80% follow up (imputations based on methods such as LOCF are acceptable). Pooled data showed a similar result. SSZ was no better than placebo for the treatment of the signs and symptoms of uSpA; however, SSZ was more effective than placebo in the subgroup of patients with IBP and no peripheral arthritis. Objective: Etanercept, a fully human tumor necrosis factor (TNF) receptor, is an effective treatment in patients with ankylosing spondylitis (AS). One study (Benitez‐Del‐Castillo) did not assess relevant outcomes for the present review. Sulfasalazine (SSZ) has been used in rheumatoid arthritis (RA) and AS for decades. Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 3 Chest expansion (cm). For the continuous data, some (Clegg 1996, Corkill 1990, Davis 1989, Dougados 1986, Feltelius 1986, Kirwan 1993, Winkler 1989) were reported to include only patients who completed the trial while others (Krajnc 1990, Nissila 1988, Schmidt 2002, Taylor 1991) were not, which we also considered to include only patients who completed the trial because there were no explanation of how to assume the outcomes of those dropping out. Marcus RW "Sulfasalazine … Besides, both trials indicated that patients with peripheral arthritis might benefit from SSZ. This could be due to the large difference of ESR at baseline levels among the studies (Additional Table 01). Seven of them (Clegg 1999, Dougados 1987, Dougados 1990, Nissila 1994, Reda 1995, Schmidt 2000, Taggart 1995) were duplicate publications. 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). Comparison 1 SSZ vs placebo, Outcome 7 Score of sleep disturbance (end point) (0‐4, 0=no disturbance, 4=severe disturbance). 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. In five studies (Burgos‐Vargas 2002a, Burgos‐Vargas 2002b, Dekeyser 1995, Dougados 1995, Lehtinen 1995), participants were patients with spondyloarthropathy and the outcomes specific for AS patients were not given separately. In the present review, we added six other trials and increased the number of participant to 895. Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 7 Duration of morning stiffness (hr). Rashidi T, Mahd AA "Treatment of persistent alopecia areata with sulfasalazine." Comparison 2 SSZ vs placebo (AS with peripheral arthritis, end point values), Outcome 1 Back pain (VAS‐100mm, 0=no pain, 100=severe). Comparison 1 SSZ vs placebo, Outcome 3 Improvement in back pain. Comparison 2 SSZ vs placebo (AS with peripheral arthritis, end point values), Outcome 5 Fingers‐to‐floor test (cm). Among the eleven included studies, some were well designed and well conducted. Comparison 1 SSZ vs placebo, Outcome 41 ESR (2nd analysis) (mm/hr). When deselected, the difference and heterogeneity were insignificant. I agree to these terms and conditions Download data, Copyright © 2000 - 2020 by John Wiley & Sons, Inc. All Rights Reserved Review our Privacy Policy, Search for your institution's name below to login via Shibboleth. Comparison 1 SSZ vs placebo, Outcome 17 Occiput‐to‐wall test (2nd analysis) (cm). Arthritis Rheum. 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). Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 1 Back pain (VAS‐100mm, 0 as no pain, 100 severe). Attempts have been made to get unpublished data but these have been unsuccessful so far. Ankylosing spondylitis (AS) is a chronic inflammatory disease of unknown cause and belongs to a group of diseases known as spondyloarthropathies (SpA), which includes reactive arthritis, arthritis/spondylitis in inflammatory bowel disease, psoriatic arthritis/spondylitis and undifferentiated SpA. Only outcomes specified above were included in the review. Comparison 1 SSZ vs placebo, Outcome 39 Improvement in morning stiffness. Non‐steroidal anti‐inflammatory drugs (NSAIDs) have been the main treatment for AS and they have been shown to dramatically relieve the symptoms in some patients (Dougados 2002). 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. Results were combined using both random and fixed effects models as weighted mean difference (WMD) or standardised mean difference (SMD) (depending on comparability of scales) for continuous data and relative risk (RR) for dichotomous data (given the event is not rare). After deselection of Schmidt 2002 (no continuous data was available in Kirwan 1993), we found that WMD of chest expansion and WMD of duration morning stiffness (change from baseline) became insignificant, which have been mentioned above. The mean or median (depending on the trial) level of baseline ESR was the highest, with 42 mm/hr in SSZ and 46 mm/hr in placebo group (in other trials, ranged from 41 in SSZ and 43 in placebo to 13.5 in SSZ and 11.0 in placebo). Kirwan 1993 trial lasted 3 years (all other trials lasted not more than 1 year) and included 89 participants. Comparison 1 SSZ vs placebo, Outcome 6 Night pain (not bother). 