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Meta-Analysis
. 2015 Jul 17;2015(7):CD010952.
doi: 10.1002/14651858.CD010952.pub2.

Non-steroidal anti-inflammatory drugs (NSAIDs) for axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis)

Féline P B Kroon  1 , Lennart R A van der Burg, Sofia Ramiro, Robert B M Landewé, Rachelle Buchbinder, Louise Falzon, Désirée van der Heijde
Affiliations
Meta-Analysis

Non-steroidal anti-inflammatory drugs (NSAIDs) for axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis)

Féline P B Kroon et al. Cochrane Database Syst Rev. .

Abstract

Background: Axial spondyloarthritis (axSpA) comprises ankylosing spondylitis (radiographic axSpA) and non-radiographic (nr-)axSpA and is associated with psoriasis, uveitis and inflammatory bowel disease. Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as first-line drug treatment.

Objectives: To determine the benefits and harms of NSAIDs in axSpA.

Search methods: We searched CENTRAL, MEDLINE and EMBASE to 18 June 2014.

Selection criteria: Randomised controlled trials (RCTs) or quasi-RCTs of NSAIDs versus placebo or any comparator in adults with axSpA and observational cohort studies studying the long term effect (≥ six months) of NSAIDs on radiographic progression or adverse events (AEs). The main comparions were traditional or COX-2 NSAIDs versus placebo. The major outcomes were pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), radiographic progression, number of withdrawals due to AEs and number of serious AEs

Data collection and analysis: Two review authors independently selected trials for inclusion, assessed the risk of bias, extracted data and assessed the quality of evidence for major outcomes using GRADE.

Main results: We included 39 studies (35 RCTs, two quasi-RCTs and two cohort studies); and 29 RCTs and two quasi-RCTs (n = 4356) in quantitative analyses for the comparisons: traditional NSAIDs versus placebo, cyclo-oxygenase-2 (COX-2) versus placebo, COX-2 versus traditional NSAIDs, NSAIDs versus NSAIDs, naproxen versus other NSAIDs, low versus high dose. Most trials were at unclear risk of selection bias (n = 29), although blinding of participants and personnel was adequate in 24 trials. Twenty-five trials had low risk of attrition bias and 29 trials had low risk of reporting bias. Risk of bias in both cohort studies was high for study participation, and low or unclear for all other criteria. No trials in the meta-analyses assessed patients with nr-axSpA.Traditional NSAIDs were more beneficial than placebo at six weeks. High quality evidence (four trials, N=850) indicates better pain relief with NSAIDs (pain in control group ranged from 57 to 64 on a 100mm visual analogue scale (VAS) and was 16.5 points lower in the NSAID group (95% confidence interval (CI) -20.8 to -12.2), lower scores indicate less pain, NNT 4 (3 to 6)); moderate quality evidence (one trial, n = 190) indicates improved disease activity with NSAIDs (BASDAI in control group was 54.7 on a 100-point scale and was 17.5 points lower in the NSAID group, 95% CI -23.1 to -11.8), lower scores indicate less disease activity, NNT 3 (2 to 4)); and high quality evidence (two trials, n = 356) indicates improved function with NSAIDs (BASFI in control group was 50.0 on a 100-point scale and was 9.1 points lower in the NSAID group (95% CI -13.0 to -5.1), lower scores indicate better functioning, NNT 5 (3 to 8)). High (five trials, n = 1165) and moderate (three trials, n = 671) quality evidence (downgraded due to potential imprecision) indicates that withdrawals due to AEs and number of serious AEs did not differ significantly between placebo (52/1000 and 2/1000) and NSAID (39/1000 and 3/1000) groups after 12 weeks (risk ratio (RR) 0.75, 95% CI 0.46 to 1.21; and RR 1.69, 95% CI 0.36 to 7.97, respectively). BASMI and radiographic progression were not reported.COX-2 NSAIDS were also more efficacious than placebo at six weeks. High quality evidence (two trials, n = 349) indicates better pain relief with COX-2 (pain in control group was 64 points and was 21.7 points lower in the COX-2 group (95% CI -35.9 to -7.4), NNT 3 (2 to 24)); moderate quality evidence (one trial, n = 193) indicates improved disease activity with COX-2 (BASDAI in control groups was 54.7 points and was 22 points lower in the COX-2 group (95% CI -27.4 to -16.6), NNT 2 (1 to 3)); and high quality evidence (two trials, n = 349) showed improved function with COX-2 (BASFI in control group was 50.0 points and was 13.4 points lower in the COX-2 group (95% CI -17.4 to -9.5), NNT 3 (2 to 4)). Low and moderate quality evidence (three trials, n = 669) (downgraded due to potential imprecision and heterogeneity) indicates that withdrawals due to AEs and number of serious AEs did not differ significantly between placebo (11/1000 and 2/1000) and COX-2 (24/1000 and 2/1000) groups after 12 weeks (RR 2.14, 95% CI 0.36 to 12.56; and RR 0.92, 95% CI 0.14 to 6.21, respectively). BASMI and radiographic progression were not reported.There were no significant differences in benefits (pain on VAS: MD -2.62, 95% CI -10.99 to 5.75; three trials, n = 669) or harms (withdrawals due to AEs: RR 1.04, 95% CI 0.60 to 1.82; four trials, n = 995) between NSAID classes. While indomethacin use resulted in significantly more AEs (RR 1.25, 95% CI 1.06 to 1.48; 11 studies, n = 1135), and neurological AEs (RR 2.34, 95% CI 1.32 to 4.14; nine trials, n = 963) than other NSAIDs, these findings were not robust to sensitivity analyses. We found no important differences in harms between naproxen and other NSAIDs (three trials, n = 646), although other NSAIDs appeared more effective for relieving pain (MD 6.80, 95% CI 3.72 to 9.88; two trials, n = 232). We found no clear dose-response effect on benefits or harms (five studies, n = 1136). Single studies suggest NSAIDs may be effective in retarding radiographic progression, especially in certain subgroups of patients, e.g. patients with high CRP, and that this may be best achieved by continuous rather than on-demand use of NSAIDs.

