RF, Hahn BH, Tsokos GC, Wagner CL, Lipsky P, Tourma Z, et al. Efficacy and safety of ustekinumab, an IL-12 and IL-23 inhibitor, in patients with active systemic lupus erythematosus: results of a multicentre, double-blind, phase 2, randomised, controlled study. Lancet 2018;392(10155):1330-39. [CENTRAL: CN-01649927] [PMID: ] - PubMed
Wallace 2009 {published data only}
    1. Merrill JT, Furie RA, Wallace DJ, Stohl W, Chatham WW, Weinstein A, et al. Sustained disease improvement and safety profile over 1745 patient-year experience (7 years) with belimumab in patients with systemic lupus erythematosus. Lupus 2013;22(1):102. [EMBASE: 71177006]
    1. Merrill JT, Weinstein A, Wallace DJ, McKay J, Petri M, Furie R, et al. Safety and sustained disease activity improvement over the 1500 patient-year experience (6 years) with belimumab in SLE patients. International Journal of Rheumatic Diseases 2012;15(Suppl 1):74. [CENTRAL: CN-01030716] [EMBASE: 70887593]
    1. Petri M, Gallacher A, Wallace DJ, Thomas M, Levy RA, Van Vollenhoven RF, et al. Safety profile of belimumab in phase 2 and 3 clinical trials of patients with active SLE. International Journal of Rheumatic Diseases 2012;15(Suppl 1):73-4. [CENTRAL: CN-01030717]
    1. Wallace DJ, Navarra S, Gallacher A, Guzman R, Thomas M, Furie RA, et al. Safety profile of belimumab, a BlyS-specific inhibitor, in patients with active systemic lupus erythematosus (SLE): Pooled data from phase 2 and 3 studies. Arthritis and Rheumatism 2010;62(Suppl 10):1172. [EMBASE: 70381905]
    1. Wallace DJ, Stohl W, Furie RA, Lisse JR, McKay JD, Merrill JT, et al. A phase II, randomized double-blind placebo controlled dose ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis and Rheumatism 2009;61(9):1168-78. [CENTRAL: CN-00721369] - PMC - PubMed
Wallace 2013 {published data only}
    1. Hobbs K, Strand V, Wallace DJ, Kalunian K, Nikai E, Kilgallen B, et al. Epratuzumab: improvements in disease activity and quality of life. International Journal of Rheumatic Diseases 2014;17(Suppl 1):61-2. [DOI: 10.1111/1756-185x.12344] - DOI
    1. Wallace PJ, Gordon C, Strand V, Hobbs K, Petri M, Petri M, et al. Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from two randomized,double-blind, placebo-controlled, multicentre studies (ALLEVIATE) and follow-up. Rheumatology 2013;52(7):1313-22. [CENTRAL: CN-00964591] [PMID: ] - PubMed
Wallace 2014 {published data only}
    1. Gordon C, Clowse M, Houssiau F, Petri M, Kilgallen B, Kalunian K, et al. Epratuzumab: improvements in disease activity over 2-years in SL0008C. International Journal of Rheumatic Disease 2014;17(Suppl 1):39. [DOI: 10.1111/1756-185x.12344] - DOI
    1. Wallace DJ, Hobbs K, Clowse ME, Petri M, Strand V, Pike M, et al. Long-term safety and efficacy of epratuzumab in the treatment of moderate-to- severe systemic lupus erythematosus: results from an open-label extension study. Arthritis Care and Research 2016;68(4):534-43. [CENTRAL: CN-01140978] [DOI: 10.1002/acr.22694] [PMID: ] - DOI - PubMed
    1. Wallace DJ, Kalunian K, Petri MA, Strand V, Houssiau FA, Pike M, et al. Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicenter study. Annals of the Rheumatic Diseases 2014;73(1):183-90. [CENTRAL: CN-00961058] [PMID: ] - PMC - PubMed
Wallace 2018 {published data only}
    1. Tanaka Y, Wallace DJ, Furie RA, Kalunian KC, Mosca M, Petri MA, et al. Baricitinib in systemic lupus erythematosus (SLE): results from a phase 2, randomized, double-blind, placebo-controlled study. International Journal of Rheumatic Diseases 2018;21(S1):42-3. [CENTRAL: CN-01653238] [DOI: 10.1111/1756-185X.13361] - DOI
    1. Wallace DJ, Furie RA, Tanaka Y, Kalunian KC, Mosca M, Petri MA, et al. Baricitinib in systemic lupus erythematosus (SLE): results from a phase 2, randomized, double-blind, placebo-controlled study. Annals of the Rheumatic Diseases 2018;77(Suppl 2):59. [CENTRAL: CN-01647565] [DOI: 10.1136/annrheumdis-2018-eular.1918] - DOI