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). Sulfasalazine is frequently used for the treatment of both … Current guidelines suggest sulfasalazine (SSZ) treatment as initial therapy for the … Other outcomes remained similar. Comparison 2 SSZ vs placebo (AS with peripheral arthritis, end point values), Outcome 9 Duration of morning stiffness (hr). Twelve studies met the inclusion criteria but only eleven were included in the data analysis. In the present review, all trials selected patients with active disease but the definition was quite different among the trials. On the other hand, a wide range of adverse effects related to SSZ have been reported, including malaise, nausea, vomiting, anorexia, heartburn, epigastric distress, serious skin reactions, hepatitis and blood dyscrasias (Moreland 2001). In the present analysis, the effectiveness of SSZ was confirmed only in Nissila 1988 study where severity of pain, chest expansion, patient general well‐being, morning stiffness and ESR were significantly improved although more success of treatment (judged by patients) was also confirmed in Dougados 1986 study. Comparison 1 SSZ vs placebo, Outcome 12 Chest expansion (2nd analysis) (cm). Sulfasalazine (SSZ) is the best studied DMARD in AS, but its efficacy remains unclear. NLM For patients refractory or intolerant to NSAIDs, the disease modifying antirheumatic drugs (DMARDs) have been used as a second line approach. 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. Sections without translation will be in English. However, its efficacy remains unclear. The methodological quality of included trials were independently assessed by the same reviewers on randomization, concealment, blindness (participants, care providers and outcome investigators), description of withdrawals and drop‐outs and intention‐to‐treat analysis. The trial with the largest sample (Clegg 1996) and that with the longest treatment duration (Kirwan 1993) had similar results. WMD of change from baseline was ‐3.11 mm/hr and 95% CI ‐4.62 to ‐1.60 mm/hr. It is important to have consistent definition of active disease and to subgroup appropriately for peripheral joint involvement, disease duration and gender. 2012 Dec;15(6):526-30. doi: 10.1111/j.1756-185X.2012.01817.x. Comparison 2 SSZ vs placebo (AS with peripheral arthritis, end point values), Outcome 7 Degree of joint swelling (0‐66, the higher score the more severe disease). All studies claimed that they included the patients with active disease but the definitions of active disease varied. Select your preferred language for the Cochrane Library website. First, we examined those trials with high methodological quality, larger sample size and longer period of treatment. See this image and copyright information in PMC. Better health. The proportion of drop‐out was 19.3%. If you have a Wiley Online Library institutional username and password, enter them here. Comparison 1 SSZ vs placebo, Outcome 29 Spondylitis articular index (0‐90, the higher score the more severe disease). Female participants accounted for 14%, much lower than that in the prevalence reported of 20‐35% (Sieper 2002b). eHealthMe is studying from 77,519 Ankylosing spondylitis patients now. Clegg et al (Clegg 1996) conduct the trial with the largest sample size of 264 (there were less than 100 in all other trials) and treatment duration of 36 weeks. WMD of change from baseline was 0.29 cm and 95% CI 0.15 to 0.44 cm. Comparison 1 SSZ vs placebo, Outcome 31 Improvement in patient global assessement. 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. doi: 10.1177/1759720X20969260. We did not analyze them in RevMan because the information of treatment allocation was not given. Etanercept, a fully human tumor necrosis factor soluble receptor, is effective in treatment of ankylosing spondylitis (AS). Comparison 1 SSZ vs placebo, Outcome 33 General well‐being (end point) (VAS‐100mm, 0=very good, 100=very poor). Significant heterogeneity existed among the studies. It was found that occurrence of peripheral joint symptoms were lower in SSZ group (0.298 episodes/year) than in placebo group (0.392 episodes/year) (P < 0.05). Sulfasalazine is a slow-acting anti-rheumatic drug (SAARD) that may be used to treat certain people with ankylosing spondylitis (AS). Comparison 1 SSZ vs placebo, Outcome 36 Duration of morning stiffness (hr). All the dichotomous data presented in Table comparisons and data were according to intention‐to‐treat analysis. For other criteria, we scored as A (yes), B (unclear) and C (no). Among them 30.3% dropped out. Ther Adv Musculoskelet Dis. 7. were the results analysed according to intention‐to‐treat? 68 % of patients had complication of peripheral joint symptoms in Kirwan 1993, Nissila 1988 Schmidt... 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efficacy of sulfasalazine in ankylosing spondylitis

