Further studies, with larger sample sizes, longer duration, and using validated outcome measures are needed to verify the uncertainty of sulfasalazine in AS. 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.. Braun J(1), Pavelka K, Ramos-Remus C, Dimic A, Vlahos B, Freundlich B, Koenig AS. Is sulfasalazine effective in ankylosing spondylitis? Disagreements on the inclusion of the studies were resolved, when necessary, by recourse to a third review author. What is ankylosing spondylitis and what is sulfasalazine? It may also affect the shoulders, hips, or other joints. 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. Sulfasalazine for the treatment of ankylosing spondylitis: Relic or niche medication? Corresponding Author. Pain and stiffness occur and limit movement in the back and in other joints that are affected. JC: Registered the title; developed the protocol; searched for relevant studies; selected the studies and assessed their risk of bias; extracted and synthesized the data; and wrot Sulfasalazine for ankylosing spondylitis. 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. Before the introduction of tumor necrosis factor (TNF) inhibitors, sulfasalazine was the slow‐acting medication most often used to treat patients with AS whose symptoms were not adequately controlled with nonsteroidal antiinflammatory medications, exercise, and rehabilitative therapies. There was a statistically significant improvement, compared with baseline, in most of the clinical variables in patients receiving the active drug. 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. 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. 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. After searching for all relevant studies up to November 2013, we found 11 studies involving 895 people. We conducted a review of the effect of sulfasalazine for people with ankylosing spondylitis. 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. Working off-campus? John Reveille, John Davis, Jr., Michael Weisman, and Thomas Learch. Ankylosing Spondylitis is a very painful and debilitating arthritis of the spine. Although 73% of the subjects had peripheral joint symptoms, only 31% had peripheral synovitis at study entry. - 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). Side effects, warnings and precautions, drug interactions, and safety during pregnancy should be reviewed prior to taking this medication. Methods: Two hundred sixty-four patients with AS were recruited from 15 clinics, randomized (double-blind) to SSZ or placebo treatment, and followed up for 36 weeks. To date, no intervention is available that alters the underlying mechanism of inflammation in AS. Chen J, Lin S, Liu C. Sulfasalazine for ankylosing spondylitis. 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. Two review authors independently reviewed unblinded trial reports according to the selection criteria. This large, well‐executed trial suggests that etanercept is more efficacious than sulfasalazine in the treatment of AS symptoms overall. Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double-blind trial. The short trial duration may therefore have affected the comparison of efficacy. Sieper J, Klopsch T, Richter M, Kapelle A, Rudwaleit M, Schwank S, et al. Ankylosing Spondylitis (AS) is uncommon and rarely begins after the age of 45. [J Chen, C Liu] PMID 15846731 . 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. - there is not enough evidence to be certain of the benefits and harms of sulfasalazine for ankylosing spondylitis, and more research is needed. Art. 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. Data were extracted from the chosen studies and … First, among patients with AS who have active peripheral joint manifestations but mild axial symptoms (that would not warrant treatment with TNF inhibitors), is sulfasalazine or a TNF inhibitor a better treatment? Treatment with Sulfasalazine in ankylosing spondylitis may take from three to nine months, ... A qualified physician can determine the dosages to find the balance between harm and benefit from the use of medications. 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. We evaluated randomized and quasi-randomized trials examining the benefits and harms of sulfasalazine on AS. Seventy‐six percent of subjects treated with etanercept had an ASAS20 response at 16 weeks, compared to 53% of those treated with sulfasalazine. None of the included trials assessed BASDAI, BASFI, BASMI or radiographic progression. Few patients had to be withdrawn from the trial, and both medications were well tolerated. 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). Michael M. Ward. This is an update of a Cochrane review first published in 2005. We conducted a review of the effect of sulfasalazine for people with 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. Sulfasalazine is a slow-acting anti-rheumatic drug (SAARD) that may be used to treat certain people with ankylosing spondylitis (AS). Sulfasalazine has shown to be effective for the peripheral joint involvement in ankylosing spondylitis and other SpA, but not for axial sypmtoms (14, 15). Given the chronic nature of AS, outcomes in such a study would need to include not only symptom control, but also toxicities and costs, likely examined over several years. 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). These questions about the role of sulfasalazine in the treatment of patients with AS remain open. Enter your email address below and we will send you your username, If the address matches an existing account you will receive an email with instructions to retrieve your username, I have read and accept the Wiley Online Library Terms and Conditions of Use, Sulfasalazine in the treatment of ankylosing spondylitis: a twenty‐six–week, placebo‐controlled clinical trial, Comparison of sulfasalazine and placebo for the treatment of axial and peripheral manifestations of the seronegative spondyloarthropathies: a Department of Veterans Affairs cooperative study, Treatments used by patients with ankylosing spondylitis: comparison with the treatment preferences of rheumatologists, Sulfasalazine in the prevention of anterior uveitis associated with ankylosing spondylitis, Medication toxicity among patients with ankylosing spondylitis. 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. Eleven percent of etanercept‐treated subjects had injection‐site reactions that may have led to unblinding. Our findings are summarised below. Although prior ineffectiveness of sulfasalazine was an exclusion criterion, the comparisons would have been cleaner if subjects had been required to be treatment naive, having never received either active treatment at study start. The purpose of this randomized trial was to compare the short‐term efficacy of sulfasalazine and etanercept in improving overall disease activity in patients with active AS. No. 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). Average maintenance dose is 2g (4 tablets) daily, although higher doses are not uncommon. We conducted a review of the effect of sulfasalazine for people with ankylosing spondylitis. Most subjects had relatively early and active AS. Objective: To determine whether sulfasalazine (SSZ) at a dosage of 2,000 mg/day is effective for the treatment of active ankylosing spondylitis (AS) that is not controlled with nonsteroidal antiinflammatory drug therapy. Braun J, van der Horst-Bruinsma IE, Huang F, Burgos-Vargas R, Vlahos B, Koenig AS, Freundlich B. Author information: (1)Inflammation Disease Area, Specialty Care Business Unit, Pfizer Inc., 500 Arcola Road, Collegeville, PA 19422, USA. These findings are in contrast to those in studies showing the established efficacy and rapid adoption of TNF inhibitors to treat active AS. Our health evidence - how can it help you. This outcome was not measured in the studies. Learn about our remote access options, National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, Bethesda, Maryland. Even though ankylosing spondylitis is a type of arthritis, it only affects about 1 in 1000 people. - People who took sulfasalazine rated their pain to be 47 on a scale of 0 to 100 after 3 to 36 months. 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. Learn more. Bath ankylosing spondylitis function index (BASFI), Bath ankylosing spondylitis metrology index (BASMI), Total number of withdrawals due to adverse events. 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. We use cookies to improve your experience on our site. Number of times cited according to CrossRef: National pharmacological treatment trends for ankylosing spondylitis in South Korea: A national health insurance database study. The full text of this article hosted at iucr.org is unavailable due to technical difficulties. DOI: 10.1002/14651858.CD004800.pub3, Copyright © 2020 The Cochrane Collaboration. And I remember the day I found out all too well. 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. OBJECTIVE: To evaluate the efficacy and toxicity of sulfasalazine (SSZ) for the treatment of ankylosing spondylitis (AS). 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