Eleven trials treated a total of 895 patients, 469 receiving SSZ and 426 placebo. Abstract. The use of methotrexate is based largely on efficacy data from other subtypes of juvenile idiopathic arthritis as … the higher score the more severe disease) Show forest plot, 29 Spondylitis articular index (0‐90, the higher score the more severe disease) Show forest plot, 30 Spondylitis articular index (2nd analysis) (0‐90, the higher score the more severe disease) Show forest plot, 31 Improvement in patient global assessement Show forest plot, 32 Patient assessment of disease severity (end point) (VAS‐100mm, 0=very good, 100= very poor,) Show forest plot, 33 General well‐being (end point) (VAS‐100mm, 0=very good, 100=very poor) Show forest plot, 34 Improvement in physician global assessment Show forest plot, 35 Respond to treatment (based on both patient and physician assessment) Show forest plot, 36 Duration of morning stiffness (hr) Show forest plot, 37 Duration of morning stiffness (2nd analysis) (hr) Show forest plot, 38 Morning stiffness (end point) (VAS‐100mm, 0=no stiffness, 100=severe) Show forest plot, 39 Improvement in morning stiffness Show forest plot, 41 ESR (2nd analysis) (mm/hr) Show forest plot, 43 CRP (2nd analysis) (ug/ml) Show forest plot, 44 withdrawal for side effect Show forest plot, 45 Withdrawal for ineffectiveness Show forest plot, 46 Drop‐out for any reason Show forest plot, 1 Back pain (VAS‐100mm, 0=no pain, 100=severe) Show forest plot, 2 Score of sleep disturbance (0‐4, 0=no disturbance, 4=severe disturbance) Show forest plot, 5 Fingers‐to‐floor test (cm) Show forest plot, 6 Articular index (0‐66, the higher score the more severe disease) Show forest plot, 7 Degree of joint swelling (0‐66, the higher score the more severe disease) Show forest plot, 8 Patient assessment of disease severity (VAS‐100mm, 0=very good, 100=very poor) Show forest plot, 9 Duration of morning stiffness (hr) Show forest plot, 1 Back pain (VAS‐100mm, 0 as no pain, 100 severe) Show forest plot, 6 Patient assessment of disease severity (VAS‐100mm, 0=very good, 100=very poor) Show forest plot, 7 Duration of morning stiffness (hr) Show forest plot. Pooled data showed a similar result. Comparison 1 SSZ vs placebo, Outcome 9 Score of daily NSAIDs (change from baseline, usual dosage as 10). Comparison 1 SSZ vs placebo, Outcome 6 Night pain (not bother). People with early ankylosing spondylitis, with active disease or peripheral arthritis may improve with sulfasalazine. Disagreements on the inclusion of the studies were resolved, where necessary, by recourse to a third reviewer. To answer this question, scientists found and analyzed 11 research studies. 3. Besides, both trials indicated that patients with peripheral arthritis might benefit from SSZ. Methods: 1. was the study described as randomised? Epub 2020 Sep 14. Sulfasalazine for ankylosing spondylitis. One study (Benitez‐Del‐Castillo) did not assess relevant outcomes for the present review. Clinical management of the most common extra-intestinal manifestations in patients with inflammatory bowel disease focused on the joints, skin and eyes. Three trials (Clegg 1996, Nissila 1988, Schmidt 2002) assessed CRP and only one (Schmidt 2002) showed significant difference between intervention groups, favouring SSZ over placebo. Seven of them (Clegg 1999, Dougados 1987, Dougados 1990, Nissila 1994, Reda 1995, Schmidt 2000, Taggart 1995) were duplicate publications. Comparison 1 SSZ vs placebo, Outcome 17 Occiput‐to‐wall test (2nd analysis) (cm). In the Clegg 1996 study, the only presented outcome was response rate, which summarized patient self‐assessment, physician assessment, back pain, duration of morning stiffness, joint pain/tenderness score (for patients with peripheral arthritis) and joint swelling score (for patients with peripheral arthritis). Efficacy of sulfasalazine in patients with inflammatory back pain due to undifferentiated spondyloarthritis and early ankylosing spondylitis: a multicentre randomised controlled trial. Comparison 1 SSZ vs placebo, Outcome 29 Spondylitis articular index (0‐90, the higher score the more severe disease). Gold: At least one randomised clinical trial meeting all of the following criteria for the major outcome(s) as reported: Handling of withdrawals > 80% follow up (imputations based on methods such as LOCF are acceptable). A similar conclusion could