Authors' conclusions: High to moderate quality evidence indicates that both traditional and COX-2 NSAIDs are efficacious for treating axSpA, and moderate to low quality evidence indicates harms may not differ from placebo in the short term. Various NSAIDs are equally effective. Continuous NSAID use may reduce radiographic spinal progression, but this requires confirmation.

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Conflict of interest statement

FK was a principal investigator in Kroon 2012. RL was a principal investigator in Kroon 2012 and Wanders 2005. DvdH was a principal investigator in Dougados 2001, Gossec 2005, Kroon 2012, van der Heijde 2005 and Wanders 2005.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias 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.
4
4
Forest plot of comparison 4 NSAID vs NSAID, outcome 4.15 Number of any adverse events, only studies with indomethacin.
5
5
Forest plot of comparison 4 NSAID vs NSAID, outcome 4.17 Adverse events per organ system, only studies with indomethacin.
1.1
1.1. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 1 Pain on VAS.
1.2
1.2. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 2 Withdrawals due to adverse events.
1.3
1.3. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 3 BASDAI.
1.4
1.4. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 4 Patient's global assessment of disease activity.
1.5
1.5. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 5 Duration of morning stiffness.
1.6
1.6. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 6 CRP.
1.7
1.7. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 7 ASAS 20.
1.8
1.8. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 8 ASAS partial remission.
1.9
1.9. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 9 BASFI.
1.10
1.10. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 10 Chest expansion.
1.11
1.11. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 11 Schober's test.
1.12
1.12. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 12 Pain relief ≥ 50%.
1.13
1.13. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 13 Number of any adverse events.
1.14
1.14. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 14 Number of serious adverse events.
1.15
1.15. Analysis
Comparison 1 Traditional NSAID vs Placebo, Outcome 15 Number of adverse events per organ system.
2.1
2.1. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 1 Pain on VAS.
2.2
2.2. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 2 Withdrawals due to adverse events.
2.3
2.3. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 3 BASDAI.
2.4
2.4. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 4 Patient's global assessment of disease activity.
2.5
2.5. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 5 Duration of morning stiffness.
2.6
2.6. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 6 CRP.
2.7
2.7. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 7 ASAS 20.
2.8
2.8. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 8 ASAS partial remission.
2.9
2.9. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 9 BASFI.
2.10
2.10. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 10 Chest expansion.
2.11
2.11. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 11 Schober's test.
2.12
2.12. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 12 Pain relief ≥ 50%.
2.13
2.13. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 13 Number of any adverse events.
2.14
2.14. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 14 Number of serious adverse events.
2.15
2.15. Analysis
Comparison 2 COX‐2 vs Placebo, Outcome 15 Number of adverse events per organ system.
3.1
3.1. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 1 Pain on VAS.
3.2
3.2. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 2 Withdrawals due to adverse events.
3.3
3.3. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 3 BASDAI.
3.4
3.4. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 4 Patient's global assessment of disease activity.
3.5
3.5. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 5 Duration of morning stiffness.
3.6
3.6. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 6 CRP.
3.7
3.7. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 7 ASAS 20.
3.8
3.8. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 8 ASAS partial remission.
3.9
3.9. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 9 BASFI.
3.10
3.10. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 10 BASMI.
3.11
3.11. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 11 Chest expansion.
