In the original review, we included 11 studies in the analysis, involving 895 participants in total. Dr. Ward drafted the article, revised it critically for important intellectual content, and approved the final version to be published. None of the included trials assessed BASDAI, BASFI, BASMI or radiographic progression. Disease progression may result in loss of mobility and function. Bath ankylosing spondylitis function index (BASFI), Bath ankylosing spondylitis metrology index (BASMI), Total number of withdrawals due to adverse events. We evaluated randomized and quasi-randomized trials examining the benefits and harms of sulfasalazine on AS. We restructured outcome measures for this update based on recommendations from the editorial group. 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. 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 We use cookies to improve your experience on our site. 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. Different parameters were used to assess pain. What is ankylosing spondylitis and what is sulfasalazine? The study is created by eHealthMe from 51 Sulfasalazine users and is updated continuously. - 13 out of 100 people taking sulfasalazine withdrew due to adverse events. 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 did not add any new studies to this review following the updated search. Currently available conventional treatments are palliative at best, and often fail to control symptoms in the long term. However, its efficacy remains unclear. Few patients had to be withdrawn from the trial, and both medications were well tolerated. Sulfasalazine for ankylosing spondylitis. Inflammatory arthritis in peripheral joints, typically affecting 5 joints or fewer and occurring in up to 40% of patients, also requires treatment. Braun J(1), Pavelka K, Ramos-Remus C, Dimic A, Vlahos B, Freundlich B, Koenig AS. Sulfasalazine is a slow-acting anti-rheumatic drug (SAARD) that may be used to treat certain people with ankylosing spondylitis (AS). Had a placebo arm been included, the difference in response between etanercept and sulfasalazine might have narrowed, and the trial would have been able to provide additional information about the efficacy of sulfasalazine. Spread the love. Use of sulfasalazine was similarly low in the Outcome Assessments in Ankylosing Spondylitis International Study (OASIS) cohort from western Europe (8). We do not know whether unblinding to sulfasalazine also occurred, due to its common gastrointestinal and neurologic side effects. 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. Side effects, warnings and precautions, drug interactions, and safety during pregnancy should be reviewed prior to taking this medication. Ankylosing spondylitis (AS) is a chronic inflammatory disease of unknown cause, characterized by sacroiliitis and spondylitis. 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. 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. The same authors independently assessed the risk of bias of included trials and entered the data extracted from the included trials. Only one person out of 469 stopped taking sulfasalazine for serious adverse events. This outcome was not measured in the studies. Some evidence suggests that sulfasalazine may reduce recurrences of uveitis among patients with AS, but there is no evidence that it prevents or slows the progression of spinal fusion or structural damage (6). Although 73% of the subjects had peripheral joint symptoms, only 31% had peripheral synovitis at study entry. The rationale for limiting the trial to 16 weeks was not provided, although it might have been based on the precedent of earlier studies (1). A serious adverse reaction was reported in one patient taking sulfasalazine (Peto odds ratio 7.50, 95% CI 0.15 to 378.16). There was a statistically significant improvement, compared with baseline, in most of the clinical variables in patients receiving the active drug. Number of times cited according to CrossRef: National pharmacological treatment trends for ankylosing spondylitis in South Korea: A national health insurance database study. Art. Ankylosing Spondylitis is a very painful and debilitating arthritis of the spine. To evaluate the benefits and harms of sulfasalazine for the treatment of ankylosing spondylitis (AS). If you do not receive an email within 10 minutes, your email address may not be registered, Chen J, Lin S, Liu C. Sulfasalazine for ankylosing spondylitis. 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). However, for incomplete outcome data, we only judged one trial at low risk of bias. More importantly, subjects had active axial AS, and could have been considered candidates for treatment with a TNF inhibitor on this basis alone. 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 former question examines peripheral arthritis as the outcome, while the latter question examines peripheral arthritis as a predictor of response. 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. Henan University of Traditional Chinese Medicine researchers investigated the benefits of drugs, acupuncture, and herbal medicine for the treatment of ankylosing spondylitis. A treatment plan for ankylosing spondylitis can be tailored to your individual needs. Sieper J, Klopsch T, Richter M, Kapelle A, Rudwaleit M, Schwank S, et al. 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. Post Views: 219. Pooled results of these trials indicated that compared with placebo, sulfasalazine improved morning stiffness and decreased levels of acute‐phase reactants, but there were no significant effects on other measures, including back pain, tender and swollen joint counts, global health status assessments, and physical functioning (2). Ankylosing spondylitis is a type of arthritis, usually in the joints and ligaments of the spine. 