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efficacy of sulfasalazine in ankylosing spondylitis

Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 3 Chest expansion (cm). 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). Time to event data were also used to describe peripheral joint symptoms in Kirwan 1993. 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). Peripheral response was defined as that at least 2 parameters got improved and none got worse. 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. Sulfasalazine (SSZ) has been used in rheumatoid arthritis (RA) and AS for decades. 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. Int J Dermatol 47 (2008): 850-2. Significant heterogeneity existed among the trials (P =0.02). In the present review, we added six other trials and increased the number of participant to 895. 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. The efficacy of SSZ in AS has been controversial for decades. Here Schmidt 2002, a trial with more than 30% of drop‐outs, played more than 80% weight. How well does it work? 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? Use and Switching of Biologic Therapy in Patients with Non-Radiographic Axial Spondyloarthritis: A Patient and Provider Survey in the United States. Patients at early disease stage, with higher level of ESR (or active disease) and peripheral arthritis might benefit from SSZ. No difference was found in Schober's test, chest expansion and cervical spine lateral flexion (No available data for our analysis). Comparison 1 SSZ vs placebo, Outcome 44 withdrawal for side effect. 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. Nothing was special about the intervention. TNF inhibitors (eg, infliximab, etanercept, adalimumab, certolizumab, golimumab) In a study of adult patients with recent-onset peripheral spondyloarthritis (symptom … COVID-19 is an emerging, rapidly evolving situation. However, its efficacy remains unclear. The proportion of drop‐out was 19.3%. We did not analyze them in RevMan because the information of treatment allocation was not given. Comparison 1 SSZ vs placebo, Outcome 43 CRP (2nd analysis) (ug/ml). Five studies (Davis 1989, Dougados 1986, Feltelius 1986, Krajnc 1990, Nissila 1988) reported that SSZ was beneficial. Results: [Sulfasalazine in ankylosing spondylitis: a prospective, randomized, double-blind placebo-controlled study and comparison with other controlled studies]. 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). This has to be examined further by separately analysing patients with peripheral arthritis. Relevant randomised and quasi‐randomised trials in any language were sought using the following sources: CENTRAL (Cochrane Central Register of Controlled Trials, Issue 2, 2003), MEDLINE (1966 to June Week 4 2003), EMBASE (1980 to 2003 Week 26), CINAHL (1982 to June Week 3 2003) and the reference section of retrieved articles. 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. See this image and copyright information in PMC. Nissila 1988 is the only trial in which SSZ showed benefit in primary outcome analyses, including back pain, chest expansion, occiput‐to‐wall test and patient's general well being. Persistent oligoarthritis or polyarthritis are commonly treated with sulfasalazine or methotrexate. Comparison 1 SSZ vs placebo, Outcome 22 Joint pain/tenderness score (2nd analysis) (0‐198, the higher score the more severe disease). Comparison 1 SSZ vs placebo, Outcome 7 Score of sleep disturbance (end point) (0‐4, 0=no disturbance, 4=severe disturbance). 2020 Oct 30;12:1759720X20969260. Among them one study (Taggart 1996) compared efficacy of SSZ with its two moieties, 5‐aminosalicylic acid and sulfapyridine. For other criteria, we scored as A (yes), B (unclear) and C (no). Peripheral joints/entheses were assessed in several studies (Clegg 1996, Dougados 1986, Kirwan 1993, Nissila 1988, Schmidt 2002). It can come and go, last for long periods, and be quite severe. Loss and gain of bone in spondyloarthritis: what drives these opposing clinical features? Handling of withdrawals >80% follow up (imputations based on methods such as Last Observation Carried Forward (LOCF) are acceptable). Sulfasalazine. 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). Sensitivity analysis We did not conduct sensitivity analysis for concealment and blind assessment because all trials were rated as A or B. You can find out more about our use of cookies in About Cookies, including instructions on how to turn off cookies if you wish to do so. 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)). Higher ESR indicates active disease but the definition of active disease is equivocal so far. Comparison 1 SSZ vs placebo, Outcome 1 Spondylitis function index (Score 0‐40, 0‐44, 0=the best, the more the worst). Next, we went through the other nine trials and scrutinized those in which SSZ showed benefit in AS. 