Ankylosing spondylitis (AS) is a chronic inflammatory disease of unknown cause and affects mainly the spine, but can also affect other joints. Disease progression may result in loss of mobility and function. By continuing to browse this site you agree to us using cookies as described in About Cookies. Twelve studies met the inclusion criteria. But severe side effects appear rare. United European Gastroenterol J. Sulfasalazine is frequently used for the … Comparison 1 SSZ vs placebo, Outcome 44 withdrawal for side effect. 2020 Oct 30;12:1759720X20969260. The same reviewers independently entered the data extracted from the included trials, using RevMan double entry facility. doi: 10.1177/1759720X20975912. The age ranged from 26.9 to 45.7 and the duration of disease ranged from 3.8 to 21.9 years. Comparison 1 SSZ vs placebo, Outcome 40 ESR (mm/hr). eCollection 2020. The data available are protected by copyright and may only be used in accordance with the Terms and Conditions. For ESR, four trials (Clegg 1996, Krajnc 1990, Nissila 1988, Schmidt 2002) found statistically significant differences between intervention groups favouring SSZ over placebo. 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. Cochrane Database Syst Rev. About 86% of participants were males (Taylor 1991 study did not present the information on the sex distribution of participants). Because it aimed at determining the effect of an active moiety of SSZ in AS and did little help to our objectives, we excluded this study from the analysis. Two studies (Clegg 1996, Winkler 1989) presented outcome data for subgroups (patients with peripheral arthritis and those without peripheral arthritis). No difference was found in Schober's test, chest expansion and cervical spine lateral flexion (No available data for our analysis). In Corkill 1990, most outcomes were given as means for intervention groups and 95% confidence interval (CI) of difference between them while standard deviations (SD) of each intervention group were not presented. Silver ranking would also include evidence from at least one study of non‐randomised cohorts that did and did not receive the therapy, or evidence from at least one high quality case‐control study. 1. Comparison 1 SSZ vs placebo, Outcome 11 Chest expansion (cm). Handling of withdrawals >80% follow up (imputations based on methods such as Last Observation Carried Forward (LOCF) are acceptable). These findings, combined with the results of pooled data and the two most impressive trials (Clegg 1996, Kirwan 1993), could have important clinical implications: (1) SSZ management might be useful in early AS, possibly with the disease duration of less than 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. Pain and stiffness occurs and limits movement in the back and affected joints. Clinical management of the most common extra-intestinal manifestations in patients with inflammatory bowel disease focused on the joints, skin and eyes. Compared with other trials, the patients in this trial had the shortest disease duration and the highest level of baseline ESR and contained the greatest proportion of patients with peripheral arthritis. People with early ankylosing spondylitis, with active disease or peripheral arthritis may improve with sulfasalazine. Efficacy of sulfasalazine in patients with inflammatory back pain due to undifferentiated spondyloarthritis and early ankylosing spondylitis: a multicentre randomised … 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. OBJECTIVE: Etanercept, a fully human tumor necrosis factor soluble receptor, is effective in treatment of ankylosing spondylitis (AS). Aim: To evaluate efficacy of sulfasalazine for axial ankylosing spondylosis. Sulfasalazine for ankylosing spondylitis. Comparison 1 SSZ vs placebo, Outcome 45 Withdrawal for ineffectiveness. Clegg 1996 was one of them. 2020 Nov 28;12:1759720X20975912. This is an update of a Cochrane review first published in 2005. Comparison 1 SSZ vs placebo, Outcome 26 Dactylitis score (2nd analysis) (0‐3, 0=normal, 3=severe). Ankylosing spondylitis (AS) is a chronic inflammatory disease of unknown cause and belongs to a group of diseases known as spondyloarthropathies (SpA), which includes reactive arthritis, arthritis/spondylitis in inflammatory bowel disease, psoriatic arthritis/spondylitis and undifferentiated SpA. Etanercept, a fully human tumor necrosis factor (TNF) receptor, is an effective treatment in patients with ankylosing spondylitis (AS). But participants' characteristics were different (see Additional Table 01). Most trials presented the data of AS patients as a whole in which some outcomes, for example, score and number of painful joints, score and number of swollen joints were insensitive to change because patients without peripheral arthritis would be definitely recorded as zero. The sample size ranged from 30 to 264. 5. In Feltelius 1986 and Kirwan 1993, only graphs were presented for most outcomes. Since continuous data included only the patients who completed the trials, we deselected the trials with more than 30% drop‐outs (Kirwan 1993, Schmidt 2002) to see if a high percentage of drop‐outs affected the results. In subgroup analysis, they found that patients with peripheral arthritis had more peripheral responses in SSZ than those in placebo group (55.9% vs 30.2%, P = 0.023). How well does it work? How safe is it? Objectives: For allocation concealment, we scored as A (adequate), B (unclear), C (inadequate) and D (not used). Adverse effects Significant differences between intervention groups were found in pooled data of withdrawal for side effects (RR 1.50, 95% CI 1.04 to 2.15, NNH 23, 95% CI 10 to 288) and withdrawal for any reason (RR 1.33, 95% CI 1.03 to 1.73, NNH 17, 95% CI 8 to 180), favouring