Tumor necrosis factor (TNF) inhibitors for psoriatic arthritis
- PMID: 39945386
- PMCID: PMC11822884
- DOI: 10.1002/14651858.CD013614.pub2
Tumor necrosis factor (TNF) inhibitors for psoriatic arthritis
Abstract
Background: Psoriatic arthritis (PsA) is a chronic arthritis affecting people with psoriasis. If untreated, it may lead to disability. Recommended drugs are non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), and targeted synthetic DMARDs (tsDMARDs). Tumour necrosis factor inhibitors (TNFi) are the first choice bDMARDs.
Objectives: To assess the benefits and harms of TNFi in adults with psoriatic arthritis.
Search methods: We searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov and the World Health Organization trials portal up to 28 March 2024.
Selection criteria: We included randomized controlled trials (RCTs) in adults with PsA, comparing TNFi to placebo, physiotherapy, NSAIDs, corticosteroids, and cs/b/tsDMARDs. Major outcomes included clinical improvement, minimal disease activity, physical function, health-related quality of life, radiographic progression, serious adverse events, and withdrawals due to adverse events.
Data collection and analysis: We used standard Cochrane methods. The primary comparison was TNFi versus placebo. The primary time point was 12 weeks for clinical improvement; 24 weeks for minimal disease activity, function, quality of life, and radiographic progression; and the end of the trial period for serious adverse events and withdrawals due to adverse events.
Main results: We included 25 RCTs randomizing 7857 participants. Four studies compared TNFi to methotrexate and one to ustekinumab in DMARD-naïve participants. In csDMARD-inadequate responders, 11 studies compared TNFi to placebo; four studies compared TNFi to placebo and ixekizumab, bimekizumab, tofacitinib, or upadacitinib; and three studies compared TNFi to ixekizumab, secukinumab, and ustekinumab. Two studies compared different TNFi. We found no studies with b/tsDMARD-inadequate responders (b/tsDMARD-IR). No studies compared TNFi to NSAIDs, corticosteroids, or physiotherapy. Performance (32%), detection (56%) and reporting (80%) biases were at high or unclear risk across studies. Only one study had a low risk of bias in all domains. We limit reporting to the primary comparison, TNFi versus placebo. DMARD-naïve We found no studies comparing TNFi with placebo in DMARD-naïve participants. csDMARD-inadequate responders TNFi probably result in a large clinical improvement compared to placebo. At 12 weeks, 149/1926 (8%) participants in the placebo group showed a clinical improvement (ACR50) compared to 784/2141 (37%) participants in the TNFi group (risk ratio (RR) 5.63, 95% confidence interval (CI) 3.98 to 7.96; I2 = 65%; 14 studies, 4067 participants; moderate-certainty evidence). TNFi probably result in a higher proportion of participants in minimal disease activity. At 24 weeks, 95/1017 (9%) participants in the placebo group were in minimal disease activity compared to 428/1336 (32%) participants in the TNFi group (RR 3.76, 95% CI 2.39 to 5.92; I2 = 72%; 5 studies, 2353 participants; moderate-certainty evidence). At 24 weeks, TNFi may improve function compared to placebo. The mean change in function from baseline (assessed with the Health Assessment Questionnaire; score from 0 to 3, 0 = no disability; minimal clinically important difference (MCID) = 0.35) was -0.14 points with placebo and 0.33 points lower (0.41 lower to 0.25 lower) with TNFi (I2 = 72%; 8 studies, 2949 participants; low-certainty evidence). TNFi probably result in a clinically important improvement in health-related quality of life. The mean change in quality of life from baseline (assessed with the Short Form 36-item Mental Component Summary questionnaire; score from 0 to 100, 100 = best score; MCID = 1.7) was 2.4 points with placebo and 3.29 points higher (2.18 points higher to 4.40 points higher) with TNFi (I2 = 52%; 8 studies, 2928 participants; moderate-certainty evidence). TNFi probably slightly reduce radiographic progression. The mean change in radiographic progression (assessed with the Sharp/Van der Heijde-PsA score; scale from 0 to 528, 0 = no damage) was 0.25 points with placebo and 0.37 points lower with TNFi (0.48 lower to 0.25 lower) (I2 = 32%; 7 studies, 2478 participants; moderate-certainty evidence) at 24 weeks. We downgraded the evidence to moderate certainty for clinical improvement, minimal disease activity, quality of life, and radiographic progression due to risk of bias. For function, we downgraded the evidence to low certainty for risk of bias and imprecision. TNFi may result in little to no difference in serious adverse events, but may slightly increase withdrawals due to adverse events, compared to placebo. At the end of follow-up: 56/1826 participants (3%) given placebo and 69/1900 (4%) participants given TNFi experienced serious adverse events (RR 1.00, 95% CI 0.70 to 1.42; I2 = 0%; 13 studies, 3866 participants; low-certainty evidence); and 35/1926 (2%) participants given placebo and 65/2140 (3%) given TNFi withdrew due to adverse events (RR 1.53, 95% CI 1.01 to 2.33; I2 = 0%; 14 studies, 4066 participants; low-certainty evidence). We downgraded the evidence to low certainty for risk of bias and imprecision.
Authors' conclusions: In csDMARD-inadequate responders, moderate-certainty evidence showed that TNFi probably result in a large clinical improvement, lower disease activity, small decrease in radiographic progression, and better quality of life compared to placebo. Low-certainty evidence showed that TNFi may lead to a slight improvement in physical function compared to placebo. Low-certainty evidence suggested that TNFi may lead to a slight increase in withdrawals due to adverse events, whereas they may result in little to no difference in serious adverse events compared to placebo. No trials assessed TNFi compared to placebo in DMARD-naïve participants or in b/tsDMARD-IR.