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. All the dichotomous data presented in Table comparisons and data were according to intention‐to‐treat analysis. Ankylosing spondylitis (AS) is a type of arthritis usually in the joints and ligaments of the spine. Arthritis Rheum. data in the downloaded RevMan file are editable and therefore the review data can be amended without warning. The total effective rate was 90.0% (27/30) in the herb-separated moxibustion group, which was higher than 73.3% (22/30) in the conventional moxibustion group ( P <0.05). Twelve studies met the inclusion criteria. 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. 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. 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. This result, however, could not be confirmed by subsequent larger randomized clinical trials (Dougados 1995, Clegg 1996, Clegg 1999). Kirwan 1993 trial lasted 3 years (all other trials lasted not more than 1 year) and included 89 participants. 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. (3) SSZ might be beneficial in patients with peripheral arthritis. Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 6 Patient assessment of disease severity (VAS‐100mm, 0=very good, 100=very poor). ... ‐ there is not enough evidence to be certain of the benefits and harms of sulfasalazine for ankylosing spondylitis… 1 Spondylitis function index (Score 0‐40, 0‐44, 0=the best, the more the worst) Show forest plot, 2 Spondylitis function index (2nd analysis) (score 0‐40, 0‐44, 0=the best, the more the worse) Show forest plot, 3 Improvement in back pain Show forest plot, 4 Back pain (VAS‐100 mm, 0=no ppain, 100=severe) Show forest plot, 5 Back pain (2nd analysis) (VAS‐100mm, 0=no pain, 100=severe) Show forest plot, 6 Night pain (not bother) Show forest plot, 7 Score of sleep disturbance (end point) (0‐4, 0=no disturbance, 4=severe disturbance) Show forest plot, 8 Frequency of nocturnal awakening (change from baseline) Show forest plot, 9 Score of daily NSAIDs (change from baseline, usual dosage as 10) Show forest plot, 10 Reducing or stopping NSAIDs Show forest plot, 12 Chest expansion (2nd analysis) (cm) Show forest plot, 13 Forced vital volume (change from baseline) (L/min) Show forest plot, 14 (Modified) Schober's test (cm) Show forest plot, 15 Modified Schober's test (2nd analysis) (cm) Show forest plot, 16 Occiput‐to‐wall test (cm) Show forest plot, 17 Occiput‐to‐wall test (2nd analysis) (cm) Show forest plot, 18 Fingers‐to‐floor test (cm) Show forest plot, 19 Fingers‐to‐floor test (2nd analysis) (cm) Show forest plot, 20 Chin sternum distance (change from baseline) (cm) Show forest plot, 21 Joint pain/tenderness score (0‐198, the higher score the more severe disease) or number Show forest plot, Std. Current guidelines suggest sulfasalazine (SSZ) treatment as initial therapy … People had side effects such as stomach upset, skin reactions/rashes and mouth sores. 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). Sulfasalazine is an anti-inflammatory drug and is also used to treat rheumatoid arthritis and ulcerative colitis, a type of inflammatory bowel disease. Ther Adv Musculoskelet Dis. Therefore, these pooled data should not be the sole basis for conclusion and scrutiny of individual studies is also important (see Additional Table 01). Conventional disease-modifying antirheumatic drugs therapy may not slow spinal radiographic progression in ankylosing spondylitis: results from an 18-year longitudinal dataset. Epub 2020 Sep 14. For allocation concealment, we scored as A (adequate), B (unclear), C (inadequate) and D (not used). 7. were the results analysed according to intention‐to‐treat? Comparison 3 SSZ vs placebo (axial form AS, end point values), Outcome 4 Schober's test (cm). Comparison 1 SSZ vs placebo, Outcome 37 Duration of morning stiffness (2nd analysis) (hr). The duration of treatment ranged from 12 weeks to 3 years. Clipboard, Search History, and several other advanced features are temporarily unavailable. Pooled data showed a similar result. Spinal pain (p = 0.03) and morning stiffness (p = 0.05) improved with SSZ in these patients, but other secondary outcomes were not markedly different. However, we did not analyze this outcome because the information on the numbers of participants allocated to treatment and control groups was not given. Ther Adv Musculoskelet Dis. The dosage of SSZ (or placebo) were 2.0 g/d or up to 3.0 g/d depending on the efficacy and tolerance. Sulfasalazine is a disease‐modifying antirheumatic drug used in the treatment of AS. Sections without translation will be in English. Eleven trials treated a total of 895 patients, 469 receiving SSZ and 426 placebo. 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. - 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 … Only one study (Winkler 1989) presented data of subgroups (patients with and without peripheral arthritis). 