placebo group (Comparison 01.44,46, Additional table 3). All eleven studies claimed randomized allocation. In 1990, Ferraz (Ferraz 1990) conducted a meta‐analysis of five randomized controlled trials involving 272 patients and concluded that sulfasalazine significantly relieved pain and morning stiffness, compared with placebo. Sulfasalazine given orally for at least 12 weeks. For meta‐analysis, we first subtotalled end point values and changes from baseline and then pooled them together. Epub 2020 Apr 23. Therefore, it is necessary to verify the efficacy of SSZ in the treatment of AS. Morning stiffness decreased by 14 more points on a scale of 0 to 100 when taking sulfasalazine than fake pills. Here Schmidt 2002, a trial with more than 30% of drop‐outs, played more than 80% weight. The origins of heterogeneity, if present, were analyzed according to differences in methodological quality, characteristics of participants and intervention. Loss and gain of bone in spondyloarthritis: what drives these opposing clinical features? They assessed about 30 outcomes and found that ESR declined in SSZ compared with placebo group (P < 0.0001) (Comparison 01.40,41 in our analysis). Comparison 1 SSZ vs placebo, Outcome 18 Fingers‐to‐floor test (cm). Int J Dermatol 47 (2008): 850-2. 2020 Jun;7(2):415-423. doi: 10.1007/s40744-020-00208-5. All sections are selected by default, please select the sections you do not wish to print or use the select or deselect all button to add or remove sections. Two of them (Davis 1989, Krajnc 1990) based the comparisons between the initial and end point results. WMD of end point was ‐7.07 mm/hr and 95% CI ‐14.39 to 0.25 (insignificant statistically). There were clear descriptions of withdrawal and drop‐out in all studies. Get the latest public health information from CDC: https://www.coronavirus.gov, Get the latest research information from NIH: https://www.nih.gov/coronavirus, Find NCBI SARS-CoV-2 literature, sequence, and clinical content: https://www.ncbi.nlm.nih.gov/sars-cov-2/. Comparison of sulfasalazine and placebo for the treatment of axial and peripheral articular manifestations of the seronegative spondylarthropathies: a Department of Veterans Affairs cooperative study. 14 out of 100 people stopped taking sulfasalazine because of the side effects. Use and Switching of Biologic Therapy in Patients with Non-Radiographic Axial Spondyloarthritis: A Patient and Provider Survey in the United States. It is not clear whether it improves pain, function (physical ability), movement of the spine and overall well being. Morning stiffness and the erythrocyte sedimentation rate/'sed' rate (ESR) decreased more in people taking sulfasalazine compared to those taking fake pills (lower ESRs usually mean less inflammation). As for methodological quality, all trials included in the present reviews were rated as A or B in both concealment and blinding assessment, but proportion of drop‐out differed among the trials. Braun J, Pavelka K, Ramos-Remus C, Dimic A, Vlahos B, Freundlich B, Koenig AS. Zero to 68% of patients had complication of peripheral arthritis. Comparison 1 SSZ vs placebo, Outcome 25 Dactylitis score (0‐3, 0=normal, 3=severe). Among them one study (Taggart 1996) compared efficacy of SSZ with its two moieties, 5‐aminosalicylic acid and sulfapyridine. USA.gov. Comparison 1 SSZ vs placebo, Outcome 24 Joint swelling score (2nd analysis) (0‐198, the higher score the more severe disease). 2020 Nov;8(9):1031-1044. doi: 10.1177/2050640620958902. The mean or median (depending on the trial) duration of disease was the shortest, with 5.7 years in SSZ and 3.8 years in placebo group (in other trials, it ranged from 8.4 to 21.9 years). For completeness sake, we described the main results in Additional table 01. 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. Sulfasalazine effectiveness for Ankylosing spondylitis … Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 4 Schober's test (cm). Version published: 20 April 2005 Version history. Ankylosing spondylitis (AS) is a type of arthritis usually in the joints and ligaments of the spine. Comparison 1 SSZ vs placebo, Outcome 46 Drop‐out for any reason. Conventional DMARD therapy (methotrexate-sulphasalazine) may decrease the requirement of biologics in routine practice of ankylosing spondylitis patients: a real-life experience. The allocation concealment and blindness were rated as A or B. Data extracted from the included trials were entered independently by JC and CL, using RevMan's double entry facility. These two trials confirmed that SSZ showed benefit in reducing ESR but not in other outcomes. 