Sulfasalazine helps by decreasing bowel inflammation and abdominal (belly) pain. Methotrexate (MTX), a widely used disease-modifying antirheumatic drug (DMARD), is effective for rheumatoid arthritis (RA), and so might work for AS. - People who took placebo rated their pain to be 50 on a scale of 0 to 100 after 3 to 36 months. Arthritis Rheum. Perhaps because of its limited clinical effect on axial symptoms, its selective targeting to the smaller subset of patients with peripheral arthritis, or its sometimes‐troublesome side effects and requirements for laboratory monitoring, sulfasalazine has not been widely used in the treatment of AS. There was a statistically significant improvement, compared with baseline, in most of the clinical variables in patients receiving the active drug. During the physical exam, your doctor might ask you to bend in different directions to test the range of motion in your spine. The pooled MD for back pain measured on a 0 to 100 mm visual analogue scale was -2.96 (95% confidence interval (CI) -6.33 to 0.41; absolute risk difference 3%, 95% CI 1% to 6%; 6 trials). Eighty‐five patients with active ankylosing spondylitis (AS) were randomized to receive either sulfasalazine (≤3 gm/day, mean 2.5) or placebo for 26 weeks. The first … - People who took sulfasalazine rated their pain to be 3 points lower on a scale of 0 to 100 after 3 to 36 months than those who took placebo (3% absolute improvement). It occurs most frequently in white males 20 to 40 years old, although it can occur in children, too. DOI: 10.1002/14651858.CD004800.pub3, Copyright © 2020 The Cochrane Collaboration. We combined results using mean difference (MD) or standardised mean difference (SMD) for continuous data, and risk ratio (RR) for dichotomous data. Although the results of the ASCEND trial suggest a greater short‐term clinical benefit with etanercept, even in this group of patients who may be more sulfasalazine‐responsive, this trial does not address more clinically relevant questions that might elucidate whether sulfasalazine fills a niche in the strategies of AS treatment. Ankylosing spondylitis is the prototypical spondyloarthropathy and a systemic disorder characterized by inflammation of ... Sulfasalazine may help reduce peripheral joint symptoms and laboratory markers of inflammation in some patients. Bath ankylosing spondylitis function index (BASFI), Bath ankylosing spondylitis metrology index (BASMI), Total number of withdrawals due to adverse events. Acupuncture and herbs outperform sulfasalazine for the alleviation of ankylosing spondylitis. This outcome was not measured in the studies. Noting that some professional organizations recommend that a trial of sulfasalazine be considered for patients with active peripheral arthritis before a TNF inhibitor is prescribed, patients with peripheral arthritis were targeted for enrollment, but this was not an inclusion criterion. More withdrawals because of side effects occurred with sulfasalazine. It is important to note, however, that it may take several weeks for some NSAIDs to show positive results. Chen J, Lin S, Liu C. Sulfasalazine for ankylosing spondylitis. Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double-blind trial. Ankylosing spondylitis is a type of arthritis, usually in the joints and ligaments of the spine. Interventions for treating psoriatic arthritis, Anti-TNF-alpha drugs for treating ankylosing spondylitis, Self management programme for ankylosing spondylitis, Tumor necrosis factor (TNF) inhibitors for the treatment of psoriatic arthritis. Chen J, Liu C. J Rheumatol, 33(4):722-731, 01 Apr 2006 Cited by: 35 articles | PMID: 16583475. Review Corresponding Author. Bath ankylosing spondylitis disease activity index (BASDAI). If you do not receive an email within 10 minutes, your email address may not be registered, The main objective of initiating such therapy is to reduce pain, stiffness and discomfort. We restructured outcome measures for this update based on recommendations from the editorial group. Post Views: 219. Sulfasalazine for ankylosing spondylitis. We conducted a review of the effect of sulfasalazine for people with ankylosing spondylitis. A systematic review of randomized controlled trials. Sulfasalazine is a disease-modifying antirheumatic drug used in the treatment of AS. These questions separate the evaluation of sulfasalazine's effects on peripheral arthritis from its effects on overall AS in