    1. Wallace DJ, Furie RA, Tanaka Y, Kalunian KC, Mosca M, Petri MA. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. The Lancet 2018;392(10143):222-31. [CENTRAL: CN-01616970] - PubMed
Walton 1991 {published data only}
    1. Walton AJ, Snaith ML, Locniskar M, Cumberland AG, Morrow WJ, Isenberg DA. Dietary fish oil and the severity of symptoms in patients with systemic lupus erythematosus. Annals of Rheumatic Diseases 1991;50(7):463-6. [CENTRAL: CN-00077665] - PMC - PubMed
Werth 2017a {published data only}
    1. Furie R, Werth V, Gaudy A, Ye Y, Korish S, Azaryan A, et al. A randomized, placebo-controlled, double-blind, ascending-dose, safety, and pharmacokinetics study of CC-220 in subjects with systemic lupus erythematosus. Arthritis and Rheumatism 2017;69(Suppl 10):887. [CENTRAL: CN-01423876]
    1. Furie R, Werth V, Lee E, Box E, Fondal M, Kivitz A, et al. A phase 2, randomized, placebo-controlled, double blind, ascending dose study to evaluate efficacy, safety, and tolerability of CC 220 in subjects with systemic lupus erythematosus. Clinical and Experimental Rheumatology 2016;34(Suppl 99):S77. [CENTRAL: CN-01360336]
    1. Werth V, Furie R, Gaudy A, Ye Y, Korish S, Delev N, et al. CC-220 decreases B-cell subsets and plasmacytoid dendritic cells in systemic lupus erythematosus (SLE) patients and is associated with skin improvement: Pharmacodynamic results from a phase IIa proof of concept study. Arthritis and Rheumatology 2017;69(Suppl 10):886. [CENTRAL: CN-01423880]
    1. Werth V, Furie R, Korish S, Weiswasser M, Azaryan A, Schafer P, et al. A randomized, placebo-controlled, double-blind, ascending-dose, safety study of CC-220 in subjects with systemic lupus erythematosus. Annals of the Rheumatic Diseases 2017;76(Suppl 2):870-1. [CENTRAL: CN-01467692] [DOI: 10.1136/annrheumdis-2017-eular.3546] - DOI
Westberg 1990 {published data only}
    1. Westberg G, Tarkowski A. Effect of MaxEPA in Patients with SLE. A double-blind, crossover study. Scandavian Journal of Rheumatology 1990;19(2):137-43. [CENTRAL: CN-00067446] - PubMed
Williams 1994 {published data only}
    1. Williams HJ, Egger MJ, Singer JZ, Willkens RF, Kalunian KC, Clegg DO, et al. Comparison of hydroxychloroquine and placebo in the treatment of arthropathy of mild systemic lupus erythematosus. Journal of Rheumatology 1994;21(8):1457-62. [CENTRAL: CN-00107474] - PubMed
Wright 2008 {published data only}
    1. Wright SA, O'Prey FM, McHenry MT, Leahey WJ, Devine AB, Duffy EM et al. A randomized interventional trail of omega-3-polyunsaturated fatty acids on endothelial function and disease activity in systemic lupus erythematosus. Annals of Rheumatic Diseases 2008;67(6):841-8. [CENTRAL: CN-00636996] - PubMed
Yahya 2013 {published data only}
    1. Yahya F, Jasmin R, Ng CT, Cheah TE, Sockalingam S. Open label randomized controlled trial assessing the efficacy of mycophenolate sodium against other conventional immunosuppressive agents in active systemic lupus erythematosus without renal involvement. International Journal of Rheumatic Diseases 2013;16(6):724-30. [CENTRAL: CN-00961067] - PubMed
Yokogawa 2015 {published data only}
    1. Yokogawa N, Eto H, Tanikawa A, Ikeda T, Yamamoto K, Takahashi T, et al. Effects of hydroxychloroquine in patients with cutaneous lupus erythematosus: A multicenter, double-blind, randomized, parallel-group trial. Arthritis and Rheumatology 2017;69(4):791-9. [CENTRAL: CN-01365894] [PMID: ] - PubMed
    1. Yokogawa N, Takahashi T, Sato T, Yokota N. A double-blind, randomized, parallel-group study of hydroxychloroquine on cutaneous lupus erythematosus in Japan. Arthritis and Rheumatology 2015;67(Suppl 10):No pagination. [CENTRAL: CN-01162609] [EMBASE: 72095665] - PubMed