Copyright © 2025 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Conflict of interest statement
GC has no direct financial interests. GC's institution has received payments from Abbvie, GSK, Janssen, Lilly, Novartis, Pfizer, Zenas Biopharma for GC's work as local site investigator in multiple international clinical trials, investigating treatments for different rheumatic diseases. GC has no control over the funding.
MC has received payment for development of a meeting report and participation fee for the American College of Rheumatology annual meeting in 2019 from Sanofi.
AS was employed as an independent contractor (consultant; 25 April 2022) by US Pharmacia to develop a brochure (authorship), and undertake an interview and workshop. This consultancy focused on functional constipation in children and has no bearing on this review.
CAS has received fees for consultancy (< 2000 euros) from AbbVie and Bristol Meyer Squibb pharmaceuticals.
MB is an Associate Editor with the Cochrane Neonatal Group, but took no part in the acceptance or editorial processes for this review. Skåne University Hospital received a public grant to fund MB's salary 0.5 FTE for basic research, not related to his Cochrane work.
Update of
- doi: 10.1002/14651858.CD013614
References
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Mease 2020 {published and unpublished data}
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- CTRI/2017/09/009850. Comparison of Ixekizumab with Adalimumab in Patients with Psoriatic Arthritis. http://www.who.int/trialsearch/Trial2.aspx?TrialID=CTRI/2017/09/009850 2017.
-
- EUCTR2016-004585-25-SE. A Study of Ixekizumab Versus Adalimumab in Participants With Psoriatic Arthritis. http://www.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2016-004585-25-SE 2017.
-
- Husni E, Kamat S, Stenger K, Bolce R, Holzkaemper T, Helt C, et al. The effect of ixekizumab versus adalimumab on individual components of the acr composite score, with and without concomitant methotrexate or other conventional synthetic DMARDs at 52 weeks in patients with psoriatic arthritis. Arthritis and Rheumatology 2021;73(Suppl 9):3752-4.
-
- Husni ME, Kamat S, Stenger KB, Bolce R, Holzkaemper T, Helt CC, et al. The effect of ixekizumab versus adalimumab on individual components of the ACR composite score, with and without concomitant methotrexate or other conventional synthetic DMARDS at 52 weeks in patients with psoriatic arthritis. Internal Medicine Journal 2022;52(Suppl 3):322022.
-
- Kiprianos A, Husni E, Kamat S, Brooke Stenger K, Bolce R, Holzkaemper T, et al. The effect of ixekizumab versus adalimumab on individual components of the ACR composite score, with and without concomitant methotrexate or other conventional synthetic DMARDS, at 52 weeks in patients with psoriatic arthritis. Rheumatology (United Kingdom) 2022;61(Suppl 1):i1512022.
Torii 2010 {published and unpublished data}
-
- Torii H, Nakagawa H. Infliximab monotherapy in Japanese patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. A randomized, double-blind, placebo-controlled multicenter trial. Journal of Dermatological Science 2010;59(1):40-9. - PubMed
Van Mens 2019 {published and unpublished data}
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- De Jong HM, Van Mens LJ, Nurmohamed MT, Kok MR, Van Kuijk AW, Baeten DL, et al. Sustained remission with methotrexate monotherapy after 22-week induction treatment with TNF-alpha inhibitor and methotrexate in early psoriatic arthritis: an open-label extension of a randomized placebo-controlled trial. Arthritis Research & Therapy 2019;21(1):208. - PMC - PubMed
-
- EUCTR2012-005214-19-NL. A randomized, double-blind, placebo-controlled trial of golimumab+methotrexate versus methotrexate alone in methotrexate-naïve patients with psoriatic arthritis. http://www.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2012-005214-19-NL 2013.
-
- NCT01871649. Initial Treatment With Golimumab in Early PsA. https://clinicaltrials.gov/show/NCT01871649 2013.
-
- Van Mens L, De Jong J, Fluri I, Van De Sande M, Nurmohamed M, Kok MR, et al. Achieving remission in psoriatic arthritis by early initiation of TNF inhibition: a double-blind, randomized, placebo-controlled trial of golimumab + methotrexate versus placebo + methotrexate. Arthritis & Rheumatology 2018;70:1835-6. - PubMed
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- Van Mens LJ, Jong HM, Fluri I, Nurmohamed MT, Van de Sande MG, Kok M, et al. Achieving remission in psoriatic arthritis by early initiation of TNF inhibition: a double-blind, randomised, placebo-controlled trial of golimumab plus methotrexate versus placebo plus methotrexate. Annals of the Rheumatic Diseases 2019;78(5):610-6. - PubMed
Vieira‐Sousa 2020 {published and unpublished data}
-
- EUCTR2013-000643-40-PT. Golimumab efficacy in psoriatic arthritis patients with active dactylitis. http://www.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2013-000643-40-PT 2013.
-
- NCT02065713. Efficacy of Golimumab in Combination With Methotrexate (Mtx) Versus Mtx Monotherapy, in Improving Dactylitis, in Mtx naïve Psoriatic Arthritis Patients. https://clinicaltrials.gov/ct2/show/NCT02065713 2014.