patients who also have peripheral manifestations, a distinction not always clearly made in the literature. We conducted a review of the effect of sulfasalazine for people with ankylosing spondylitis. - People who took sulfasalazine rated their pain to be 47 on a scale of 0 to 100 after 3 to 36 months. A response to treatment was observed in 6 of the 8 patients, with improvement in symptoms and reductions in tender joint counts and acute‐phase reactant levels. Sulfasalazine for ankylosing spondylitis is a topic covered in the Evidence-Based Medicine Guidelines.. To view the entire topic, please sign in or purchase a subscription.. Major outcomes included: pain, Bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis function index (BASFI), Bath ankylosing spondylitis metrology index (BASMI), radiographic progression, total number of withdrawals due to adverse events, and serious adverse events. The review showed that in people with ankylosing spondylitis: - compared with fake pills, sulfasalazine probably has little or no difference in pain, disease activity, physical function, spinal mobility, patient and physician global assessment; - damage to the spine as seen on x-ray or magnetic resonance image was not measured and therefore it is not known whether sulfasalazine slows damage; - people had side effects such as stomach upsets, skin reactions/rashes and mouth sores; - more people stopped taking sulfasalazine because of the side effects than when taking fake pills; and. In the original review, we included 11 studies in the analysis, involving 895 participants in total. 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. Sulfasalazine for the treatment of ankylosing spondylitis: Relic or niche medication? Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor α, Presence of peripheral arthritis and male sex predicting continuation of anti–tumor necrosis factor therapy in ankylosing spondylitis: an observational prospective cohort study from the South Swedish Arthritis Treatment Group Register, Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double‐blind trial, Ankylosing spondylitis and the spondyloarthropathies. Sulfasalazine for ankylosing spondylitis. Surveys in the US in the 1990s indicated that sulfasalazine was being administered to fewer than 20% of patients, even among those with moderately active or very active AS (5, 7). Other conventional disease‐modifying medications, such as methotrexate, have not been tested in large clinical trials, but the lack of adoption of these medications in clinical practice suggests that an important benefit in AS has not been overlooked (5). ASAS20 responses among subjects in the etanercept arm were higher than projected, and higher than those seen in placebo‐controlled trials of etanercept in AS, but comparable to those in other active comparator trials that studied etanercept. None of the included trials assessed BASDAI, BASFI, BASMI or radiographic progression. Eighteen percent of subjects had previously been treated with sulfasalazine. METHODS: We searched randomized and quasi-randomized trials in any language comparing SSZ with placebo in treatment of AS. Dosage: Sulfasalazine normally comes in 500mg tablets. Ankylosing spondylitis (AS) is a lifelong condition that has no cure. Use the link below to share a full-text version of this article with your friends and colleagues. - there is not enough evidence to be certain of the benefits and harms of sulfasalazine for ankylosing spondylitis, and more research is needed. Sulfasalazine was started at a dosage of 500 mg daily, which, appropriately, was escalated slowly so that the full dosage of 3 gm daily was not reached until week 6. Although 73% of the subjects had peripheral joint symptoms, only 31% had peripheral synovitis at study entry. As you've probably guessed by now, I have ankylosing spondylitis. To date, no intervention is available that alters the underlying mechanism of inflammation in AS. Sulfasalazine is an anti-inflammatory drug and is also used to treat rheumatoid arthritis and ulcerative colitis, a type of inflammatory bowel disease. Braun J(1), Pavelka K, Ramos-Remus C, Dimic A, Vlahos B, Freundlich B, Koenig AS. E-mail address: wardm1@mail.nih.gov. Eleven percent of etanercept‐treated subjects had injection‐site reactions that may have led to unblinding. The ASCEND trial was cast as an examination of treatment options for patients with AS whose peripheral joint