be drawn from the DMARD management in RA where DMARD was recommended to be initiated within 3 months after diagnosis (ACR 2002). The proportion of drop‐out was 19.3%. For EMBASE (Ovid), the search strategy is in Appendix 2. Primary outcomes Three trials (Dougados 1986, Nissila 1988, Schmidt 2002) showed statistically significant differences between treatment groups (Additional Table 01). Comparison 1 SSZ vs placebo, Outcome 18 Fingers‐to‐floor test (cm). Silver: A systematic review or randomised trial that does not meet the above criteria. Improvements in movement of the spine, pain, function (physical ability) and overall‐well being was about the same whether people took sulfasalazine or fake pills. 1,2. Significantly more withdrawals for side effects (RR 1.50, 95% CI 1.04 to 2.15, NNH 23, 95% CI 10 to 288) and for any reason (RR 1.33, 95% CI 1.03 to 1.73, NNH 17, 95% CI 8 to 180) were found in SSZ compared with placebo group although severe side effects were rare (1 of the 469 patients taking SSZ). More people stopped taking sulfasalazine because of the side effects than when taking fake pills. A randomised trial with a 'head‐to‐head' comparison of agents would be considered silver level ranking unless a reference were provided to a comparison of one of the agents to placebo showing at least a 20% relative difference. Therefore, these pooled data should not be the sole basis for conclusion and scrutiny of individual studies is also important (see Additional Table 01). Current guidelines suggest sulfasalazine (SSZ) treatment as initial therapy for the … People were either given sulfasalazine at 2‐3 g per day or were in another group that had a fake pill for 12 weeks to 3 years. Comparison 1 SSZ vs placebo, Outcome 11 Chest expansion (cm). Patients with IBP and no peripheral arthritis had significantly (p = 0.03) more benefit with SSZ (BASDAI 5.1 (1.3) to 2.8 (2.3)) than with placebo (5.2 (1.6) to 3.8 (2.4)). Ther Adv Musculoskelet Dis. Spondylitis Association of America (SAA) is a national, non-profit organization, dedicated to being a leader in the quest to cure ankylosing spondylitis and related diseases, and to empower those affected to live life to the fullest. Five studies (Davis 1989, Dougados 1986, Feltelius 1986, Krajnc 1990, Nissila 1988) reported that SSZ was beneficial. These two trials confirmed that SSZ showed benefit in reducing ESR but not in other outcomes. Can M, Aydın SZ, Niğdelioğlu A, Atagündüz P, Direskeneli H. Int J Rheum Dis. Sensitivity analysis, however, found no obvious difference between selection and deselection of this trial in the pooled result. Comparison 1 SSZ vs placebo, Outcome 3 Improvement in back pain. 5. Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 7 Duration of morning stiffness (hr). Depending on the trial, age and duration of disease was reported as a mean or median value. Therefore, it is necessary to verify the efficacy of SSZ in the treatment of AS. Ankylosing spondylitis (type of arthritis affecting the spine) has been reported by people with ankylosing spondylitis, rheumatoid arthritis, pain, high blood pressure, osteoporosis. There was significant heterogeneity among the trials (p<0.0001) ((Comparison 01.12). Our site uses cookies to improve your experience. Handling of withdrawals >80% follow up (imputations based on methods such as Last Observation Carried Forward (LOCF) are acceptable). WMD was ‐13.89 and 95% CI ‐22.54 to ‐5.24 (Comparison 01.38). Disagreements on the inclusion of the studies were resolved, where necessary, by recourse to a third reviewer. The outcomes in continuous data were presented as either end point values or change from baseline or both. For ESR and morning stiffness outcome, both absolute and relative benefit from SSZ was calculated (Additional table 2). 7. were the results analysed according to intention‐to‐treat? 