3.12
3.12. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 12 Schober's test.
3.13
3.13. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 13 Pain relief ≥ 50%.
3.14
3.14. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 14 Number of any adverse events.
3.15
3.15. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 15 Number of serious adverse events.
3.16
3.16. Analysis
Comparison 3 COX‐2 vs traditional NSAID, Outcome 16 Number of adverse events per organ system.
4.1
4.1. Analysis
Comparison 4 NSAID vs NSAID, Outcome 1 Pain on Likert scale.
4.2
4.2. Analysis
Comparison 4 NSAID vs NSAID, Outcome 2 Pain on VAS.
4.3
4.3. Analysis
Comparison 4 NSAID vs NSAID, Outcome 3 Withdrawals due to adverse events.
4.4
4.4. Analysis
Comparison 4 NSAID vs NSAID, Outcome 4 Patient's global assessment of disease activity.
4.5
4.5. Analysis
Comparison 4 NSAID vs NSAID, Outcome 5 Duration of morning stiffness.
4.6
4.6. Analysis
Comparison 4 NSAID vs NSAID, Outcome 6 Severity of morning stiffness.
4.7
4.7. Analysis
Comparison 4 NSAID vs NSAID, Outcome 7 CRP.
4.8
4.8. Analysis
Comparison 4 NSAID vs NSAID, Outcome 8 ESR.
4.9
4.9. Analysis
Comparison 4 NSAID vs NSAID, Outcome 9 Lateral spinal flexion.
4.10
4.10. Analysis
Comparison 4 NSAID vs NSAID, Outcome 10 Chest expansion.
4.11
4.11. Analysis
Comparison 4 NSAID vs NSAID, Outcome 11 Tragus‐to‐wall distance.
4.12
4.12. Analysis
Comparison 4 NSAID vs NSAID, Outcome 12 Occiput‐to‐wall distance.
4.13
4.13. Analysis
Comparison 4 NSAID vs NSAID, Outcome 13 Schober's test.
4.14
4.14. Analysis
Comparison 4 NSAID vs NSAID, Outcome 14 Pain relief ≥ 50%.
4.15
4.15. Analysis
Comparison 4 NSAID vs NSAID, Outcome 15 Number of any adverse events.
4.16
4.16. Analysis
Comparison 4 NSAID vs NSAID, Outcome 16 Number of serious adverse events.
4.17
4.17. Analysis
Comparison 4 NSAID vs NSAID, Outcome 17 Adverse events per organ system.
5.1
5.1. Analysis
Comparison 5 Naproxen vs other NSAID, Outcome 1 Pain on VAS.
5.2
5.2. Analysis
Comparison 5 Naproxen vs other NSAID, Outcome 2 Withdrawals due to adverse events.
5.3
5.3. Analysis
Comparison 5 Naproxen vs other NSAID, Outcome 3 BASDAI.
5.4
5.4. Analysis
Comparison 5 Naproxen vs other NSAID, Outcome 4 Patient's global assessment of disease activity.
5.5
5.5. Analysis
Comparison 5 Naproxen vs other NSAID, Outcome 5 Duration of morning stiffness.
5.6
5.6. Analysis
Comparison 5 Naproxen vs other NSAID, Outcome 6 ASAS 20.
5.7
5.7. Analysis
Comparison 5 Naproxen vs other NSAID, Outcome 7 ASAS partial remission.
5.8
5.8. Analysis
Comparison 5 Naproxen vs other NSAID, Outcome 8 BASFI.
5.9
5.9. Analysis
Comparison 5 Naproxen vs other NSAID, Outcome 9 Schober's test.
5.10
5.10. Analysis
Comparison 5 Naproxen vs other NSAID, Outcome 10 Number of any adverse events.
5.11
5.11. Analysis
Comparison 5 Naproxen vs other NSAID, Outcome 11 Number of serious adverse events.
5.12
5.12. Analysis
Comparison 5 Naproxen vs other NSAID, Outcome 12 Number of adverse events per organ system.
6.1
6.1. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 1 Pain on VAS.
6.2
6.2. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 2 Withdrawals due to adverse events.
6.3
6.3. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 3 BASDAI.
6.4
6.4. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 4 Patient's global assessment of disease activity.
6.5
6.5. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 5 Duration of morning stiffness.
6.6
6.6. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 6 CRP.
6.7
6.7. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 7 ASAS 20.
6.8
6.8. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 8 ASAS partial remission.
6.9
6.9. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 9 BASFI.
6.10
6.10. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 10 BASMI.
6.11
6.11. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 11 Chest expansion.
6.12
6.12. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 12 Schober's test.
6.13
6.13. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 13 Pain relief ≥ 50%.
6.14
6.14. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 14 Number of any adverse events.
6.15
6.15. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 15 Number of serious adverse events.
6.16
6.16. Analysis
Comparison 6 Low dose vs high dose NSAID, Outcome 16 Number of adverse events per organ system.
7.1
7.1. Analysis
Comparison 7 Subgroup analysis: traditional and COX‐2 NSAID vs Placebo, Outcome 1 Pain (VAS).
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD010952