involvement had persisted despite treatment with nonsteroidal antiinflammatory drugs, a group for whom there is some evidence to support the use of sulfasalazine. We judged most of the studies as low risk of bias or unclear risk of bias in five domains (random sequence generation, allocation concealment, blinding of outcome assessment, selective reporting, and other sources of bias). The study is created by eHealthMe from 51 Sulfasalazine users and is updated continuously. Other studies, however, indicated that the benefit of sulfasalazine was limited to improvements in the peripheral arthritis itself, whereas improvements in the axial symptoms were not observed in patients with peripheral arthritis (4). Although NSAIDs are commonly the first line of medications used to treat ankylosing spondylitis and related diseases, sometimes they aren’t enough to control the symptoms. However, its efficacy remains unclear. Management of ankylosing spondylitis (AS) is challenged by the progressive nature of the disease. Our findings are summarised below. Sulfasalazine (Azulfidine) has also been prescribed "off label" for Crohn's disease and ankylosing spondylitis. A serious adverse reaction was reported in one patient taking sulfasalazine (Peto odds ratio 7.50, 95% CI 0.15 to 378.16). However, even attending to these issues, it is not clear that equivalence would have been observed. A number of secondary end points, including decreases in the number of tender and swollen joints, physical function limitations, and serum C‐reactive protein levels, also favored etanercept. 2011 Jun;63(6):1543-51. doi: 10.1002/art.30223. Different parameters were used to assess pain. Clinical efficacy of etanercept versus sulfasalazine in ankylosing spondylitis subjects with peripheral joint involvement. Ankylosing Spondylitis: A Treatment Overview. In the Prospective Study of Outcomes in Ankylosing Spondylitis (PSOAS), a large observational study of patients enrolled at 5 rheumatology centers in the US, 30% of 888 patients reported ever having been treated with sulfasalazine (Ward M: unpublished observations). To evaluate the benefits and harms of sulfasalazine for the treatment of ankylosing spondylitis (AS). There is not enough evidence to support any benefit of sulfasalazine in reducing pain, disease activity, radiographic progression, or improving physical function and spinal mobility in the treatment of AS. Ankylosing spondylitis causes pain, stiffness, and swelling of the spine and sometimes other areas such as the hips, chest wall, and heels. Given that the study end points were assessed 10 weeks later, one can question whether the duration of treatment with sulfasalazine at full dose was sufficiently long to judge its potential effect. Pain and stiffness occur and limit movement in the back and in other joints that are affected. The full text of this article hosted at iucr.org is unavailable due to technical difficulties. Disagreements on the inclusion of the studies were resolved, when necessary, by recourse to a third review author. This is an update of a Cochrane review first published in 2005. We searched for relevant randomized and quasi-randomized trials in any language, using the following sources: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 11); MEDLINE (2003 to 28 November 2013); EMBASE (2003 to 27 November 2013); CINAHL (2003 to 28 November 2013); Ovid MEDLINE data, World Health Organization International Clinical Trials Registry Platform (28 November 2013); and the reference sections of retrieved articles. Sulfasalazine is a slow-acting anti-rheumatic drug (SAARD) that may be used to treat certain people with ankylosing spondylitis (AS). These findings are in contrast to those in studies showing the established efficacy and rapid adoption of TNF inhibitors to treat active AS. Braun J, van der Horst-Bruinsma IE, Huang F, Burgos-Vargas R, Vlahos B, Koenig AS, Freundlich B. Further studies, with larger sample sizes, longer duration, and using validated outcome measures are needed to verify the uncertainty of sulfasalazine in AS. - 23 more people taking sulfasalazine withdrew due to adverse events than those taking placebo. For example, in a trial of sulfasalazine in patients with AS, in whom the mean duration of AS was 5.4 years and 68% of whom had peripheral arthritis, sulfasalazine was significantly better than placebo in improving pain, patients' global assessments of disease, morning