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- Vieira-Sousa E, Alves P, Rodrigues AM, Teixeira F, Tavares-Costa J, Bernardo A, et al. GO-DACT: a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis. Annals of the Rheumatic Diseases 2020;79(4):490‐8. - PMC - PubMed
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- Vieira-Sousa E, Alves P, Rodrigues AM, Teixeira F, Tavares-Costa J, Bernardo A, et al. GO-DACT: a randomized double-blind placebocontroled proof-of-concept trial of golimumab plus methotrexate (MTX) versus mtx monotherapy, in improving dactylitis, in MTX naive psoriatic arthritis patients. Annals of the Rheumatic Diseases 2019;78:1266. - PMC - PubMed
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- Vieira-Sousa E, Canhão H, Alves P, Rodrigues AM, Teixeira F, Tavares-Costa J, et al. The GO-DACT protocol: a multicentre, randomized, double-blind, parallel-group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy. Acta Reumatologica Portuguesa 2018;43(2):80-92. - PubMed
References to studies excluded from this review
Asahina 2010 {published data only}
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- Asahina A, Nakagawa H, Etoh T, Ohtsuki M. Adalimumab in Japanese patients with moderate to severe chronic plaque psoriasis: Efficacy and safety results from a Phase II/III randomized controlled study. Journal of Dermatology 2010;37(4):299-310. - PubMed
Atzeni 2011 {published data only}
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- Atzeni F, Boccassini L, Antivalle M, Salaffi F, Sarzi-Puttini P. Etanercept plus ciclosporin versus etanercept plus methotrexate for maintaining clinical control over psoriatic arthritis: a randomised pilot study. Ann Rheum Dis 2011;70(4):712-4. - PubMed
Augustin 2017 {published data only}
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- Augustin M, Calimlim B, Williams D, Geng Z, Skup M, Recih K. Adalimumab improves health-related quality of life in patients with fingernail psoriasis. Journal of the American Academy of Dermatology 2017;76(6):AB33.
Barker 2011 {published data only}
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- Barker J, Hoffmann M, Wozel G, Ortonne J P, Zheng H, Van Hoogstraten H, Reich K. Efficacy and safety of infliximab vs. Methotrexate in patients with moderate-to-severe plaque psoriasis: Results of an open-label, active-controlled, randomized trial (RESTORE1). British Journal of Dermatology 2011;165(5):1109-1117. - PubMed
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- Euctr B E. An Open-Label, Randomized Efficacy and Safety Study of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis. http://www.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2005-000085-39-BE 2006.
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- Nct. The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED). https://www.clinicaltrials.gov/ct2/show/NCT00251641 2005.
Bissonnette 2017 {published data only}
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- Bissonnette R, Luger T, Thaçi D, Toth D, Lacombe A, Xia S, Mazur R, Patekar M, Charef P, Milutinovic M, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). Journal of the European Academy of Dermatology and Venereology : JEADV 2018;32(9):1507‐1514. - PMC - PubMed
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- Bissonnette R, Luger T, Thaçi D, Toth D, Letzelter K, Xia S, Mazur R, Milutinovic M, Leonardi C. Secukinumab demonstrates sustained high efficacy and a favorable safety profile in moderate to severe psoriasis patients through 4 years of treatment (extension of sculpture study). International Journal of Dermatology 2017;56(11):1265.
Blauvelt 2017a {published data only}
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- Blauvelt A, Papp KA, Griffiths CEM, Shen YK, Li S, Kimball AB, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. Journal of the American Academy of Dermatology 2017;76(3):405-17. - PubMed
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- Griffiths C E, Papp K A, Kimball A B, Randazzo B, Wasfi Y, Li S, Shen Y K, Blauvelt A. Two-year efficacy and safety of guselkumab for treatment of moderate-to-severe psoriasis: Phase 3 voyage 1 trial. Annals of the Rheumatic Diseases 2018;77:1580-1581.
Blauvelt 2017b {published data only}
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- Blauvelt A, Reich K, Papp K A, Griffiths C E M, Armstrong A W, Foley P, Shen Y K, Kimball A B, Gordon K B. Consistency of response across subgroups of patients with psoriasis treated with guselkumab: Results from the VOYAGE 1 and 2 trials. Journal of the American Academy of Dermatology 2017;76(6):AB83.
Bolt 2021 {published data only}
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- Bolt J, Van Kuijk A W R, Teunissen M B, De Hair M J H, Van Der Coelen D, Aarrass S, Gerlag D M, Tak P P, Van De Sande M, Lebre M C, Van Baarsen L G M. Adalimumab has no significant effect on interleukin-17 and interleukin-17 receptor expression in skin and synovium of psoriatic arthritis patients with mild psoriasis. Journal of psoriasis and psoriatic arthritis 2021;6(4):207. - PMC - PubMed
Burmester 2021 {published data only}
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- Burmester Gerd R, Kevin W, Ricardo B, Peter N, Philippe G, Azevedo Valderilio F, Carlo S, Andrea R R, Elizabeth L, McCaskill Reva M, John L, Bosny P L J, Sandra W, Ralph L, Apinya L, Ruderman Eric M. Safety profile of upadacitinib up to 3 years in patients with psoriatic arthritis: an integrated analysis from the phase 3 program. Swiss medical weekly 2021;151(SUPPL 252):26S.
Carron 2017 {published data only}
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- Carron P, Varkas G, Cypers H, Van Praet L, Elewaut D, Van Den Bosch F. Efficacy and safety of golimumab in patients with active, very early peripheral spondyloarthritis: First results from the CRESPA study, a monocentric, placebo-controlled randomized trial. Annals of the Rheumatic Diseases 2016;75:802.