References

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    1. Simpson MR, Simpson NR, Scott BO, Beatty DC. A controlled study of flufenamic acid in ankylosing spondylitis. A preliminary report. Annals of Physical Medicine 1966;Suppl:126‐8. - PubMed
Sydnes 1981 {published data only}
    1. Sydnes OA. Comparison of piroxicam with indomethacin in ankylosing spondylitis: a double‐blind crossover trial. British Journal of Clinical Practice 1981;35(1):40‐4. - PubMed
Tannenbaum 1984 {published data only}
    1. Tannenbaum H, DeCoteau WE, Esdaile JM. A double blind multicenter trial comparing piroxicam and indomethacin in ankylosing spondylitis with long‐term follow‐up. Current Therapeutic Research ‐ Clinical and Experimental 1984;36(3):426‐35.
van der Heijde 2005 {published and unpublished data}
    1. Gossec L, Heijde D, Meilian A, Krupa DA, James MK, Cavanaugh PF, et al. Efficacy of cyclo‐oxygenase‐2 inhibition by etoricoxib and naproxen on the axial manifestations of ankylosing spondylitis in the presence of peripheral arthritis. Annals of the Rheumatic Diseases 2005;64(11):1563‐7. - PMC - PubMed
    1. Heijde D, Baraf HSB, Ramos‐Remus C, Calin A, Weaver AL, Schiff M, et al. Evaluation of the efficacy of etoricoxib in ankylosing spondylitis: results of a fifty‐two‐week, randomized, controlled study. Arthritis and Rheumatism 2005;52(4):1205‐15. - PubMed
Villa Alcázar 1996 {published data only}
    1. Villa Alcázar LF, Buergo M, Rico Lenza H, Montull Fruitós E. Aceclofenac is as safe and effective as tenoxicam in the treatment of ankylosing spondylitis: a 3 month multicenter comparative trial. Journal of Rheumatology 1996;23(7):1194‐9. - PubMed
Wanders 2005 {published and unpublished data}
    1. Kroon F, Landewé R, Dougados M, Heijde D. Continuous NSAID use reverts the effects of inflammation on radiographic progression in patients with ankylosing spondylitis. Annals of the Rheumatic Diseases 2012;71(10):1623‐9. - PubMed
    1. Wanders A, Heijde D, Landewé R, Béhier JM, Calin A, Olivieri I, et al. Nonsteroidal antiinflammatory drugs reduce radiographic progression in patients with ankylosing spondylitis: a randomized clinical trial. Arthritis and Rheumatism 2005;52(6):1756‐65. - PubMed