You 2010 {published data only}
    1. You YL, Feng YL, Cai Q, Guan JL, Zhang LL, Xu MJ, et al. Efficacy of ginsenosides combined with prednisone in patients with systemic lupus erythematosus: a prospective, randomized double blind placebo controlled trial. Zhong Xi Yi Jie He Xue Bao [Journal of Chinese Integrative Medicine] 2010;8(8):762-6. [CENTRAL: CN-00858531] - PubMed
Zhong 2013 {published data only}
    1. Zhong LLD, Bian ZX, Gu JH, Zhou X, Tian Y, Mao JC, et al. Chinese herbal medicine (Zi Shen Qing) for mild-to-moderate systematic lupus erythematosus: a pilot prospective, single blinded randomized controlled study. Evidence-Based Complementary and Alternative Medicine 2013;327245:No pagination. [CENTRAL: CN-00906171] [EMBASE: 2013362297] - PMC - PubMed

References to studies excluded from this review

Abdou 2008 {published data only}
    1. Abdou NI, Rider V, Greenwell C, Li X, Kimler BF. Fulvestrant (Faslodex), an estrogen selective receptor down-regulator, in therapy of women with systemic lupus erythematosus. clinical, serologic, bone density, and T cell activation marker studies: a double-blind placebo-controlled trial. Journal of Rheumatology 2008;35(5):797. [CENTRAL: CN-00638660] - PubMed
Abud‐Mendoza 2009 {published data only}
    1. Abud-Mendoza C, Moreno-Valdés R, Cuevas-Orta E, Borjas A, Aranda F, Irazoque F, et al. Treating severe systemic lupus erythematosus with rituximab. An open study. Reumatologia Clinica 2009;5(4):147-52. [PMID: ] - PubMed
Barikbin 2009 {published data only}
    1. Barikbin B, Givrad S, Yousefi M. Pimecrolimus 1% cream versus betamethasone 17-valerate 0.1% cream in the treatment of facial discoid lupus erythematosus: a double-blind randomized pilot study. Clinical and Experimental Dermatology 2009;34(7):776-80. [CENTRAL: CN-00731922] - PubMed
Bhattoa 2004 {published data only}
    1. Bhattoa HP, Bettembuk P, Balogh A, Szegedi G, Kiss E. The effect of 1-year transdermal estrogen replacement therapy on bone mineral density and biochemical markers of bone turnover in osteopenic postmenopausal systemic lupus erythematosus patients: a randomized, double-blind, placebo-controlled trial. Osteoporosis International 2004;15(5):396-404. [CENTRAL: CN-00482463] - PubMed
Bjornberg 1963 {published data only}
    1. Bjornberg A, Hellgren L. Treatment of chronic discoid lupus erythematosus with fluocinolone acetonide ointment. British Journal of Dermatology 1963;75:156-60. [CENTRAL: CN-00421306] - PubMed
Cai 2006 {published data only}
    1. Cai XY, Xu YL, Lin XJ. Effects of radix astragali injection on apoptosis of lymphocytes and immune function in patients with systemic lupus erythematosus. Zhongguo Zhong Xi Yi Jie He Za Zhi [Chinese Journal of Integrated Traditional and Western Medicine] 2006;26(5):443-5. [CENTRAL: CN-00617426] - PubMed
Chang 2002 {published data only}
    1. Chang DM, Lan JL, Lin HY, Luo SF. Dehydroepiandrosterone treatment of women with mild to moderate systemic lupus erythematosus, a multicenter randomized double-blind placebo-controlled trial. Arthritis and Rheumatism 2002;46(11):2924-7. [CENTRAL: CN-00411325] - PubMed
Chang 2016a {published data only}
    1. Chang HH, Luo SF, Hsue YT, Chang CM, Lee TY, Huang YC, et al. Modulation of endothelial injury by traditional Chinese Medicine LC in systemic lupus erythematosus. Scientific Reports 2016;6:19622. [PMID: ] - PMC - PubMed
ChiCTR‐12002402 {unpublished data only}
    1. ChiCTR-TRC-12002402. Clinical study about the SLEDAI-reducing and glucocorticoid-withdrawing effect on compound Qing Hao oral liquid on mild to moderate systemic lupus erythematosus. www.chictr.org.cn/showprojen.aspx?proj=7148 (first received 2 August 2012).