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- Carron P, Varkas G, Cypers H, Van Praet L, Elewaut D, Van den Bosch F. Anti-TNF-induced remission in very early peripheral spondyloarthritis: the CRESPA study. Annals of the Rheumatic Diseases 2017;76(8):1389-1395. - PubMed
ChiCTR2400079755 {published data only}
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- An open randomized controlled trial of Upadacitinib to improve anxiety in patients with psoriatic arthritis. trialsearch.who.int 2024:Trial ID: ChiCTR2400079755.
Choy 2009 {published data only}
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- Choy E H S, Gladman D D, Mease P J, Ritchlin C T, Olds M, Wong R L, Wang S, Medich J. ADalimumab for Psoriatic arthritis: Improvement in Psoriasis is associated with long-term inhibition of radiographic progression. Journal of Rheumatology 2009;36(11):2571.
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- Choy E, Gladman D, Mease P J, Ritchlin C, Olds M, Wong R L, Wang S, Medich J. In patients with psoriatic arthritis receiving adalimumab, improvement in psoriasis is associated with long-term inhibition of radiographic progression. Rheumatology 2009;48:i56-i57.
Coates 2009 {published data only}
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- Coates L C, Helliwell P S. Achieving minimal disease activity (MDA) criteria with anti-TNF therapy in psoriatic arthritis can prevent progressive joint damage. Arthritis and Rheumatism 2009;60:2022.
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- Coates L C, Helliwell P S. Achieving minimal disease activity criteria with anti-TNF therapy in psoriatic arthritis can prevent progressive joint damage. Rheumatology 2010;49:i17-i18.
Coates 2010a {published data only}
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- Coates L C, Helliwell P S. Validation of minimal disease activity criteria for psoriatic arthritis using interventional trial data. Arthritis Care Res (Hoboken) 2010;62(7):965-9. - PubMed
Coates 2018 {published data only}
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- Coates L C, Mease P J, Chen K, Hojnik M, Valdecantos W, Sheth P, Aletaha D, Ganz F. Long-term inhibition of radiographic progression with originator adalimumab in patients with moderate to severe psoriatic arthritis with or without radiographic damage at baseline. Arthritis and Rheumatology 2018;70:2916-2917.
Coates 2019 {published data only}
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- Coates L, Merola J, Mease P, Ogdie A, Gladman D, Strand V, Van Mens L, Liu L, Yen P K, Collier D, et al. The performance characteristics of composite measures used in a randomized trial examining etanercept and methotrexate as monotherapy or in Combination in Patients with Psoriatic Arthritis. Arthritis & rheumatology 2019;71:2715‐2718.
Coates 2020 {published data only}
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- Coates L C, Tillett W, D'Agostino M A, Rahman P, Behrens F, Conaghan P G, McDearmon-Blondell E, Bu X, Chen L, Kapoor M, et al. Adalimumab introduction versus methotrexate dose escalation in patients with inadequately controlled psoriatic arthritis: results from randomized phase 4 control study. Annals of the rheumatic diseases 2020;79(SUPPL 1):33‐. - PubMed
Coates 2021 {published data only}
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- Coates L C, Sandoval D, Bolce R, Lin C Y, Stenger K, Sprabery A T, Kavanaugh A. Ixekizumab treatment response: consistency over time and at each visit in psoriatic arthritis. Annals of the rheumatic diseases 2021;80(SUPPL 1):1301‐1302.
Coates 2022 {published data only}
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- Coates L C, Abraham S, Tillett W, Mease P J, Ramiro S, Wu T, Wang X, Pangan A L, Song I H. Performance and Predictors of Minimal Disease Activity Response in Patients With Peripheral Spondyloarthritis Treated With Adalimumab. Arthritis care & research 2022;74(2):259-267. - PubMed
Combe 2016 {published data only}
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- Combe B, Behrens F, McHugh N, Brock F, Kerkmann U, Kola B, Gallo G. Comparison of Etanercept Monotherapy and Combination Therapy with Methotrexate in Psoriatic Arthritis: Results from 2 Clinical Trials. J Rheumatol 2016;43(6):1063-7. - PubMed
D'Angelo 2010 {published data only}
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- D'Angelo S, Cutro M S, Lubrano E, Leccese P, Mennillo G A, Ferrara N, Olivieri I. Combination therapy with ciclosporin and etanercept in patients with psoriatic arthritis. Ann Rheum Dis 2010;69(5):934-5. - PubMed
de Vries 2017 {published data only}
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- Vries A C Q, Thio H B, Kort W J A, Opmeer B C, Stok H M, Jong E M G J, Horvath B, Busschbach J J V, Nijsten T E C, Spuls P I. A prospective randomized controlled trial comparing infliximab and etanercept in patients with moderate-to-severe chronic plaque-type psoriasis: the Psoriasis Infliximab vs. Etanercept Comparison Evaluation (PIECE) study. British Journal of Dermatology 2017;176(3):624-633. - PubMed
Dougados 2014 {published data only}
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- Dougados M, Van Der Heijde D, Sieper J, Braun J, Maksymowych W P, Citera G, Pedersen R, Bonin R, Bukowski J, Koenig A S, Vlahos B, Alvarez D. Clinical and imaging efficacy of etanercept in early non-radiographic axial spondyloarthritis: A 12-week, randomized, double-blind, placebo-controlled trial. Annals of the Rheumatic Diseases 2013;72:87.