References to studies excluded from this review

Armstrong 1984 {published data only}
    1. Amstrong RD, Laurent R, Panayi GS. A comparison of indoprofen and indomethacin in the treatment of ankylosing spondylitis. Pharmatherapeutica 1984;3(10):637‐41. - PubMed
Bird 1980 {published data only}
    1. Bird HA, Rhind VM, Pickup ME, Wright V. A comparative study of benoxaprofen and indomethacin in ankylosing spondylitis. Journal of Rheumatology. Supplement 1980;6:139‐42. - PubMed
Burry 1980 {published data only}
    1. Burry HC, Siebers R. A comparison of flurbiprofen with naproxen in ankylosing spondylitis. New Zealand Medical Journal 1980;92(670):309‐11. - PubMed
Byron 1982 {published data only}
    1. Byron MA, Steele CE. A double‐blind crossover study comparing tolmetin sodium and naproxen in the treatment of ankylosing spondylitis. Current Medical Research and Opinion 1982;7:670‐6.
Calin 1974 {published data only}
    1. Calin A, Grahame R. Double‐bind cross‐over trial of flurbiprofen and phenylbutazone in ankylosing spondylitis. British Medical Journal 1974;4(5943):496‐9. - PMC - PubMed
Charlot 1982 {published data only}
    1. Charlot J, Villiaumey J. A comparative study of benoxaprofen and ketoprofen in ankylosing spondylitis. European Journal of Rheumatology and Inflammation 1982;5(2):277‐81. - PubMed
Dougados 1989 {published data only}
    1. Dougados M, Caporal R, Doury P, Thiesce A, Pattin S, Laffez B, et al. A double blind crossover placebo controlled trial of ximoprofen in as. Journal of Rheumatology 1989;16(8):1167‐9. - PubMed
Doury 1986 {published data only}
    1. Doury P, Roux H. Isoxicam vs ketoprofen in ankylosing spondylitis. British Journal of Clinical Pharmacology 1986;22(Suppl 2):157S‐60S. - PMC - PubMed
Esdaile 1982 {published data only}
    1. Esdaile J, Rothwell R, MacLaughlin K, Percy J, Hawkins D. Double‐blind comparison of tolmetin sodium and indomethacin in ankylosing spondylitis. Journal of Rheumatology 1982;9(1):69‐74. - PubMed
Gibson 1980 {published data only}
    1. Gibson T, Laurent R. Sulindac and indomethacin in the treatment of ankylosing spondylitis: a double‐blind cross‐over study. Rheumatology and Rehabilitation 1980;19(3):189‐92. - PubMed
Harkness 1977 {published data only}
    1. Harkness AJ, Burry HC, Grahame R. A trial of feprazone in ankylosing spondylitis. Rheumatology and Rehabilitation 1977;16(3):158‐61. - PubMed
Johnson 1992 {published data only}
    1. Johnsen V, Brun JG, Fjeld E, Hansen K, Sydnes OA, Ugstad MB. Morning stiffness and nightime pain in ankylosing spondylitis. A comparison between enteric‐coated and plain naproxen tablets. European Journal of Rheumatology & Inflammation 1992;12(2):37‐42. - PubMed
Kennedy 1991 {published data only}
    1. Kennedy AC, Germain BF, Goldman AL, Vreede PD. A double‐blind, crossover comparison of ketoprofen and indomethacin in ankylosing spondylitis. Advances in Therapy 1991;8(3):148‐56.
Kinsella 1967 {published data only}
    1. Kinsella TD, MacKenzie KR, Kim SO, Johnson LG. Evaluation of indomethacin by a controlled, cross‐over technique in 30 patients with ankylosing spondylitis. Canadian Medical Association Journal 1967;96(22):1454‐9. - PMC - PubMed
Mayrhofer 1990 {published data only}
    1. Mayrhofer F, Broll H, Eberl R, Ebner W, Klein G, Rainer F, et al. Tenoxicam versus diclofenac in patients with ankylosing spondylitis. A double‐blind study. Drug Investigation 1990;2(Suppl 3):52‐3.