Furie 2008 {published data only}
    1. Furie R, Stohl W, Ginzler EM, Becker M, Mishra N, Chatham W, et al. Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus. Arthritis Research and Therapy 2008;10(5):R109. [CENTRAL: CN-00665759] - PMC - PubMed
Furie 2011a {published data only}
    1. Furie R, Nicholls K, Cheng TT, Houssiau F, Burgos-Vargas R, Chen SL, et al. Efficacy and safety of abatacept over 12 months in patients with lupus nephritis: Results from a multicenter, randomized, double-blind, placebo-controlled phase II/III study. Arthritis and Rheumatism 2011;63(S10):S962. [CENTRAL: CN-01032675]
Ginzler 2013 {published data only}
    1. Ginzler EM, Wallace DJ, Merrill JT, Furie RA, Stohl W, Chatham WW, et al. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus. Journal of Rheumatology 2014;41(2):300-9. [PMID: ] - PubMed
Gordon 2008 {published data only}
    1. Gordon C, Wallace DJ, Shinada S, Kalunian KC, Forbess L, Braunstein GD, et al. Testosterone patches in the management of patients with mild/moderate systemic lupus erythematosus. Rheumatology (Oxford, England) 2008;47(3):334-8. [CENTRAL: CN-00629736] - PubMed
Handa 1985 {published data only}
    1. Handa F, Puri KPS. A randomized double-blind study of ointments containing diflucortolone valerate and hydrocortisone acetate. Indian Journal of Dermatology, Venereology and Leprology 1985;51(5):261-2. [CENTRAL: CN-00692728] - PubMed
He 2016 {published data only}
    1. He J, Zhang X, Wei Y, Yu D, Li Z. Low-dose interleukin-2 selectively modifies CD4+ T cell subsets in SLE. European Journal of Immunology 2016;46(S1):3725.
Hummers 2013 {published data only}
    1. Hummers LK, Dugowson CE, Dechow FJ, Wise RA, Gregory J, Michalek J, et al. A multi-centre, blinded, randomised, placebo-controlled, laboratory-based study of mqx-503, a novel topical gel formulation of nitroglycerine, in patients with Raynaud's phenomenon. Annals of the Rheumatic Diseases 2013;72(12):1962-7. [CENTRAL: CN-00983064] - PubMed
Jemec 2009 {published data only}
    1. Jemec GB, Ulman S, Goodfield M, Bygum A, Olesen AB, Berth-Jones J et al. A randomized controlled trial of R-salbutamol for topical treatment of discoid lupus erythematosus. British Journal of Dermatology 2009;161(6):1365-70. [CENTRAL: CN-00742338] - PubMed
Kahl 2016 {published data only}
    1. Kahl L, Patel J, Layton M, Binks M, Hicks K, Leon G et al. Safety, tolerability, efficacy and pharmacodynamics of the selective JAK1 inhibitor GSK2586184 in patients with systemic lupus erythematosus. Lupus 2016;25(3):1420-30. [CENTRAL: CN-01379928] - PubMed
Kraak 1965 {published data only}
    1. Kraak JH, Ketel W, Prakken JR, Zwet WR. The value of hydroxychloroquine (Plaquenil) for the treatment of chronic discoid lupus erythematosus; a double blind trial. Dermatologica 1965;130:293-305. [CENTRAL: CN-00360327] - PubMed
Kuhn 2011a {published data only}
    1. Kuhn A, Gensch K, Haust M, Meuth AM, Boyer F, Dupuy P, et al. Photoprotective effects of a broad-spectrum sunscreen in ultraviolet-induced cutaneous lupus erythematosus: a randomized, vehicle-controlled, double-blind study. Journal of the American Academy of Dermatology 2011;64(1):37-48. [CENTRAL: CN-00770562] - PubMed
Liao 2011 {published data only}
    1. Liao YN, Liu CS, Tsai TR, Hung YC, Chang SJ, Lin HL, et al. Preliminary study of a traditional Chinese medicine formula in systemic lupus erythematosus patients to taper steroid dose and prevent disease flare-up. Kaohsiung Journal of Medical Sciences 2011;27(7):251-7. [CENTRAL: CN-00798778] - PMC - PubMed
Liu 2007 {published data only}
    1. Liu SQ, Chen XJ. The effectiveness of Zi Shen Qing formula on regulation of CD4, CD25 with mild to moderate active systemic lupus erythematosus. Liao Ning Journal of Traditional Chinese Medicine 2007;34(12):1669-70.