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- Dougados M, Heijde D, Sieper J, Braun J, Maksymowych WP, Citera G, et al. Symptomatic efficacy of etanercept and its effects on objective signs of inflammation in early nonradiographic axial spondyloarthritis: a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis & Rheumatology 2014;66(8):2091-102. - PubMed
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- Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes (EMBARK). https://clinicaltrials.gov/ct2/show/NCT01258738;2010.
Dougados 2019 {published data only}
Elewski 2017 {published data only}
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- Elewski BE, Rich PA, Behrens F, Guillet G, Geng Z. Primary efficacy and safety of adalimumab in nail psoriasis from the first 26 weeks of a phase-3, randomized, placebo-controlled trial with subanalysis in patients with and without psoriatic arthritis. Journal of the American Academy of Dermatology 2017;76:AB204.
Elewski 2018 {published data only}
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- Elewski BE, Rich PA, Behrens F, Guillet G, Geng Z, Servin OR. Primary efficacy and safety of adalimumab in nail psoriasis from the first 26 weeks of a phase-3, randomized, placebo-controlled trial with subanalysis in patients with and without psoriatic arthritis. In: Acta Dermato-Venereologica. Vol. 98. 2018:26-7.
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- Elewski BE, Okun MM, Papp K, Baker CS, Crowley JJ, Guillet G, et al. Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial. Journal of the American Academy of Dermatology 2018;78(1):90-9. - PubMed
Elewski 2019 {published data only}
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- Elewski BE, Armstrong AW, Coates LC, Rubel D, Geng Z, Gu Y, Reyes O, Behrens F. Efficacy of adalimumab in nail psoriasis by history of psoriatic arthritis and overall safety from final, open-label 26 weeks of a phase 3, randomized, placebo-controlled trial. Journal of the American Academy of Dermatology 2019;81(4):AB201.
Fitz 2017 {published data only}
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- Fitz Gerald O, Fleischmann R, Kavanaugh A, Hoepken B, Peterson L, Gladman D. The effect of certolizumab pegol on extra-articular manifestations of psoriatic arthritis over 4 years of treatment in patients with and without prior anti-TNF exposure. Annals of the Rheumatic Diseases 2017;76:681.
Formulary 2004 {published data only}
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- Etanercept efficacy for psoriatic arthritis sustained at 2 years. Formulary 2004;39(2):74.
Freundlich 2009 {published data only}
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- Freundlich B, Sterry W, Ortonne J P, Kirkham B, Robertson D, Molta C, Pedersen R. Results of a randomized, double-blind study to evaluate the efficacy and safety of etanercept in patients with psoriasis and psoriasis and psoriatic arthritis: The presta trial. Internal Medicine Journal 2009;39:A55.
Gladman 2012 {published data only}
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- Gladman D D, Fleischmann R M, Coteur G, Woltering F, Mease P. Effect of certolizumab pegol on the multiple facets of psoriatic arthritis as reported by patients: 24 week patient reported outcome results of a phase 3 double blind randomized placebo-controlled study. Arthritis and Rheumatism 2012;64:S242-S243.
Goedkoop 2004 {published data only}
Gottlieb 2019 {published data only}
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- Gottlieb AB, Merola JE, Schrom D, Sprabery AT. Rapid and sustained improvements in cutaneous and musculoskeletal signs and symptoms with 108 weeks treatment of ixekizumab in psoriatic arthritis in biologic-naive and TNF-inadequate responder patients. Journal of the American Academy of Dermatology 2019;81(4):AB262.
Griffiths 2015 {published data only}
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- Griffiths C E, Reich K, Lebwohl M, Van De Kerkhof P, Paul C, Menter A, Carlier H, Cameron G, Erickson J, Zhang L, Secrest R, Ball S, Braun D, Osuntokun O, Heffernan M, Nickoloff B, Papp K. A phase 3 trial comparing ixekizumab with placebo and etanercept for moderate-to-severe plaque psoriasis: Results from the 12 week induction period of UNCOVER-2. Journal of Investigative Dermatology 2015;135:S17.
Helliwell 2018 {published data only}
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- Helliwell P S, Coates L C, Gerald O F, Nash P, Soriano E R, Husni M E, Hsu M A, Kanik K S, Hendrikx T, Wu J, Kudlacz E. Tofacitinib improves composite endpoint measures of disease in patients with psoriatic arthritis. Arthritis and Rheumatology 2017;69(Suppl 10):-.
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- Helliwell P, Coates L C, FitzGerald O, Nash P, Soriano E R, Husni M E, Hsu M A, Kanik K S, Hendrikx T, Wu J, et al. Tofacitinib improves composite endpoint measures of disease in patients with psoriatic arthritis. Annals of the rheumatic diseases 2018;77:379‐380.
Helliwell 2020 {published data only}
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- Helliwell P, Mease P, Kavanaugh A, Coates L, Ogdie A, Deodhar A, Strand V, Maksabedian E, Kricorian G, Liu L, Collier D, Gladman D. What Influence Do Clinical Domains Other Than Arthritis Have on Composite Clinical Outcomes in Psoriatic Arthritis?: comparison of Treatment Effects in the SEAM-PsA Trial. Arthritis & rheumatology 2020;72 (SUPPL 10):2715-2717.
Holman 2008 {published data only}
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- Holman A J, Ng E. Heart rate variability predicts anti-tumor necrosis factor therapy response for inflammatory arthritis. Auton Neurosci 2008;143(1-2):58-67. - PubMed
Husni 2020 {published data only}
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- Husni M E, Gowin K, Gellett A M, Sprabery A T, Helt C C, Geneus V J, Rossini M, Gomez-Martin D. Ixekizumab demonstrates improvement comparable to adalimumab across acr components in biologic-nave patients with psoriatic arthritis. Journal of clinical rheumatology 2020;20(3 SUPPL 1):S99‐.