Peloso 2011 {published data only}
    1. Peloso PM, Gammaitoni A, Smugar SS, Wang H, Moore AR. Longitudinal numbers‐needed‐to‐treat (NNT) for achieving various levels of analgesic response and improvement with etoricoxib, naproxen, and placebo in ankylosing spondylitis. BMC Musculoskeletal Disorders 2011;12:165. - PMC - PubMed
Peter 1975 {published data only}
    1. Peter E. A double blind comparison of naproxen and indomethacin on the after‐midnight‐pain of patients with morbus bechterew [Wirkungsvergleich von Naproxen und Indometacin im Doppelblindversuch beim Nachmitternachtsschmerz von Morbus Bechterew]. Arzneimittel‐Forschung 1975;25(2A):324‐5. - PubMed
Sadowska‐Wroblewska 1980 {published data only}
    1. Sadowska‐Wroblewska M, Garwolinska H, Filipovicz‐Sosnowska A. Azapropazone versus indomethacin in a double blind test with patients with ankylosing spondylitis [Azapropazon Versus Indometacin im Doppelblindversuch bei Patienten mit Spondylitis ankylosans]. Zeitschrift für Rheumatologie 1980;39(11‐2):406‐11. - PubMed
Schattenkirchner 1980 {published data only}
    1. Schattenkirchner M, Müller‐Fassbender H, Melzer H. An open long‐term study of piroxicam in ankylosing spondylitis patients [Eine offene Langzeitstudie mit Piroxicam bei Patienten mit Spondylitis ankylosans (M. Marie‐Strümpell, M.Bechterew)]. Aktuelle Rheumatologie 1980;5:38‐42.
Shipley 1980 {published data only}
    1. Shipley M, Berry H, Bloom B. A double‐blind cross‐over trial of indomethacin, fenoprofen and placebo in ankylosing spondylitis, with comments on patient assessment. Rheumatology and Rehabilitation 1980;19(2):122‐5. - PubMed
Sieper 2014 {published data only}
    1. Sieper J, Lenaerts J, Wollenhaupt J, Rudwaleit M, Mazurov VI, Myasoutova L, et al. Maintenance of biologic‐free remission with naproxen or no treatment in patients with early, active axial spondyloarthritis: results from a 6‐month, randomised, open‐label follow‐up study, INFAST Part 2. Annals of the Rheumatic Diseases 2014;73(1):108‐13. - PMC - PubMed
Simpson 1968 {published data only}
    1. Simpson MR, Simpson NR, Masheter HC. A controlled study of flufenamic acid in ankylosing spondylitis. A final report and follow‐up study. Annals of Physical Medicine 1968;9(6):229‐33. - PubMed
Sturrock 1974 {published data only}
    1. Sturrock RD, Hart FD. Double‐blind cross‐over comparison of indomethacin, flurbiprofen, and placebo in ankylosing spondylitis. Annals of the Rheumatic Diseases 1974;33(2):129‐31. - PMC - PubMed
Thompson 1977 {published data only}
    1. Thompson M, Akyol MS. A controlled comparative trial of Butacote and fenclofenac in the treatment of ankylosing spondylitis. Journal of International Medical Research 1977;5(Suppl 2):96‐9. - PubMed
Van Gerwen 1978 {published data only}
    1. Gerwen F, Korst JK, Gribnau FW. Double‐blind trial of naproxen and phenylbutazone in ankylosing spondylitis. Annals of the Rheumatic Diseases 1978;37(1):85‐8. - PMC - PubMed
Wasner 1981 {published data only}
    1. Wasner C, Britton MC, Kraines RG, Kaye RL, Bobrove AM, Fries JF. Nonsteroidal anti‐inflammatory agents in rheumatoid arthritis and ankylosing spondylitis. JAMA 1981;246(19):2168‐72. - PubMed
Wordsworth 1980 {published data only}
    1. Wordsworth BP, Ebringer RW, Coggins E, Smith S. A double‐blind cross‐over trial of fenoprofen and phenylbutazone in ankylosing spondylitis. Rheumatology and Rehabilitation 1980;19(4):260‐3. - PubMed