Lu 2015 {unpublished data only}
    1. Lu P, Fleishmann R, Curtis C, Ignatenko S, Desai M, Wong SL, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the BCL-2 Inhibitor venetoclax (ABT-199) in a phase 1 single and multiple ascending dose study in female patients with systemic lupus erythematosus. Arthritis and Rheumatism 2015;67(Suppl 10):738.
Mok 2016 {published data only}
    1. Mok CC, Penn HJ, Chan KL, Tse SM, Langman LJ, Jannetto PJ. Hydroxychloroquine serum concentrations and flares of systemic lupus erythematosus: a longitudinal cohort analysis. Arthritis Care and Research 2016;68(9):1295-302. [PMID: ] - PubMed
NCT00523588 {unpublished data only}
    1. NCT00523588. Treatment of cutaneous lupus erythematosus (CLE) with 595 NM flash lamp pulsed dye laser. clinicaltrials.gov/ct2/show/NCT00523588 (first received 31 August 2007).
NCT00775476 {unpublished data only}
    1. NCT00775476. Treatment of systemic lupus erythematosus (SLE) with N-acetylcysteine (NAC). clinicaltrials.gov/ct2/show/NCT00775476 (first received 20 October 2008).
NCT01135459 {unpublished data only}
    1. NCT01135459. A study to evaluate the efficacy and safety of CEP-33457 in patients with systemic lupus erythematosus. clinicaltrials.gov/ct2/show/NCT01135459 (first received 2 June 2010).
NCT01470313 {unpublished data only}
    1. NCT01470313. A multiple dose study of PD-0360324 in patients with active cutaneous lupus erythematosus. clinicaltrials.gov/ct2/show/NCT01470313 (first received 11 November 2011).
NCT01498406 {unpublished data only}
    1. NCT01498406. Vitamin D status, disease specific and quality of life outcomes in patients with cutaneous lupus. clinicaltrials.gov/ct2/show/NCT01498406 (first received 23 December 2011).
NCT01516788 {unpublished data only}
    1. NCT01516788. Photoprovocation testing in subjects with cutaneous lupus. clinicaltrials.gov/ct2/show/NCT01516788 (first received 25 January 2012).
NCT01689025 {unpublished data only}
    1. NCT01689025. An investigation of safety and tolerability of NNC0114-0006 in subjects with systemic lupus erythematosus (SLE). clinicaltrials.gov/ct2/show/NCT01689025 (first received 20 September 2012).
NCT01709474 {unpublished data only}
    1. NCT01709474. Vitamin D3 treatment in pediatric systemic lupus erythematosus. clinicaltrials.gov/ct2/show/NCT01709474 (first received 18 October 2012).
NCT02074020 {unpublished data only}
    1. NCT02074020. CHABLIS-SC2: a study of the efficacy and safety of subcutaneous blisibimod in subjects with systemic lupus erythematosus with or without nephritis. clinicaltrials.gov/ct2/show/NCT02074020 (first received 28 February 2014).
NCT02265744 {unpublished data only}
    1. NCT02265744. Safety and efficacy of BMS-931699 versus placebo to treat systemic lupus erythematosus. clinicaltrials.gov/ct2/show/NCT02265744 (first received 16 October 2014).
NCT02514967 {unpublished data only}
    1. NCT02514967. CHABLIS7.5: a study of the efficacy and safety of subcutaneous blisibimod in subjects with systemic lupus erythematosus with or without nephritis. clinicaltrials.gov/ct2/show/NCT02514967 (first received 4 August 2015).