JPRN‐UMIN000027208 {published data only}
-
- A pilot study for the effect of infliximab on endothelial function in patients with psoriasis. http://www.who.int/trialsearch/Trial2.aspx?TrialID=JPRN-UMIN000027208 2017.
Kavanaugh 2009a {published data only}
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- Kavanaugh A, McLnnes I, Mease P, Krueger G G, Gladman D, Gomez-Reino J, Papp K, Zrubek J, Mudivarthy S, Mack M, Visvanathan S, Beutler A. Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty-four-week efficacy and safety Results of a randomized, placebo-controlled study. Arthritis and Rheumatism 2009;60(4):976-986. - PubMed
Kavanaugh 2014c {published data only}
Kavanaugh 2016a {published data only}
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- Kavanaugh A, Heijde D, Beutler A, Gladman D, Mease P, Krueger G G, McInnes I B, Helliwell P, Coates L C, Xu S. Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo-Controlled Study. Arthritis Care Res (Hoboken) 2016;68(2):267-74. - PMC - PubMed
Kavanaugh 2020 {published data only}
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- Kavanaugh A, Lubrano E, Muram T, Lin C Y, Liu Leage S, Van Den Bosch F, Kristensen L E. Head-to-head study evaluating the combined ACR50/PASI100 treatment response of ixekizumab versus adalimumab: individual patient data from a randomized, openlabel study in biologic-naive patients with psoriatic arthritis through week 52. Annals of the rheumatic diseases 2020;79(SUPPL 1):767‐.
Khatri 2019 {published data only}
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- Khatri A, Klünder B, Peloso P M, Othman A A. Exposure-response analyses demonstrate no evidence of interleukin 17A contribution to efficacy of ABT-122 in rheumatoid or psoriatic arthritis. Rheumatology (Oxford) 2019;58(2):352-360. - PubMed
Kimball 2015 {published data only}
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- Kimball A B, Nikai E, Zhu B, Carlier H, Yosipovitch G. Ixekizumab impact on itch severity compared to etanercept and placebo: Results from UNCOVER-2, a phase 3 trial in patients with moderate-to-severe plaque psoriasis. Journal of Investigative Dermatology 2015;135:S19.
Krankenpflege 2005 {published data only}
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- [Aldalimumab in psoriatic arthritis and as the initial therapy in rheumatoid arthritis] [Adalimumab bei Psoriasis-Arthritis und zur Initialtherapie bei rheumatoider Arthritis]. Krankenpflege Journal 2005;43(7-10):244. [PMID: ] - PubMed
Lacour 2015 {published data only}
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- Lacour J P, Dutronc Y, Zhang L. Efficacy of ixekizumab in patients with and without previous experience with biologic therapies compared to etanercept and placebo: Results from UNCOVER-2, a phase 3 trial in patients with plaque psoriasis. Journal of Investigative Dermatology 2015;135:S6.
McInnes 2020a {published data only}
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- McInnes I, Mease P, Gladman D, Coates L, Nash P, Ogdie A, Behrens F, Goupille P, Kavanaugh A, Martin R, et al. Residual Disease Activity in Psoriatic Arthritis Patients Treated with Secukinumab and Adalimumab Who Achieved Remission or Low Disease Activity: results from a Phase 3b, Randomized, Double-blinded, Active-controlled, Head-to-head Study. Arthritis & rheumatology 2020;72(SUPPL 10):1819‐1822.
Mease 2009a {published data only}
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- Mease P, Signorovitch J, Mulani P, Gupta S. The effect of adalimumab treatment for moderate to severe psoriasis on concurrent response for both psoriasis and psoriatic arthritis. Journal of the American Academy of Dermatology 2009;60(3):AB178.
Mease 2011 {published data only}
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- Mease P J, Woolley J M, Bitman B, Wang B C, Globe D R, Singh A. Minimally important difference of Health Assessment Questionnaire in psoriatic arthritis: relating thresholds of improvement in functional ability to patient-rated importance and satisfaction. J Rheumatol 2011;38(11):2461-5. - PubMed
Mease 2015 {published data only}
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- Mease P, Gladman D, Ritchlin C T, Warren R B, Rubant S, Li Y, Dorr A, Anderson J. Therapeutic response in adalimumab-treated patients with psoriatic arthritis in relation to weight. Journal of Investigative Dermatology 2015;135:S31.
Mease 2016 {published data only}
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- Mease, P J, Fleischmann, R, Wollenhaupt, J, Deodhar, A, Gladman, D, Hoepken, B, Peterson, L, Van Der Heijde, D. Improvements in joint outcomes of psoriatic arthritis over 4 years of treatment with certolizumab pegol in patients with and without prior anti-TNF exposure. Annals of the Rheumatic Diseases 2016;75:609.
Mease 2017 {published data only}
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- Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: Results from the 24-week randomised, double-blind, placebo controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Mease, P. J.; Van Der Heijde, D.; Ritchlin, C. T.; Okada, M.; Cuchacovich, R. S.; Shuler, C. L.; Lin, C. Y.; Braun, D. K.; Lee, C. H.; Gladman, D. D.. Annals of the Rheumatic Diseases 2017;76(1)::79-87. - PMC - PubMed
Mease 2019a {published data only}
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- Mease, P J, Husni, M E, Kafka, S, Chakravarty, S D, Harrison, D D, Lo, K H, Xu, S, Hsia, E C, Kavanaugh, A. Inhibition of radiographic progression was achieved with intravenous golimumab in active psa patients regardless of changes in composite indices of disease activity in a phase III trial. Annals of the Rheumatic Diseases 2019;78:1279-1280.