References to studies awaiting assessment

1966 {published data only}
    1. Unknown. A nonsteroidal anti‐inflammatory agent. Indomethacin (indocin). JAMA 1966;196(7):651‐2. - PubMed
Acqaviva 1983 {published data only}
    1. Acqaviva B, Cayla J, Delcambre B, Goff P, Loyau G, Serratrice G, et al. Clinical study of Bi‐Profenid in rheumatologic practice [French]. La Semaine des Hôpitaux 1983;59(46):3229‐34. - PubMed
Aeidler 1975 {published data only}
    1. Aeidler H. Clinical results of a multicentral double‐blind examination of naproxen compared to indomethacin in chronic rheumatoid arthritis, ankylosing spondylitis, and osteoarthrosis [German]. Arzneimittel‐Forschung 1975;25(2A):315‐8. - PubMed
Bachmann 1984 {published data only}
    1. Bachmann F. Comparison between sustained release formulations of ibuprofen and indomethacin in treatment of ankylosing spondylitis [Zur Medikamentösen Therapie der Ankylosierenden Spondylitis mit Ibuprofen (Dolgit Retard) im Vergleich zu Indometacin Retard]. Therapiewoche 1984;34:4958‐64.
Baerwald 1999 {published data only}
    1. Baerwald CH, Willeke A, Lies S, Goebel KM, Engel HJ. Efficacy and tolerance of oral hydrolytic enzymes in ankylosing spondylitis as compared with indomethacin: A controlled double‐blind prospective clinical trial. Journal of Clinical Research 1999;2:17‐34.
Becvar 1949 {published data only}
    1. Becvar R, Pavelka K Jr. Ethophenamate injections in treatment of acute painful conditions in rheumatic diseases. Ceska Revmatologie 1994:79‐81.
Beltrán Gutiérrez 1968 {published data only}
    1. Beltrán Gutiérrez J, Fernández del Vallado P, Gijón Baños J. Double‐blind study using flufenamic acid (F.I. 440) and oxyphenylbutazone in rheumatoid arthritis and ankylosing spine. Revista Española de Reumatismo y Enfermedades Osteo‐Articulares 1968;12:219‐21. - PubMed
Bernstein 1992 {published data only}
    1. Bernstein RM, Calin HJ, Ollier S, Calin A. A comparison of the efficacy and tolerability of lornoxicam and indomethacin in ankylosing spondylitis. European Journal of Rheumatology and Inflammation 1992;12:6‐13.
Bird 1986 {published data only}
    1. Bird HA, Gallez P, Astbury C, Looi D, Wright V. A parallel group comparison of tenoxicam and piroxicam in patients with ankylosing spondylitis. Pharmatherapeutica 1986;4(7):457‐62. - PubMed
Bocci 1972 {published data only}
    1. Bocci U, Bignotti N, Luzi T, Pigani G, Santis AM. Controlled clinical study of the therapeutic activity and side‐effects of a preparation of indomethacin in lactocomplex [Italian]. Reumatismo 1972;24(1):1‐9. - PubMed
Burdeĭnĭ 1981 {published data only}
    1. Burdeinyi AP. Double‐blind trial of the therapeutic efficacy of voltaren and indomethacin in Bechterew's disease. Terapevticheskii Arkhiv 1981;53(7):107‐11. - PubMed
    1. Burdeĭnĭ AP. Double blind trial of voltaren and indomethacin in Bechterew's disease [Russian]. Terapevticheskiĭ Arkhiv 1981;53(7):107‐11. - PubMed
Dougados 2000 {published data only}
    1. Dougados M, Calin A, Zeidler H. Double‐blind, placebo‐controlled clinical study over 52 weeks on M. Bechterew patients with 20 mg Piroxicam, 15 mg and 22,5 mg Meloxicam. Zeitschrift für Rheumatologie 2000;59(Suppl 3):49.
Droste 1979 {published data only}
    1. Droste U. Tolmetin 400 mg capsules in treatment of ankylosing spondylitis [Tolectin (Tolmetin) 400 Mg Kapseln in Der Behandlung Der Spondylitis Ankylosans]. Therapiewoche 1979;29:8901‐2.
Droste 1985 {published data only}
    1. Droste U. Pirprofen in the treatment of ankylosing spondylitis. A 3‐week open trial [German]. Fortschritte der Medizin 1985;103:173‐5. - PubMed
Dutu 1982 {published data only}
    1. Dutu A, Bolosiu HD, Parasca I. Treatment with tolmetin in ankylosing spondylitis. Comparative cross‐study with phenylbutazone. Clujul Medical 1982;55:115‐8.
Franke 1975 {published data only}
    1. Franke M, Manz G. Bumadizone‐calcium‐semihydrate (Eumotol) and oxyphenbutazone in the treatment of ankylosing spondylitis. A clinical double‐blind study [German]. Die Medizinische Welt 1975;26(27‐8):1335‐40. - PubMed
Jajic 1982 {published data only}
    1. Jajic I, Nekora A, Chadri HA. Pirprofen, indomethacin and placebo in ankylosing spondylitis. Double‐blind comparison [French]. La Nouvelle Presse Médicale 1982;11(33):2491‐3. - PubMed
Leng Levy 1963 {published data only}
    1. Leng Levy J, David Chausse J, David Chausse F. Clinical results of tanderil administration in gout and rheumatic pelvispondylitis [French]. Journal de Médecine de Bordeaux et du Sud‐Ouest 1963;140:1679‐86. - PubMed