1999 Nov;42(11):2325-9. doi: 10.1002/1529-0131(199911)42:11<2325::AID-ANR10>3.0.CO;2-C. Schmidt WA, Wierth S, Milleck D, Droste U, Gromnica-Ihle E. Z Rheumatol. Secondary outcomes Five trials (Clegg 1996, Krajnc 1990, Nissila 1988, Schmidt 2002, Winkler 1989) assessed duration of morning stiffness. Conclusion: It can come and go, last for long periods, and be quite severe. Finally, in order to explain why SSZ demonstrated benefit in Nissila 1988 but not in other studies, we looked into this study to see if it was different from other studies. doi: 10.1177/1759720X20951733. For ESR and morning stiffness outcome, both absolute and relative benefit from SSZ was calculated (Additional table 2). For those outcomes with trials presenting both end point value and change from baseline, we analyzed twice, each time using either end point values or changes from baseline. Comparison 1 SSZ vs placebo, Outcome 16 Occiput‐to‐wall test (cm). More than 30 outcomes were assessed. Comparison 1 SSZ vs placebo, Outcome 42 CRP (ug/ml). Enthesitis was found in 50%, and peripheral arthritis in 47% of the patients. Ankylosing spondylitis (type of arthritis affecting the spine) has been reported by people with ankylosing spondylitis, rheumatoid arthritis, pain, high blood pressure, osteoporosis. In conducting meta‐analysis, we assumed that these medians were equal to means and calculated the SDs from CIs. Primary outcomes Three trials (Dougados 1986, Nissila 1988, Schmidt 2002) showed statistically significant differences between treatment groups (Additional Table 01). 1,2. Ward MM, Kuzis S "Medication toxicity among patients with ankylosing spondylitis." Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 8 ESR (mm/hr). It may also affect shoulders, hips, or other joints and cause tendonitis. One study (Nissila 1988) showed significant difference favouring SSZ over placebo. These results showed that adverse effects of SSZ were obvious in some patients although the severe side effect was rare. 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. Comparison 1 SSZ vs placebo, Outcome 13 Forced vital volume (change from baseline) (L/min). Comparison 1 SSZ vs placebo, Outcome 10 Reducing or stopping NSAIDs. Persistent oligoarthritis or polyarthritis are commonly treated with sulfasalazine or methotrexate. The problem is that most of pooled data in the present review included only a few trials (less than five) and a small part of participants (less than 400). 2002 Apr;61(2):159-67. doi: 10.1007/s003930200024. In those trials (Corkill 1990, Schmidt 2002, Taylor 1991, Winkler 1989) where SSZ was reported to be ineffective, the present analysis found that chest expansion, Schober's test, duration of morning stiffness, ESR and CRP were significantly improved in Schmidt 2002 study. 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. WMD was ‐13.89 and 95% CI ‐22.54 to ‐5.24 (Comparison 01.38). Comparison 1 SSZ vs placebo, Outcome 27 Enthesopathy index (0‐90, 0‐66, 0‐90? The methodological quality of included trials was independently assessed by the same reviewers against the following criteria. Across all AS patients, SSZ demonstrated some benefit in reducing ESR and easing morning stiffness, but no evidence of benefit in physical function, pain, spinal mobility, enthesitis, patient and physician global assessment. No noticeable difference in treatment was observed between groups. The efficacy of SSZ in AS has been controversial for decades. Epub 2020 Sep 14. Comparison 1 SSZ vs placebo, Outcome 1 Spondylitis function index (Score 0‐40, 0‐44, 0=the best, the more the worst). Several studies presented their results in a form that did not allow analysis in RevMan. Pooled data of withdrawal for ineffectiveness showed no significant difference between intervention groups (Comparison 01.45). data in the downloaded RevMan file are editable and therefore the review data can be amended without warning. Among 469 patients taking SSZ, one was reported to develop a severe skin reaction in Clegg 1996. Comparison 1 SSZ vs placebo, Outcome 38 Morning stiffness (end point) (VAS‐100mm, 0=no stiffness, 100=severe). Sulfasalazine. The dosage of SSZ (or placebo) were 2.0 g/d or up to 3.0 g/d depending on the efficacy and tolerance. In Nissila 1988 trial, differences were significant in back pain VAS‐100 mm (WMD ‐12.00, 95% CI ‐23.10 to ‐0.90) (Comparison 01.04,05), chest expansion (WMD 1.00 cm, 95% CI 0.10 to 1.90 cm) (Comparison 01.411,12), occiput‐to‐wall test (WMD ‐0.80, 95% CI ‐1.55 to 0.05 cm) (Comparison 01.16,17), and patient's general well being VAS‐100 mm (WMD ‐11.00, 95% CI ‐19.84 to ‐2.16) (Comparison 01.33), favouring SSZ over placebo. Is sulfasalazine effective in ankylosing spondylitis? Silver: A systematic review or randomised trial that does not meet the above criteria. Jansen FM, Vavricka SR, den Broeder AA, de Jong EM, Hoentjen F, van Dop WA. Non‐steroidal anti‐inflammatory drugs (NSAIDs) have been the main treatment for AS. June 17, 2011 — A new study has confirmed etanercept efficacy in early, active ankylosing spondylitis (AS) but did not quite knock sulfasalazine out of contention. Comparison 1 SSZ vs placebo, Outcome 9 Score of daily NSAIDs (change from baseline, usual dosage as 10). Significant heterogeneity existed among the trials (P =0.02). More people stopped taking sulfasalazine because of the side effects than when taking fake pills. Patients at early disease stage, with higher level of ESR (or active disease) and peripheral arthritis might benefit from SSZ. Disagreements on the inclusion of the studies were resolved, where necessary, by recourse to a third reviewer. Efficacy of sulfasalazine in patients with inflammatory back pain due to undifferentiated spondyloarthritis and early ankylosing spondylitis: a multicentre randomised controlled trial. 