NCT02711813 {unpublished data only}
    1. NCT02711813. TAB08 in patients with systemic lupus erythematosus (SLE), not adequately controlled with current treatment. clinicaltrials.gov/ct2/show/NCT02711813 (first received 17 March 2016).
NCT02975336 {unpublished data only}
    1. NCT02975336. A phase II study of M2951 in systemic lupus erythematosus (SLE) [A phase II, randomized, double-blind, placebo-controlled dose-ranging study to evaluate the safety and efficacy of M2951 in subjects with systemic lupus erythematosus (SLE)]. clinicaltrials.gov/ct2/show/NCT02975336 (first received 29 November 2016).
Nordmark 2005 {published data only}
    1. Nordmark G, Bengtsson C, Larsson A, Karlsson FA, Sturfelt G, Ronnblom L. Effects of dehydroepiandrosterone supplement of health related quality of life in glucocorticosteroid treated female patients with systemic lupus erythematosus. Autoimmunity 2005;38(7):531-40. [CENTRAL: CN-00532586] - PubMed
Ohtsuka 2013 {published data only}
    1. Ohtsuka K, Miwa Y, Oguro N, Miura Y, Ishii S, Seki S, et al. Efficacy of tacrolimus combination therapy during maintenance phase of systemic lupus erythematosus. Arthritis and Rheumatism 2013;65:S667 Abstract #1571.
Okon 2014 {published data only}
    1. Okon L, Rosenbach M, Krathen M, Rose M, Propert K, Okawa J, et al. Lenalidomide in treatment-refractory cutaneous lupus erythematosus: efficacy and safety in a 52-week trial. Journal of the American Academy of Dermatology 2014;70(3):583-4. [PMID: ] - PMC - PubMed
Partan 2019 {published data only}
    1. Partan RU, Hidayat R, Saputra N, Rahmayani F, Prapto H, Yudha TW et al. Seluang fish (Rasbora Spp.) oil decreases inflammatory cytokines via increasing vitamin D level in systemic lupus erythematosus. Macedonia Journal of Medical Science 2019;7(9):1418-21. - PMC - PubMed
Petri 2002 {published data only}
    1. Petri MA, Lahita RG, VanVollenhoven RF, Merrill JT, Schiff M, Ginzler EM, et al. Effects of prasterone on corticosteroid requirements of women with systemic lupus erythematosus. Arthritis and Rheumatism 2002;46(7):1820-9. [CENTRAL: CN-00390315] - PubMed
Pothinamthong 2012 {published data only}
    1. Pothinamthong P, Janjumratsang P. A comparative study in efficacy and safety of 0.1% tacrolimus and 0.05% clobetasol propionate ointment in discoid lupus erythematosus by modified cutaneous lupus erythematosus disease area and severity index. Chotmaihet Thangphaet [Journal of the Medical Association of Thailand] 2012;95(7):933-40. [CENTRAL: CN-00879175] - PubMed
Presto 2018 {published data only}
    1. Presto JK, Okon LG, Feng R, Wallace DJ, Furie R, Fiorentino D, et al. Computerized planimetry to assess clinical responsiveness in a phase II randomized trial of topical R333 for discoid lupus erythematosus. British Journal of Dermatology 2018;178(6):1308-14. [PMID: ] - PubMed
Roenigk 1980 {published data only}
    1. Roenigk HH, Martin JS, Eichorn P, Gilliam JN. Discoid lupus erythematosus. Diagnostic features and evaluation of topical corticosteroid therapy. Cutis; Cutaneous Medicine for the Practitioner 1980;25(3):281-5. [CENTRAL: CN-00269334] - PubMed
Rovin 2019 {published data only}
    1. Rovin BH, Solomons N, Pendergraft WF, Dooley MA, Tumlin J, Romero-Diaz J, et al. A randomized, controlled double-blind study comparing the efficacy and safety of dose-ranging voclosporin with placebo in achieving remission in patients with active lupus nephritis. Kidney International 2019;95(1):219-31. - PubMed
Ruzicka 1992 {published data only}
    1. Ruzicka T, Sommerburg C, Goerz G, Kind P, Mensing H. Treatment of cutaneous lupus erythematosus with acitretin and hydroxychloroquine. British Journal of Dermatology 1992;127(5):513-8. [CENTRAL: CN-00089526] - PubMed
Shamekhi 2017 {published data only}
    1. Shamekhi Z, Amani R, Habibagahi Z, Namjoyan F, Ghadiri A, Malehi AS. A randomized, double blind, placebo controlled, clinical trial examining the effects of green tea extract on SLE activity and quality of life. Phytotherapy Research : PTR 2017;31(7):1063-71. [CENTRAL: CN-01396081] - PubMed
Stege 2000 {published data only}
    1. Stege H, Budde MA, Grether-Beck S, Krutmann J. Evaluation of the capacity of sunscreens to photoprotect lupus erythematosus patients by employing the photoprovocation test. Photodermatology, Photoimmunology and Photomedicine 2000;16(6):256-259. [CENTRAL: CN-00329506] - PubMed
Sticherling 2007 {published data only}
    1. Sticherling M, Gelbrich G, Rogalski C. Topical pimecrolimus for cutaneous lupus erythematosus-results of a double blind placebo controlled trial. Journal der Deutschen Dermatologischen Gesellschaft 2007;5:S188-9.