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- Mease, P, Kafka, S, Chakravarty, S, Harrison, D, Lo, K H, Xu, S, Hsia, E C, Kavanaugh, A. Inhibition of radiographic progression and correlation with changes in composite disease activity indices in patients with active psoriatic arthritis treated with intravenous golimumab, as measured in a phase III trial. Journal of Clinical Rheumatology 2019;25(3):S67.
Mehta 2018 {published data only}
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- Wan MT, Noe MH, Shin DB, Armstrong AW, Duffin KC, Chiesa Fuxench ZC, et al. The vascular inflammation in psoriasis (VIP) trial: a secondary analysis of patient reported outcomes for patients treated with adalimumab, phototherapy, or placebo. In: Journal of Investigative Dermatology. Vol. 139. 2019:S93. - PMC - PubMed
Menter 2011 {published data only}
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- Menter A, Signorovitch J, Sundaram M, Bao Y. Health-related quality of life outcomes in patients with moderate to severe psoriasis treated with ABT-874 versus etanercept or placebo. Journal of the American Academy of Dermatology 2011;64(2):AB160.
Merola 2019 {published data only}
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- Merola J, Sprabery AT, Gellett A, Lin C-Y, McGonagle D. Improvement in the signs and symptoms of psoriatic arthritis with ixekizumab compared to adalimumab in patient subgroups defined by baseline disease characteristics. Arthritis and rheumatology 2019;71:2627-2628.
Merola 2019a {published data only}
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- Merola J F, Chakravarty S D, You Y, Kafka S, Karyekar C, Orbai A E. Efficacy of Guselkumab in psoriasis patients with self-reported psoriatic arthritis with involvement of the scalp, nails, hands, and feet: a pooled analysis from 2 pivotal phase 3 psoriasis studies. Annals of the Rheumatic Diseases 2019;78:1855‐1856.
Merola 2020 {published data only}
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- Merola J F, Papp K A, Nash P, Gratacós J, Boehncke W H, Thaçi D, Graham D, Hsu M A, Wang C, Wu J, Young P. Tofacitinib in psoriatic arthritis patients: skin signs and symptoms and health-related quality of life from two randomized phase 3 studies. Journal of the European Academy of Dermatology and Venereology 2020;34(12):2809-2820. - PMC - PubMed
Nash 2018 {published data only}
NCT00106834 {published data only}
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- A Study of the Safety and Efficacy of Infliximab in Patients With Psoriasis. https://clinicaltrials.gov/show/NCT00106834 2005.
NCT00195689 {published data only}
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- Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis. https://clinicaltrials.gov/show/NCT00195689 2005.
NCT02694523 {published data only}
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- BI 655066 (risankizumab) compared to active comparator (adalimumab) in patients with moderate to severe chronic plaque psoriasis. http://www.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2015-003623-65-CZ 2016.
NCT02701205 {published data only}
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- Safety and Efficacy Study of Etanercept (Qiangke®) to Treat Moderate to Severe Plaque Psoriasis. https://clinicaltrials.gov/ct2/show/NCT02701205 2016.
NCT02814175 {published data only}
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- A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL). https://clinicaltrials.gov/ct2/show/NCT02814175 2016.
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- A study of subjects with Psoriatic Arthritis to investigate the effectiveness of adalimumab introduction compared with methotrexate dose escalation. http://www.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2016-000191-21-GB 2016;(): 2016.
Ogdie 2019 {published data only}
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- Ogdie A, Li N, Peterson S, Karyekar C, Chakravarty S, Kafka S, Walsh J. Multi-symptom impact on the EQ5D index in bio-naive active psoriatic arthritis patients: an analysis through week 24 of the go-vibrant study. Arthritis & rheumatology 2019;71:2594‐2595.
Okun 2016 {published data only}
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- Okun M, Yang M, Koo V, Sundaram M, Signorovitch J. Effects of adalimumab on health-related quality of life in psoriasis patients with and without comorbid psoriatic arthritis: Value of reducing PASI scores and systemic inflammation. Journal of the American Academy of Dermatology 2016;74(5):AB246.
Papp 2018 {published data only}
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- Papp K, Kimball A, Blauvelt A, Reich K, Gooderham M, Tyring S, Sinclair R, Thaci D, Zhao Y, Cichanowitz N, Li Q, Rosa C L. Effect of tildrakizumab on personal relationships in patients with moderate-to-severe chronic plaque psoriasis. Acta Dermato-Venereologica 2018;98:54.
Praiser 2017 {published data only}
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- Praiser D, Heffernan M, Dennehy E, See K, Goldblum O, Paul C. The effects of age, gender, weight, age at onset, psoriasis severity, nail involvement, and presence of psoriatic arthritis at baseline on the efficacy of ixekizumab in patients with moderate-tosevere psoriasis. Journal of the American Academy of Dermatology 2017;76(6):AB252.
Puig 2018 {published data only}
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- Puig L, Han C, Vender R, Song M, You Y, Shen Y K, Foley P. Impact of guselkumab versus placebo and adalimumab on patient reported outcomes in patients with and without psoriatic arthritis in a phase 3 pivotal psoriasis study. Arthritis and Rheumatology 2018;70:2861-2862.
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- Puig L, Han C, Vender R, Song M, You Y, Shen Y K, Foley P. Impact of guselkumab versus placebo and adalimumab on patient reported outcomes in patients with and without psoriatic arthritis in voyage 2. Acta Dermato-Venereologica 2018;98:50-51.