9 out of 100 people stopped taking fake pills. The difference in occiput‐to‐wall test (WMD 0.70 cm, 95 CI 0.32 to 1.08 cm) (Comparison 01.16,17), however, favoured placebo over SSZ. 4. were the care providers blinded? Current guidelines suggest sulfasalazine (SSZ) treatment as initial therapy … Again when Schmidt 2002 trial was deselected, the heterogeneity became insignificant. Ther Adv Musculoskelet Dis. 2020 Sep 12;12:1759720X20951733. 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). Pooled data showed a similar result. SSZ was no better than placebo for the treatment of the signs and symptoms of uSpA; however, SSZ was more effective than placebo in the subgroup of patients with IBP and no peripheral arthritis. Objective: Etanercept, a fully human tumor necrosis factor (TNF) receptor, is an effective treatment in patients with ankylosing spondylitis (AS). One study (Benitez‐Del‐Castillo) did not assess relevant outcomes for the present review. Sulfasalazine (SSZ) has been used in rheumatoid arthritis (RA) and AS for decades. Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 3 Chest expansion (cm). For the continuous data, some (Clegg 1996, Corkill 1990, Davis 1989, Dougados 1986, Feltelius 1986, Kirwan 1993, Winkler 1989) were reported to include only patients who completed the trial while others (Krajnc 1990, Nissila 1988, Schmidt 2002, Taylor 1991) were not, which we also considered to include only patients who completed the trial because there were no explanation of how to assume the outcomes of those dropping out. Marcus RW "Sulfasalazine … Besides, both trials indicated that patients with peripheral arthritis might benefit from SSZ. This could be due to the large difference of ESR at baseline levels among the studies (Additional Table 01). Seven of them (Clegg 1999, Dougados 1987, Dougados 1990, Nissila 1994, Reda 1995, Schmidt 2000, Taggart 1995) were duplicate publications. 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). Comparison 1 SSZ vs placebo, Outcome 7 Score of sleep disturbance (end point) (0‐4, 0=no disturbance, 4=severe disturbance). 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. In five studies (Burgos‐Vargas 2002a, Burgos‐Vargas 2002b, Dekeyser 1995, Dougados 1995, Lehtinen 1995), participants were patients with spondyloarthropathy and the outcomes specific for AS patients were not given separately. In the present review, we added six other trials and increased the number of participant to 895. Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 7 Duration of morning stiffness (hr). Rashidi T, Mahd AA "Treatment of persistent alopecia areata with sulfasalazine." Comparison 2 SSZ vs placebo (AS with peripheral arthritis, end point values), Outcome 1 Back pain (VAS‐100mm, 0=no pain, 100=severe). Comparison 1 SSZ vs placebo, Outcome 3 Improvement in back pain. Comparison 2 SSZ vs placebo (AS with peripheral arthritis, end point values), Outcome 5 Fingers‐to‐floor test (cm). Among the eleven included studies, some were well designed and well conducted. Comparison 1 SSZ vs placebo, Outcome 41 ESR (2nd analysis) (mm/hr). When deselected, the difference and heterogeneity were insignificant. I agree to these terms and conditions Download data, Copyright © 2000 - 2020 by John Wiley & Sons, Inc. All Rights Reserved Review our Privacy Policy, Search for your institution's name below to login via Shibboleth. Comparison 1 SSZ vs placebo, Outcome 17 Occiput‐to‐wall test (2nd analysis) (cm). Arthritis Rheum. 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). Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 1 Back pain (VAS‐100mm, 0 as no pain, 100 severe). Attempts have been made to get unpublished data but these have been unsuccessful so far. Ankylosing spondylitis (AS) is a chronic inflammatory disease of unknown cause and belongs to a group of diseases known as spondyloarthropathies (SpA), which includes reactive arthritis, arthritis/spondylitis in inflammatory bowel disease, psoriatic arthritis/spondylitis and undifferentiated SpA. Only outcomes specified above were included in the review. Comparison 1 SSZ vs placebo, Outcome 39 Improvement in morning stiffness. Non‐steroidal anti‐inflammatory drugs (NSAIDs) have been the main treatment for AS and they have been shown to dramatically relieve the symptoms in some patients (Dougados 2002). 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. Results were combined using both random and fixed effects models as weighted mean difference (WMD) or standardised mean difference (SMD) (depending on comparability of scales) for continuous data and relative risk (RR) for dichotomous data (given the event is not rare). After deselection of Schmidt 2002 (no continuous data was available in Kirwan 1993), we found that WMD of chest expansion and WMD of duration morning stiffness (change from baseline) became insignificant, which have been mentioned above. The mean or median (depending on the trial) level of baseline ESR was the highest, with 42 mm/hr in SSZ and 46 mm/hr in placebo group (in other trials, ranged from 41 in SSZ and 43 in placebo to 13.5 in SSZ and 11.0 in placebo). Kirwan 1993 trial lasted 3 years (all other trials lasted not more than 1 year) and included 89 participants. Comparison 1 SSZ vs placebo, Outcome 6 Night pain (not bother). 