Tsuru 2016 {unpublished data only}
    1. Tsuru T, Tanaka Y, Kishimoto M, Saito K, Yoshizawa S, Takasaki Y, et al. Safety, pharmacokinetics, and pharmacodynamics of epratuzumab in Japanese patients with moderate-to-severe systemic lupus erythematosus: Results from a phase 1/2 randomized study. Modern Rheumatology 2016;26(1):87-93. [CENTRAL: CN-01128396] [PMID: ] - PubMed
Vieira 2009 {published data only}
    1. Vieira CS, Pereira FV, Sa MF, Paulo LJ, Martins WP, et al. Tibolone in postmenopausal women with systemic lupus erythematosus: a pilot study. Maturitas 2009;62(3):311-6. [CENTRAL: CN-00700364] - PubMed
Wang 1989 {published data only}
    1. Wang BX, Yuan ZZ. A tablet of Tripterygium wilfordii in treating lupus erythematosus. Zhong Xi Yi Jie He Za Zhi [Chinese Journal of Modern Developments in Traditional Medicine] 1989;9(7):407-8. [PMID: ] - PubMed
Werth 2013 {published data only}
    1. Werth VP, Fiorentino D, Cohen SB, Fivenson D, Hansen C, Zoog S, et al. A phase I single-dose crossover study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical efficacy of AMG 811 (anti-IFN-gamma) in subjects with discoid lupus erythematosus. Arthritis and Rheumatism 2013;65(S10):S682-3. [CENTRAL: CN-01063414]
Xu 2012 {published data only}
    1. Xu XF, Qu HR, Xiang ZY, Mao JC, Zhao BJ, Wang X, et al. Effects of Ziyin Jiedu Quyu decoction on glucocorticoid dosage in systemic lupus erythematosus: a double blind randomized controlled trial. Shang Hai Journal of Traditional Chinese Medicine 2012;46(1):33-6.
Zhang 2019 {published data only}
    1. Zhang M, Qi C, Zha Y, Chen J, Luo P, Wang, Li et al. Leflunomide versus cyclophosphamide in the induction treatment of proliferative lupus nephritis in Chinese patients: a randomized trial. Clinical Rheumatology 2019;38(3):859-67. - PubMed

References to studies awaiting assessment

Askenase 2019 {published data only}
    1. Askanase AD, Zhao E, Zhu J, Connolly-Strong E, Furie RA. A multicenter, double‐blind, randomised, placebo‐controlled, 24‐week clinical trial evaluating the effect of repository corticotropin injection (RCI) in reducing disease activity for patients with persistently active SLE despite moderate‐dose corticosteroid use. Lupus 10.1136/lupus-2020-000383;(first accessed on September 8, 2020).
Brunner 2020 {published data only}
    1. Brunner HI, Abud-Mendoza C, Viola DO, Calvo-Penades I, Levy D, Anton J, et al. Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial. Annals of Rheumatological Disease 2020;0:1-9. - PMC - PubMed
    1. NCT01649765. Paediatric lupus trial of belimumab plus background standard therapy (PLUTO). clinicaltrials.gov/ct2/show/NCT01649765 (first received 25 July 2012).