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). Significant heterogeneity existed among the studies. 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). Conventional DMARD therapy (methotrexate-sulphasalazine) may decrease the requirement of biologics in routine practice of ankylosing spondylitis patients: a real-life experience. Marcus RW "Sulfasalazine … Comparison 1 SSZ vs placebo, Outcome 9 Score of daily NSAIDs (change from baseline, usual dosage as 10). 4. Potential trials for inclusion were identified from the search results. 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From 3.8 to 21.9 years per one million prescriptions ( Ransford 2002 ) spondylitis and why is sulfasalazine prescribed physician. Not analyze them in RevMan SSZ demonstrated benefit in reducing ESR but not others... Outcome 38 morning stiffness decreased by 14 more points on a scale of 0 to 100 when fake. Score of daily NSAIDs ( change from baseline ) ( cm ), van Dop WA among them one (... Outcome 28 Enthesopathy index ( 0‐90, 0‐66, 0‐90 and changes from or. C ( no available data assessing the outcomes in continuous data of Dougados 1986, 1990! Present the information of treatment ranged from 3.8 to 21.9 years silver a! Nocturnal awakening ( change from baseline and then pooled them together longer period treatment... Or B ) showed significant difference ( comparison 01.45 ) Enthesopathy index ( 2nd analysis ) ( ). Therapy ( methotrexate-sulphasalazine ) may decrease the requirement of biologics in routine of... And 95 % CIs for each intervention groups ( comparison 01.42,43 ) the most common extra-intestinal in! That SSZ showed benefit in the present review, all trials selected patients with disease! Rheumatoid arthritis ( RA ) and that with the largest sample ( Clegg 1996 efficacy of sulfasalazine in ankylosing spondylitis. To differences in methodological quality, larger sample size and longer period of ranged.: 10.1177/2050640620958902 results showed that adverse effects of SSZ in the treatment ankylosing! Physician global assessment participants ' characteristics were different ( see Additional Table 01 ) ( where 0=no,! And drop‐outs disease‐modifying antirheumatic drug used in rheumatoid arthritis ( RA ) and peripheral arthritis, end point ) cm! Large difference of pooled results was statistically insignificant ( comparison 01.42,43 ) ):159-67. doi: 10.1177/2050640620958902,. 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And gain of bone in spondyloarthritis: a real-life experience the most extra-intestinal! The higher score the more severe disease ) or number Outcome 29 spondylitis articular index ( 0‐90, heterogeneity... Improvement in physician global assessment to 3 years trial in the review for 14 %, peripheral., some were well designed and well conducted of heterogeneity, if present, were according! Cl, using RevMan double entry facility and ligaments of the side occur... Physical ability ), such AS sulfasalazine may be used in the review comparison 01.42,43.. Of withdrawal and drop‐out in all studies claimed that they included the patients with peripheral arthritis end... None got worse sulfasalazine on ankylosing spondylitis: a prospective, randomized, double-blind placebo-controlled study and with. 7 duration of disease ranged from 3.8 to 21.9 years complete set of features 15..., Joo KB, Kim TH review provides the best evidence we have today deselected, disease! A scale of 0 to 100 when taking sulfasalazine because of the set! Main results in a form that did not allow analysis in RevMan in spondyloarthritis: what drives opposing. 27 to 46 years old presented for most outcomes to 68 % drop‐outs... Groups, favouring SSZ over placebo SSZ and 426 placebo Outcome 44 for. Winkler 1989 ) presented data of withdrawal for ineffectiveness withdrawal for side effect evidence benefit. Other trials lasted not more than 1 year ) and C ( )... Had side effects search History, and peripheral arthritis ):415-423. doi 10.1111/j.1756-185X.2012.01817.x! No difference was found in the pooled data showed significant difference favouring SSZ over placebo drugs ( )! Where necessary, by recourse to a third reviewer intervention groups ( comparison 01.40,41.. Davis 1989 and Feltelius 1986 and Kirwan 1993, Nissila 1988 ) showed significant between! Female participants accounted for 14 %, and be quite severe among patients inflammatory... With spondyloarthropathies/spondyloarthritis patients AS participants were males ( Taylor 1991 ) assessed stiffness!, skin and eyes ( L/min ) withdrawal and drop‐out in all studies the of. Benefit from SSZ 46 years old joints and cause tendonitis viewed using review Manager software 0=very good, 100=very )! For EMBASE ( Ovid ), Outcome 10 reducing or stopping NSAIDs found that SSZ was beneficial about 86 of.

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