Maier‐Lenz 1981 {published data only}
    1. Maier‐Lenz H, Ringwelski L. Results of a controlled double‐blind comparison of Exrheudon and phenylbutazone [Ergebnisse Einer Kontrollierten Doppelblindstudie mit Exrheudon Versus Phenylbutazon]. Therapiewoche 1981;31:1226‐34.
Mayrhofer 1991 {published data only}
    1. Mayrhofer H, Aglas F, Broll H, Eberl R, Ebner W, Klein G, et al. The efficacy and tolerance of NSAIDs in patients with ankylosing spondylitis. Therapiewoche Osterreich 1991;6:121‐31.
Mertz 1981 {published data only}
    1. Mertz DP. Efficacy and tolerance of proquazone in ankylosing spondylarthritis [Wirkung und Vertraglichkeit von Proquazon bei Spondylitis Ankylosans]. Therapiewoche 1981;31:3274‐8.
Müller‐Fassbender 1979 {published data only}
    1. Müller‐Fassbender H. Tolmetin treatment for ankylosing spondylitis [Behandlung der Spondylitis Ankylosans mit Tolectin® (Tolmetin)]. Therapiewoche 1979;29:8899‐900.
Müller‐Fassbender 1981 {published data only}
    1. Müller‐Fassbender H. Treatment of ankylosing spondylitis with tolmetin in doses of 800 or 1200 mg [Behandlung der Spondylitis Ankylosans mit Tolectin in Einer Dosierung von 800 mg Bzw, 1200 mg]. Verhandlungen der Deutschen Gesellschaft für Rheumatologie 1981;7:335‐7.
Orozco Medina 1983 {published data only}
    1. Orozco Medina JH. Evaluation of efficacy and tolerance of oral indoprofen in patients with ankylosing spondylitis [Valoracion de la eficacia y tolerancia de indoprofen oral en pacientes con espondilitis anquilosante]. Investigación Médica Internacional 1983;10(1):66‐9.
Pattin 1990 {published data only}
    1. Pattin S. Ankylosing spondylitis: efficacy, safety and therapeutic benefit of etodolac (600 mg daily) versus piroxicam (20 mg daily) [Spondylarthrite ankylosante: efficacité, tolérance et beneficé thérapeutique comparés de l'etodolac (600 mg/j) et du piroxicam (20 mg/j)]. Rhumatologie 1990;42(7A):207‐12.
Reiter 1984 {published data only}
    1. Reiter W, Pilger A. Ankylosing spondylitis: comparison of acemetacin and piroxicam. Therapiewoche 1984;34:7209‐15.
Renier 1982 {published data only}
    1. Renier JC, Fournier M, Loyau G, Roux H. Ankylosing spondylitis. Comparative trial of two non‐steroidal anti‐inflammatory agents: pirprofen and ketoprofen [French]. La Nouvelle Presse Médicale 1982;11(33):2494‐6. - PubMed
Schattenkirchner 1981 {published data only}
    1. Schattenkirchner M. Long‐time results of Felden (piroxicam) in ankylosing spondylitis [Langzeiterfahrungen mit Felden (Piroxicam) bei Spondylitis Ankylosans (M. Bechterew)]. Therapiewoche 1981;31:2979‐81.
Schattenkirchner 1986 {published data only}
    1. Schattenkirchner M, Kellerer G, Kruger K. Treatment of ankylosing spondylitis: Single‐blind crossover comparison of acemetacin and diclofenac [Behandlung der Spondylitis Ankylosans: Einfachblinde Cross‐over‐Vergleichsstudie mit Acemetacin und Diclofenac]. Therapiewoche 1986;36:5276‐83.
Simon 1987 {published data only}
    1. Simon L, Bennet P. A comparative study of pirprofene and phenylbutazone in the treatment of ankylosing spondylitis [Etude comparative du pirprofene et de la phenylbutazone dans la spondylarthrite ankylosante]. Rheumatologie 1987;39(9):283‐7.
Stollenwerk 1985 {published data only}
    1. Stollenwerk R, Criegern T, Gierend M, Schilling F. Comparative study of the treatment of ankylosing spondylitis with piroxicam suppositories and indomethacin suppositories in combination with indomethacin retard capsules [Therapee der Spondylitis Ankylosans. Kurzzeitanwendung von Piroxicam‐Suppositorien oder Indometacin‐Suppositorien und ‐Retardkapseln]. Fortschritte der Medizin 1985;103(20):561‐5. - PubMed

References to ongoing studies

ClinicalTrials.gov 2014a {unpublished data only}
    1. NCT01934933. Delaying Ossification and Improving Inflammation of Celebrex Plus/or Enbrel Treatment on Active Ankylosing Spondylitis. http://clinicaltrials.gov/ct2/show/NCT01934933?type=Intr&cond=Spondy... (accessed 18 June 2014).
ClinicalTrials.gov 2014b {unpublished data only}
    1. NCT02089529. Treatment of Axial Spondyloarthritis With Reduced Doses of NSAIDs. http://clinicaltrials.gov/ct2/show/NCT02089529?type=Intr&cond=Spondy... (accessed 18 June 2014).

Additional references

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References to other published versions of this review

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