Hasni 2019 {published data only}
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He 2019 {published data only}
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NCT02446899 {unpublished data only}
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NCT02446912 {unpublished data only}
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NCT02554019 {unpublished data only}
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NCT02847598 {unpublished data only}
    1. NCT02847598. Study to evaluate BIIB059 in cutaneous lupus erythematosus (CLE) with or without systemic lupus erythematosus (SLE) (LILAC). clinicaltrials.gov/ct2/show/NCT02847598 (first received 28 July 2016).
NCT03958955 {unpublished data only}
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Tanaka 2020 {published data only}
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References to ongoing studies

ISRCTN47873003 {unpublished data only}ISRCTN47873003
    1. ISRCTN47873003. Belimumab after B-cell depletion as new treatment for systemic lupus erythematosus. www.isrctn.com/search?q=ISRCTN47873003 (first received 28 November 2016).
NCT01781611 {unpublished data only}
    1. NCT01781611. Dipyridamole assessment for flare reduction in systemic lupus erythematosus (SLE). clinicaltrials.gov/ct2/show/NCT01781611 (first received 1 February 2013).
NCT02270957 {unpublished data only}
    1. NCT02270957. Clarification of abatacept effects in SLE with integrated biologic and clinical approaches (ABC). clinicaltrials.gov/ct2/show/NCT02270957 (first received 22 October 2014).
NCT02660944 {unpublished data only}
    1. NCT02660944. A phase 2a of RSLV-132 in subjects with systemic lupus erythematosus (SLE). clinicaltrials.gov/ct2/show/NCT02660944 (first received 21 January 2016).
NCT02822989 {unpublished data only}
    1. NCT02822989. Using the cholinergic anti-inflammatory pathway to treat systemic lupus musculoskeletal pain. clinicaltrials.gov/ct2/show/NCT02822989 (first received 6 July 2016).
NCT03161483 {unpublished data only}
    1. NCT03161483. Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus. clinicaltrials.gov/ct2/show/NCT03161483 (first received 19 May 2017).
NCT03252587 {unpublished data only}
    1. NCT03252587. An investigational study to evaluate BMS-986165 in patients with systemic lupus erythematosus. clinicaltrials.gov/ct2/show/NCT03252587 (first received on 17 August 2017).
NCT03451422 {unpublished data only}
    1. NCT03451422. Safety and efficacy of AMG 592 in subjects with active systemic lupus erythematosus. clinicaltrials.gov/ct2/show/NCT03451422 (first received on 1 March 2018).
NCT03517722 {unpublished data only}
    1. NCT03517722. A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of ustekinumab in subjects with active systemic lupus erythematosus. clinicaltrials.gov/ct2/show/NCT03517722 (first accessed 8 September 2020).
NCT03616912 {unpublished data only}
    1. NCT031616912. A randomized, double-blind, placebo-controlled, parallel-group, phase 3 study of baricitinib in patients with systemic lupus erythematosus (Brave 1 trial). clinicaltrials.gov/ct2/show/NCT031616912 (first accessed 8 September 2020).
NCT03616964 {unpublished data only}
    1. NCT03616964. A randomized, double-blind, placebo-controlled, parallel-group, phase 3 study of baricitinib in patients with systemic lupus erythematosus (BRAVE II trial). clinicaltrials.gov/ct2/show/NCT03616964 (first accessed on 8 September 2020).
NCT03845517 {unpublished data only}
    1. NCT03845517. A phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus. www.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2018-004175-12-BG (first received 8 September 2020).
NCT03978520 {unpublished data only}
    1. NCT03978520 and EUCTR-2019-000638-20-ES. A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of ABBV-105 and upadacitinib given alone or in combination (ABBV-599 Combination) in subjects with moderately to severely active systemic lupus erythematosus. www.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2019-000638-20-ES (first accessed 8 September 2020).
NCT04058028 {unpublished data only}
    1. EUCTR2018-004175-12-BG and NCT04058028. A study to evaluate the efficacy and safety of AMG 570 in subjects with active systemic lupus erythematosus (SLE) with inadequate response to standard of care (SOC) therapy. clinicaltrials.gov/ct2/show/NCT04058028 (first received 8 September 2020).
NCT04060888 {unpublished data only}
    1. NCT04060888. A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of ustekinumab in Chinese subjects with active systemic lupus erythematosus. clinicaltrials.gov/ct2/show/NCT04060888 (first accessed 8 September 2020).
Teng 2019 {unpublished data only}
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