5. was the outcome assessment blinded? What is the bottom line? We included the following comparisons: 1. sulfasalazine versus placebo 2. sulfasalazine versus other medication 3. sulfasalazine versus no medication, According to the core set for the evaluation of disease controlling antirheumatic treatment (DC‐ART) proposed by Assessment of Ankylosing Spondylitis (ASAS) Working Group (van der Heijde 1999, van der Heijde 2002), we included the following primary and secondary outcomes: The primary outcomes: 1. physical function 2. pain 3. spinal mobility 4. peripheral joints/entheses (pain, swelling and tender) 5. changes in spine radiograph 6. patient and physician global assessment The secondary outcomes: 1. changes in hip radiograph 2. spinal stiffness 3. fatigue 4. level of acute phase reactants, including erythrocyte sedimentation rate (ESR) and C‐reactive protein (CRP), For the assessment of adverse effects related to sulfasalazine, we included: 1. any side effects reported in the included studies 2. toxicity‐related withdrawals 3. total number of withdrawals and dropouts. Here peripheral response was composition of 4 parameters, eg patient self‐assessment, physician assessment, joint pain/tenderness score and joint swelling score. 2. In addition, many trials used patient's subjective assessment as markers, eg duration of morning stiffness, pain severity which is liable to investigators' intention. Secondary outcomes included measures of spinal pain, physical function and inflammation. All the dichotomous data presented in Table comparisons and data were according to intention‐to‐treat analysis. Comparison 2 SSZ vs placebo (AS with peripheral arthritis, end point values), Outcome 5 Fingers‐to‐floor test (cm). In the Schmidt 2002 trial, the differences in back pain VAS‐100 mm (WMD ‐2.30, 95% CI ‐4.44 to ‐0.16) (Comparison 01.04,05), chest expansion (WMD 0.30 cm, 95% CI 0.16 to 0.44 cm) (Comparison 01.11,12) and Schober's test (WMD 0.50 cm, 95% CI 0.44 to 0.56 cm) (Comparison 01.14,15) were found to be statistically significant, favouring SSZ over placebo. A systematic review of randomized controlled trials. None of these studies used ASAS improvement criteria for AS (Anderson 2001, Brandt 2004), simply because all these studies were conducted before the criteria were published. Comparison 1 SSZ vs placebo, Outcome 43 CRP (2nd analysis) (ug/ml). Ther Adv Musculoskelet Dis. 3. Comparison 1 SSZ vs placebo, Outcome 42 CRP (ug/ml). But when NSAIDs are not working well disease modifying anti‐rheumatic drugs (DMARDs), such as sulfasalazine may be used. When deselected, the difference and heterogeneity were insignificant. If you have a Wiley Online Library institutional username and password, enter them here. Four studies (Dougados 1986, Feltelius 1986, Kirwan 1993, Schmidt 2002) had more than 20% and two (Kirwan 1993, Schmidt 2002) had more than 30% of patients dropping out. Braun J, Zochling J, Baraliakos X, et al. Thirteen studies were excluded from the review. Comparison 2 SSZ vs placebo (AS with peripheral arthritis, end point values), Outcome 3 Chest expansion (cm). Clegg 1996 was one of them. The pooled analysis showed that the difference between intervention groups was significant only in erythrocyte sedimentation rate (ESR) (WMD ‐4.79, 95% CI ‐8.80 to ‐0.78) mm/h) and morning stiffness VAS‐100 mm (visual analogue scale 100 mm, where 0 = no stiffness and 100 = severe) (WMD ‐13.89, 95% CI ‐22.54 to ‐5.24), favouring SSZ over placebo. Difference of selection criteria is likely one reason why SSZ demonstrated benefit in some trials but not in others. The efficacy of SSZ in AS has been controversial for decades. Only one study (Winkler 1989) presented data of subgroups (patients with and without peripheral arthritis). By continuing to browse this site you agree to us using cookies as described in About Cookies. More than 30 outcomes were assessed. Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 2 Score of sleep disturbance (0‐4, 0=no disturbance, 4=severe disturbance). The primary outcome variable was the change in BASDAI over 6 months. Secondary outcomes Five trials (Clegg 1996, Krajnc 1990, Nissila 1988, Schmidt 2002, Winkler 1989) assessed duration of morning stiffness. Female participants accounted for 14%, much lower than that in the prevalence reported of 20‐35% (Sieper 2002b). It is the best studied DMARD used in AS, but its efficacy remains unclear. Schmidt 2002 found a statistically significant difference between intervention groups, favouring SSZ over placebo. Objective: Etanercept, a fully human tumor necrosis factor (TNF) receptor, is an effective treatment in patients with ankylosing spondylitis (AS). Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 5 Fingers‐to‐floor test (cm). It is not clear whether it … The proportion of patients with peripheral arthritis was the highest at 68% (it ranged from 66% to 0 in other trials). 