stiffness, chest expansion, and the erythrocyte sedimentation rate (3). A much larger question relates to how we are to apply these results in clinical practice. The former question examines peripheral arthritis as the outcome, while the latter question examines peripheral arthritis as a predictor of response. The primary outcome was the proportion of subjects in each group in whom an Assessment of SpondyloArthritis international Society 20% improvement (ASAS20) response was achieved, a measure that assesses spinal pain, morning stiffness, functioning, and patient's global assessment of disease, after 16 weeks of treatment. We use cookies to improve your experience on our site. John Reveille, John Davis, Jr., Michael Weisman, and Thomas Learch. After searching for all relevant studies up to November 2013, we found 11 studies involving 895 people. Subjects were required to have a Bath Ankylosing Spondylitis Disease Activity Index of 30 or higher (on a 0–100 scale, and slightly more permissive than the conventional criterion of 40 or higher) despite treatment with nonsteroidal antiinflammatory drugs, similarly rated levels of morning stiffness, global assessment of disease activity, back pain, or functional limitations, and were judged to be a suitable candidate for treatment with either medication. Sulfasalazine has shown to be effective for the peripheral joint involvement in ankylosing spondylitis and other SpA, but not for axial sypmtoms (14, 15). After searching for all relevant studies up to November 2013, we found 11 studies involving 895 people. However, not all subjects had peripheral joint involvement, and the primary end point assessed axial symptoms, not peripheral joint manifestations. - 13 out of 100 people taking sulfasalazine withdrew due to adverse events. Interestingly, the initial studies of TNF inhibitors in AS also enrolled a high proportion of patients with peripheral arthritis, and those with peripheral arthritis may respond better to treatment with TNF inhibitors than might patients with purely axial AS (9, 10). The administration of drugs constitutes an important component of the therapeutic programme in ankylosing spondylitis (AS). Michael M. Ward. However, the effect size was very small and not clinically meaningful. Cochrane Database of Systematic Reviews 2014, Issue 11. : CD004800. Spread the love. The primary goals of treatment of ankylosing spondylitis (AS) are to reduce axial musculoskeletal pain and stiffness, control enthesitis, improve fatigue, and preserve flexibility and mobility. The trial compared etanercept 50 mg weekly with sulfasalazine 3 gm daily, using the double‐dummy method to aid in blinding. The notable aspect of this study is that the trial enrolled patients with AS who were the most likely candidates to respond to sulfasalazine, thereby providing a more rigorous challenge to etanercept. Is sulfasalazine effective in ankylosing spondylitis? There was a statistically significant improvement, compared with baseline, in most of the clinical variables in patients receiving the active drug. the axial manifestations of ankylosing spondylitis. He or she might try to reproduce your pain by pressing on specific portions of your pelvis or by moving your legs into a particular position. The efficacy of sulfasalazine in dosages of 2–3 gm daily in improving the symptoms of AS was subsequently evaluated in several controlled trials. Sieper J, Klopsch T, Richter M, Kapelle A, Rudwaleit M, Schwank S, et al. Learn more. We conducted a review of the effect of sulfasalazine for people with ankylosing spondylitis. Many would consider 4–6 months of treatment with sulfasalazine at 3 gm daily to be an adequate trial (12). Second, among patients with both active axial manifestations and peripheral joint manifestations of AS, is a strategy of treatment with sulfasalazine first, followed by a TNF inhibitor for those who failed treatment with sulfasalazine, better than a strategy of treating with a TNF inhibitor from the start? Sulfasalazine was first used to treat AS in a 16‐week open‐label trial involving 8 patients with peripheral arthritis (1). Ankylosing Spondylitis (AS) is uncommon and rarely begins after the age of 45. It may also affect the shoulders, hips, or other joints. Author information: (1)Inflammation Disease Area, Specialty Care Business Unit, Pfizer Inc., 500 Arcola Road, Collegeville, PA 19422, USA. 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