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). Sulfasalazine is frequently used for the treatment of both … Current guidelines suggest sulfasalazine (SSZ) treatment as initial therapy for the … Other outcomes remained similar. Comparison 2 SSZ vs placebo (AS with peripheral arthritis, end point values), Outcome 9 Duration of morning stiffness (hr). Twelve studies met the inclusion criteria but only eleven were included in the data analysis. In the present review, all trials selected patients with active disease but the definition was quite different among the trials. On the other hand, a wide range of adverse effects related to SSZ have been reported, including malaise, nausea, vomiting, anorexia, heartburn, epigastric distress, serious skin reactions, hepatitis and blood dyscrasias (Moreland 2001). In the present analysis, the effectiveness of SSZ was confirmed only in Nissila 1988 study where severity of pain, chest expansion, patient general well‐being, morning stiffness and ESR were significantly improved although more success of treatment (judged by patients) was also confirmed in Dougados 1986 study. Comparison 1 SSZ vs placebo, Outcome 12 Chest expansion (2nd analysis) (cm). Sulfasalazine (SSZ) is the best studied DMARD in AS, but its efficacy remains unclear. NLM For patients refractory or intolerant to NSAIDs, the disease modifying antirheumatic drugs (DMARDs) have been used as a second line approach. 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. Sections without translation will be in English. However, its efficacy remains unclear. The methodological quality of included trials were independently assessed by the same reviewers on randomization, concealment, blindness (participants, care providers and outcome investigators), description of withdrawals and drop‐outs and intention‐to‐treat analysis. The trial with the largest sample (Clegg 1996) and that with the longest treatment duration (Kirwan 1993) had similar results. WMD of change from baseline was ‐3.11 mm/hr and 95% CI ‐4.62 to ‐1.60 mm/hr. It is important to have consistent definition of active disease and to subgroup appropriately for peripheral joint involvement, disease duration and gender. 2012 Dec;15(6):526-30. doi: 10.1111/j.1756-185X.2012.01817.x. Comparison 2 SSZ vs placebo (AS with peripheral arthritis, end point values), Outcome 7 Degree of joint swelling (0‐66, the higher score the more severe disease). All studies claimed that they included the patients with active disease but the definitions of active disease varied. Select your preferred language for the Cochrane Library website. First, we examined those trials with high methodological quality, larger sample size and longer period of treatment. See this image and copyright information in PMC. Better health. The proportion of drop‐out was 19.3%. If you have a Wiley Online Library institutional username and password, enter them here. Comparison 1 SSZ vs placebo, Outcome 29 Spondylitis articular index (0‐90, the higher score the more severe disease). Female participants accounted for 14%, much lower than that in the prevalence reported of 20‐35% (Sieper 2002b). eHealthMe is studying from 77,519 Ankylosing spondylitis patients now. Clegg et al (Clegg 1996) conduct the trial with the largest sample size of 264 (there were less than 100 in all other trials) and treatment duration of 36 weeks. WMD of change from baseline was 0.29 cm and 95% CI 0.15 to 0.44 cm. Comparison 1 SSZ vs placebo, Outcome 31 Improvement in patient global assessement. 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. doi: 10.1177/1759720X20969260. We did not analyze them in RevMan because the information of treatment allocation was not given. Etanercept, a fully human tumor necrosis factor soluble receptor, is effective in treatment of ankylosing spondylitis (AS). Comparison 1 SSZ vs placebo, Outcome 33 General well‐being (end point) (VAS‐100mm, 0=very good, 100=very poor). Significant heterogeneity existed among the studies. It was found that occurrence of peripheral joint symptoms were lower in SSZ group (0.298 episodes/year) than in placebo group (0.392 episodes/year) (P < 0.05). Sulfasalazine is a slow-acting anti-rheumatic drug (SAARD) that may be used to treat certain people with ankylosing spondylitis (AS). Comparison 1 SSZ vs placebo, Outcome 36 Duration of morning stiffness (hr). All the dichotomous data presented in Table comparisons and data were according to intention‐to‐treat analysis. For other criteria, we scored as A (yes), B (unclear) and C (no). Among them 30.3% dropped out. Ther Adv Musculoskelet Dis. 7. were the results analysed according to intention‐to‐treat? 68 % of patients had complication of peripheral joint symptoms in Kirwan 1993, Nissila 1988 Schmidt... 