Ramos 2016 {published data only}
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- Ramos M I, Teunissen M B, Helder B, Aarrass S, Hair M J, Kuijk A W, Gerlag D M, Tak P P, Lebre M C. Reduced CLEC9A expression in synovial tissue of psoriatic arthritis patients after adalimumab therapy. Rheumatology (Oxford) 2016;55(9):1575-84. - PubMed
Reich 2015 {published data only}
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- Reich K, Toth D, Nikai E, Zhu B, Carlier H, Feldman S. Ixekizumab impact on health-related quality of life compared to etanercept and placebo: Results from UNCOVER-2, a phase 3 trial in patients with moderate-to-severe plaque psoriasis. Journal of Investigative Dermatology 2015;135:S35.
Reich 2016 {published data only}
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- Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis. https://clinicaltrials.gov/show/NCT01690299 2012.
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- Reich K, Goodfield M, Green L, Nograles K, Chen R, Levi E, Langley R G B. Efficacy and safety of apremilast through 104 weeks in subjects with moderate to severe psoriasis randomized to placebo, apremilast, or etanercept who continued on or switched to apremilast after week 16 in a phase 3B study. Arthritis and Rheumatology 2017;69(suppl 10)):-.
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- Reich K, Goodfield M, Green L, Nograles K, Chen R, Levi E, Langley R G B. Safety and efficacy of apremilast through 104 weeks in patients with moderate to severe psoriasis who continued on apremilast or switched from etanercept treatment in the liberate study. Annals of the Rheumatic Diseases 2017;76:1325-1326.
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- Reich K, Soung J, Gooderham M, Zhang Z, Nograles K, Day R M, Ferris L, Goodfield M. 52-Week efficacy and safety of apremilast and switch from etanercept in patients with moderate to severe psoriasis: Results from the liberate study. Annals of the Rheumatic Diseases 2016;75:349.
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Revicki 2008 {published data only}
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- Revicki D, Willian M K, Saurat J H, Papp K A, Ortonne J P, Sexton C, Camez A. Impact of adalimumab treatment on health-related quality of life and other patient-reported outcomes: results from a 16-week randomized controlled trial in patients with moderate to severe plaque psoriasis. Br J Dermatol 2008;158(3):549-57. - PubMed
Saurat 2010 {published data only}
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Sheth 2015 {published data only}
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- Sheth P, Mease P J, Li Y, Ganz F, Hojnik M. The majority of patients with moderate to severe psoriatic arthritis had existing structural damage, predisposing them to further progression, which was markedly inhibited by adalimumab. Arthritis and rheumatology 2015;67(Suppl 10):3487-3488.
Sieper 2013 {published and unpublished data}
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Sigurgeirsson 2014 {published data only}
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Strand 2017 {published data only}
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- Strand V, De Vlam K, Covarrubias-Cobos J, Mease P, Gladman D, Hendrikx T, Graham D, Wu J, Chen L. Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis: Results from two phase 3 studies. Journal of the American Academy of Dermatology 2017;76(6):AB109.
Strand 2017a {published data only}
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- Strand V, De Vlam K, Covarrubias-Cobos J A, Mease P J, Gladman D D, Hendrikx T, Kudlacz E, Graham D, Wu J, Cappelleri J C, et al. Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis: results from 2 phase 3 studies. Arthritis & rheumatology 2017;69(Suppl 10):-.
Strand 2019 {published data only}
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- Strand V, Vlam K, Covarrubias-Cobos J A, Mease P J, Gladman D D, Graham D, Wang C, Cappelleri J C, Hendrikx T, Hsu M A. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden-a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs. RMD Open 2019;5(1):e000806. - PMC - PubMed
Strober 2011 {published data only}
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Tyring 2011 {published data only}
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- Tyring S, Kricorian G, Gordon K, Klekotka P. Joint pain improvement in patients on etanercept therapy for moderate to severe psoriasis. Journal of the American Academy of Dermatology 2011;64(2):AB158.
Umezawa 2021 {published and unpublished data}
Van Der Heijde 2017 {published data only}
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- Van Der Heijde D, Gladman D D, Gerald O F, Kavanaugh A, Graham D, Wang C, Fallon L. Tofacitinib treatment in patients with psoriatic arthritis and rates of radiologic progression according to baseline crp levels: Results from a phase 3 clinical study. Arthritis and Rheumatology 2017;69(Suppl 10):-.
Van Der Heijde 2018b {published data only}
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- Van Der Heijde D, Deodhar A, FitzGerald O, Fleischmann R, Gladman D, Gottlieb A B, Coates L C, Hoepken B, Bauer L, Peterson L, et al. Certolizumab pegol provides sustained remission and minimal disease activity in patients with psoriatic arthritis over 4 years' treatment. Annals of the rheumatic diseases 2018;77:1027‐.
Van der Heijde 2019 {published data only}
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Walsh 2017 {published data only}
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Wang 2020 {published data only}
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References to studies awaiting assessment
Ikonomidis 2022 {published data only}
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De Marco 2017 {published data only}
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- 2013-004122-28. An investigator‐initiated double‐blind, parallel‐group randomised controlled trial of GOLimumab and Methotrexate versus Methotrexate in very early PsA using clinical and whole body MRI outcomes: the GOLMePsA study. https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004122-28/GB 2015. - PMC - PubMed
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NCT05071664 {published data only}
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Ogdie 2023 {published and unpublished data}
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