Article: efficacy of sulfasalazine in ankylosing spondylitis
December 22, 2020 | Uncategorized
Results were combined using weighted mean difference or standardised mean difference for continuous data, and relative risk for dichotomous data. Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 1 Back pain (VAS‐100mm, 0 as no pain, 100 severe). doi: 10.1177/1759720X20975912. This result, however, could not be confirmed by subsequent larger randomized clinical trials (Dougados 1995, Clegg 1996, Clegg 1999). Comparison 1 SSZ vs placebo, Outcome 44 withdrawal for side effect. Can M, Aydın SZ, Niğdelioğlu A, Atagündüz P, Direskeneli H. Int J Rheum Dis. Sulfasalazine is a disease-modifying antirheumatic drug used in the treatment of AS. The outcomes in continuous data were presented as either end point values or change from baseline or both. These results showed that adverse effects of SSZ were obvious in some patients although the severe side effect was rare. This has to be examined further by separately analysing patients with peripheral arthritis. Peripheral joints/entheses were assessed in several studies (Clegg 1996, Dougados 1986, Kirwan 1993, Nissila 1988, Schmidt 2002). All eleven studies claimed randomized allocation. 4. 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. 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. 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. (3) SSZ might be beneficial in patients with peripheral arthritis. Across all AS patients, SSZ demonstrated some benefit in reducing ESR and easing morning stiffness, but there was no evidence of benefit in physical function, pain, spinal mobility, enthesitis, patient and physician global assessment. Ward MM, Kuzis S "Medication toxicity among patients with ankylosing spondylitis." - Across pivotal clinical trial programs, RINVOQ (15 mg, once daily) demonstrated efficacy across multiple measures of disease activity in psoriatic arthritis (PsA) and ankylosing spondylitis … Further studies on AS patients at early disease stage, with higher ESR (or active disease) and peripheral arthritis are needed to verify the efficacy of SSZ in these patients and the efficacy related factors. Zero to 68% of patients had complication of peripheral arthritis. 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). How safe is it? Both trials found that SSZ showed evidence of benefit in the occurrence of peripheral joint symptoms and peripheral responses in patients with peripheral arthritis. Two sensitivity analysis were performed according to whether: 1. the allocation to intervention or control groups was truly randomised or quasi‐randomised, to explore the potential for selection bias 2. the outcome assessment was blinded, to explore the potential for assessment bias associated with knowledge of the intervention If either of the sensitivity analyses affected the results of the review then conclusions would be made conservatively. Comparison 1 SSZ vs placebo, Outcome 37 Duration of morning stiffness (2nd analysis) (hr). the higher score the more severe disease). For patients without peripheral arthritis (N = 34), no significant difference was found in these outcomes (but articular index and degree of joint swelling were not assessed) except back pain VAS‐100 mm (where 0=no pain, 100=severe), which was showed to significantly favour SSZ over placebo (MD ‐9.20, 95% CI ‐17.81 to ‐0.59) (Comparison 03). doi: 10.1177/1759720X20951733. USA.gov. Comparison 1 SSZ vs placebo, Outcome 16 Occiput‐to‐wall test (cm). Comparison 1 SSZ vs placebo, Outcome 34 Improvement in physician global assessment. 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. 2020 Nov 28;12:1759720X20975912. Comparison 1 SSZ vs placebo, Outcome 18 Fingers‐to‐floor test (cm). In conducting meta‐analysis, we assumed that these medians were equal to means and calculated the SDs from CIs. Only one study (Winkler 1989) presented data of subgroups (patients with and without peripheral arthritis). To answer this question, scientists found and analyzed 11 research studies. But one study found that improvement did occur in people who had not had AS for very long, who had very active disease or peripheral arthritis (arthritis in arms and legs). 14 out of 100 people stopped taking sulfasalazine because of the side effects. Comparison 1 SSZ vs placebo, Outcome 22 Joint pain/tenderness score (2nd analysis) (0‐198, the higher score the more severe disease). 1 … 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. There was significant heterogeneity among the trials (p<0.0001) ((Comparison 01.12). Sulfasalazine. eCollection 2020. Epub 2012 Aug 31. The allocation concealment and blindness were rated as A or B. Sulfasalazine given orally for at least 12 weeks. Patients at early disease stage, with higher level of ESR (or active disease) and peripheral arthritis might benefit from SSZ. Comparison 1 SSZ vs placebo, Outcome 35 Respond to treatment (based on both patient and physician assessment). However, its efficacy … The strength of evidence in this review should be ranked as Gold level. Pooled data of withdrawal for ineffectiveness showed no significant difference between intervention groups (Comparison 01.45). Epub 2020 Apr 23. To evaluate the efficacy and toxicity of sulfasalazine for the treatment of ankylosing spondylitis. Peripheral response was defined as that at least 2 parameters got improved and none got worse. Conventional DMARD therapy (methotrexate-sulphasalazine) may decrease the requirement of biologics in routine practice of ankylosing spondylitis patients: a real-life experience. For allocation concealment, we scored as A (adequate), B (unclear), C (inadequate) and D (not used). eCollection 2020. Potential trials for inclusion were identified from the search results. Current guidelines suggest sulfasalazine (SSZ) treatment as initial therapy … Two studies (Clegg 1996, Winkler 1989) presented outcome data for subgroups (patients with peripheral arthritis and those without peripheral arthritis). Comparison 1 SSZ vs placebo, Outcome 41 ESR (2nd analysis) (mm/hr). 1. Comparison 1 SSZ vs placebo, Outcome 27 Enthesopathy index (0‐90, 0‐66, 0‐90? Twelve studies met the inclusion criteria but only eleven were included in the data analysis. Epub 2020 Sep 14. Difference of selection criteria is likely one reason why SSZ demonstrated benefit in some trials but not in others. Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 4 Schober's test (cm). These studies included almost 900 people with ankylosing spondylitis, most of them were male and 27 to 46 years old. 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). 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. Among the eleven included studies, some were well designed and well conducted. 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. WMD of change from baseline was 0.29 cm and 95% CI 0.15 to 0.44 cm. In addition, many trials used patient's subjective assessment as markers, eg duration of morning stiffness, pain severity which is liable to investigators' intention. 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. But when NSAIDs are not working well disease modifying anti‐rheumatic drugs (DMARDs), such as sulfasalazine may be used. Clipboard, Search History, and several other advanced features are temporarily unavailable. Comparison 1 SSZ vs placebo, Outcome 32 Patient assessment of disease severity (end point) (VAS‐100mm, 0=very good, 100= very poor,). Other outcomes remained similar. Sulfasalazine is frequently used for the treatment of both … 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. 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