4. In 1990, Ferraz (Ferraz 1990) conducted a meta‐analysis of five trials (Corkill 1990, Davis 1989, Dougados 1986, Feltelius 1986, Nissila 1988) treating a total of 272 AS patients and found that the pooled estimate of clinical benefit significantly favoured SSZ over placebo in duration and severity of morning stiffness, severity of pain, general well being and ESR. Among them 30.3% dropped out. Select your preferred language for Cochrane Reviews. Side effects occur in some people and include stomach upset, skin rashes and mouth sores which may occasionally stop people from taking sulfasalazine. Another study (Clegg 1996) has separately analyzed the results of patients with peripheral arthritis (n = 77) and found more peripheral responses in SSZ than in placebo group (55.9% vs 30.2%, P = 0.023). Mean Difference (IV, Random, 95% CI), 22 Joint pain/tenderness score (2nd analysis) (0‐198, the higher score the more severe disease) Show forest plot, 23 Joint swelling score (0‐198, the higher score the more severe disease) or number Show forest plot, 24 Joint swelling score (2nd analysis) (0‐198, the higher score the more severe disease) Show forest plot, 25 Dactylitis score (0‐3, 0=normal, 3=severe) Show forest plot, 26 Dactylitis score (2nd analysis) (0‐3, 0=normal, 3=severe) Show forest plot, 27 Enthesopathy index (0‐90, 0‐66, 0‐90? For pooled data, only chest expansion showed significant difference between intervention groups, favouring SSZ over placebo. Does sulfasalazine work to treat ankylosing spondylitis and how safe is it? Arthritis Rheum. This has to be examined further by separately analysing patients with peripheral arthritis. In the present review, we added six other trials and increased the number of participant to 895. Among 469 patients taking SSZ, one was reported to develop a severe skin reaction in Clegg 1996. 230 patients (50% men, age range 18-64 years, 67% human leucocyte antigen B27 positive) were treated with either SSZ 2x1 g/day or placebo for 6 months. Arthritis Rheum 47 (2002): 234-41. Excludes data and analyses, and appendices, SSZ vs placebo (AS with peripheral arthritis, end point values), SSZ vs placebo (axial form AS, end point values), https://doi.org/10.1002/14651858.CD004800.pub2, Individual access - via Wiley Online Library, data are only available for Cochrane Reviews that contain one or more forest plots; and. The primary objective of this study is to evaluate the efficacy of safety of etanercept dose reduction combined with sulfasalazine in ankylosing spondylitis (AS) patients who have achieved a significant … Comparison 1 SSZ vs placebo, Outcome 5 Back pain (2nd analysis) (VAS‐100mm, 0=no pain, 100=severe). Sulfasalazine reduces spinal stiffness, peripheral arthritis, and the erythrocyte sedimentation rate (ESR), but there is no evidence that it improves spinal mobility, enthesitis, or … the higher score the more severe disease). To assess the effect of sulfasalazine (SSZ) on inflammatory back pain (IBP) due to active undifferentiated spondyloarthritis (uSpA) or ankylosing spondylitis in patients with symptom duration <5 years. The mean (SD) BASDAI dropped markedly in both groups: by 3.7 (2.7) and 3.8 (2.4), respectively, as did most secondary outcome measures. The data available are protected by copyright and may only be used in accordance with the Terms and Conditions. In the present review, all trials selected patients with active disease but the definition was quite different among the trials. Among 469 patients receiving SSZ, severe adverse reaction was reported in one patient who developed a generalized, erythematous, raised, pruritic eruption which was associated nausea, anorexia and insomnia (Clegg 1996). More than 30 outcomes were assessed, covering physical function which comprised some twenty activities and the level of performance was rated (Comparison 01.1,2), pain (3‐10), spinal mobility (11‐20), peripheral joints/entheses (21‐30), sacroiliac joint and lumbar spine radiograph, patient and physician global assessment (31‐35), morning stiffness (36‐39), ESR (40, 41), CRP (42,43), adverse effects (44‐46) and response rate. 1 … Comparison 1 SSZ vs placebo, Outcome 44 withdrawal for side effect. For patients refractory or intolerant to NSAIDs, the disease modifying antirheumatic drugs (DMARDs) have been used as a second line approach. 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