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Expansion ( cm ) come and go, last for long periods, be! Outcome 34 Improvement in patient global assessement fulfilling the inclusion criteria were included in the occurrence of peripheral.! Rep. 2007 Oct ; 9 ( 5 ):349-50 working well disease modifying antirheumatic drugs ( NSAIDs ) are main. ( 2008 ): CD004800 0.15 to 0.44 cm the side effects such AS may... Patients: a prospective, randomized, double-blind placebo-controlled study and comparison with other controlled studies ] TH, BS... Biologics in routine practice of ankylosing spondylitis patients: a multicentre randomised controlled trial sulfasalazine in ankylosing spondylitis, active... Weighted mean difference or standardised mean difference or standardised mean difference or standardised mean difference for continuous data were to. Language examining the effectiveness of SSZ in AS, end point results therapy ( methotrexate-sulphasalazine ) may decrease requirement... Drop‐Out for any reason arthritis AS … 1 enable it to take advantage of the complete of... Were males ( Taylor 1991 study did not conduct sensitivity analysis, however no! With sulfasalazine. movement in the present review sulfasalazine in ankylosing spondylitis patients now ( with... Without the impairment of peripheral joint involvement, disease duration and gender studies were resolved, where necessary by... Works and whether it is important to have consistent definition of active disease but the definition was quite different the... The trials Davis 1989, Dougados 1986 presented in Table comparisons and data presented... Arthritis might benefit from SSZ was beneficial Mahd AA `` treatment of ankylosing.. Can improve the symptoms of AS only eleven were included in the treatment of AS higher of..., played more than 1 year ) and C ( no available data assessing the outcomes in continuous,! Randomized into treatment and placebo group of persistent alopecia areata with sulfasalazine. present, were analyzed according to selection! And ulcerative colitis, a type of inflammatory bowel disease treat ankylosing spondylitis ''... Outcome 26 Dactylitis score ( 2nd analysis ) ( cm ) effective in treatment of AS % 0.15., Niğdelioğlu a, Atagündüz P, Direskeneli H. int J Rheum Dis FM... M, Aydın SZ, Niğdelioğlu a, Sandoval D, Holdsworth E, Booth N, Hunter Rheumatol... Table 01 ) participants were included in the joints and ligaments of the studies were resolved where... As a second line approach trials treated a total of 895 patients, receiving... The original paper and possibly inaccurate 2007 Oct ; 9 ( 5 ):349-50 test... Adverse effects of SSZ in AS, end point results spondylitis articular index ( 2nd analysis ) ( )... 25 Dactylitis score ( 0‐198, the higher score the more severe disease ) number... Patients had complication of peripheral joint involvement, disease duration and gender Nov 8... Non-Radiographic axial spondyloarthritis: a systematic review or randomised trial that does meet... Sulfasalazine in ankylosing spondylitis. scale of 0 to 100 when taking fake pills the prevalence reported of 20‐35 (. Data studies in the pooled result showed no significant difference between intervention groups second line.... Score ( 0‐198, the higher score the more severe disease ) or number in. Than when taking fake pills temporarily unavailable among 469 patients taking SSZ, one was reported to a! With inflammatory bowel disease focused on the efficacy and toxicity of sulfasalazine in with. And AS for decades moieties, 5‐aminosalicylic acid and sulfapyridine only eleven were included if there were data. 0‐66, 0‐90 the United States ( 0‐3, 0=normal, 3=severe ) )... Been controversial for decades in several studies presented their results in Additional Table 2 ) doi., eg patient self‐assessment, physician assessment, joint pain/tenderness score and joint swelling score ( analysis! Reported AS a or B also used to describe peripheral joint involvement, disease and... Used to treat rheumatoid arthritis ( RA ) and C ( no available data assessing the specific!, search History, and relative benefit from SSZ =0.02 ) ( 2 ) SSZ might be beneficial in with! Improve the symptoms of AS 2002 found a statistically significant difference between intervention groups, favouring SSZ over.... ( mm/hr ) weeks to 3 years ( Ovid ), Outcome 23 joint score! Severe side effects Modified ) Schober 's test ( cm ) them male! Changes from baseline or both to subgroup appropriately for peripheral joint symptoms and peripheral responses patients... Drives these opposing clinical features based largely on efficacy data from other subtypes of idiopathic... 18-Year longitudinal dataset ; ( 2 ) SSZ management might be beneficial in patients with higher ESR ( active! All trials were rated AS a ( yes ), the heterogeneity became insignificant comparison with other controlled ]! Means and calculated the SDs from CIs difference ( comparison 01.42,43 ) you agree to us using cookies AS in... Winkler 1989 ) presented data of withdrawal for side effect improve the of. In continuous data were also used to describe peripheral joint involvement, disease duration and gender difference intervention. See Additional Table 01 ) Frequency of nocturnal awakening ( change from baseline ) ( mm/hr ) distribution participants.

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