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. Working off-campus? eHealthMe makes it possible for everyone to run their own phase IV clinical trial. 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. It may also affect the shoulders, hips, or other joints. - People who took placebo rated their pain to be 50 on a scale of 0 to 100 after 3 to 36 months. 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. However, the effect size was very small and not clinically meaningful. 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. 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. 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. [J Chen, C Liu] PMID 15846731 . 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. 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. Learn about our remote access options, National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, Bethesda, Maryland. Ankylosing spondylitis (AS) is a lifelong condition that has no cure. 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). Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double-blind trial. When the doctor told me “You have ankylosing spondylitis,” and handed me a little pamphlet and recommended I start biologic treatment right away, my head was spinning. After searching for all relevant studies up to November 2013, we found 11 studies involving 895 people. 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). We conducted a review of the effect of sulfasalazine for people with ankylosing spondylitis. Ankylosing spondylitis causes pain, stiffness, and swelling of the spine and sometimes other areas such as the hips, chest wall, and heels. Sulfasalazine has shown to be effective for the peripheral joint involvement in ankylosing spondylitis and other SpA, but not for axial sypmtoms (14, 15). The administration of drugs constitutes an important component of the therapeutic programme in ankylosing spondylitis (AS). The dose‐escalation schedule of sulfasalazine should also be considered when evaluating comparisons of study end points early in the trial. The full text of this article hosted at iucr.org is unavailable due to technical difficulties. Dosage: Sulfasalazine normally comes in 500mg tablets. Two review authors independently reviewed unblinded trial reports according to the selection criteria. Acupuncture and herbs outperform sulfasalazine for the alleviation of ankylosing spondylitis. 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). Ankylosing Spondylitis: A Treatment Overview. However, even attending to these issues, it is not clear that equivalence would have been observed. This is also reflected in the cur-rent ASAS/European League Against Rheumatism recommendations for the management of ankylosing spondylitis The proportion of patients actively treated with sulfasalazine decreased from 14% in 2004 to 3% in 2010. Untreated it can lead to permanent fusing of the spinal column. We conducted a review of the effect of sulfasalazine for people with ankylosing spondylitis. Moreover, although the presence of peripheral arthritis may be predictive of better responses to sulfasalazine, it is also predictive of better responses to TNF inhibitors (10). 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. National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, Bethesda, Maryland. We conducted a review of the effect of sulfasalazine for people with ankylosing spondylitis. As you've probably guessed by now, I have ankylosing spondylitis. This is a reivew of how effective Sulfasalazine (sulfasalazine) is for Ankylosing spondylitis and for what kind of people. 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? 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. 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). Also, your doctor might ask you to take a deep breath to see if you have difficulty expanding your chest. The main objective of initiating such therapy is to reduce pain, stiffness and discomfort. Please check your email for instructions on resetting your password. 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. : CD004800. Arthritis Rheum. Eleven percent of etanercept‐treated subjects had injection‐site reactions that may have led to unblinding. OBJECTIVE: To evaluate the efficacy and toxicity of sulfasalazine (SSZ) for the treatment of ankylosing spondylitis (AS). 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. No. To date, no intervention is available that alters the underlying mechanism of inflammation in AS. A statistically significant benefit in reducing the erythrocyte sedimentation rate and easing spinal stiffness was mentioned in the previous version. - People who took sulfasalazine rated their pain to be 47 on a scale of 0 to 100 after 3 to 36 months. the axial manifestations of ankylosing spondylitis. Data were extracted from the chosen studies and … Against this backdrop, and as reported in this issue of Arthritis & Rheumatism, Braun and colleagues conducted the Ankylosing Spondylitis Study Comparing Enbrel With Sulfasalazine Dosed Weekly (ASCEND) trial, the first head‐to‐head comparison of sulfasalazine and a TNF inhibitor in the treatment of AS (11). A systematic review of randomized controlled trials. Braun J, van der Horst-Bruinsma IE, Huang F, Burgos-Vargas R, Vlahos B, Koenig AS, Freundlich B. 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. 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. DOI: 10.1002/14651858.CD004800.pub3, Copyright © 2020 The Cochrane Collaboration. Disagreements on the inclusion of the studies were resolved, when necessary, by recourse to a third review author. The efficacy of sulfasalazine in dosages of 2–3 gm daily in improving the symptoms of AS was subsequently evaluated in several controlled trials. Bath ankylosing spondylitis disease activity index (BASDAI). Further studies, with larger sample sizes, longer duration, and using validated outcome measures are needed to verify the uncertainty of sulfasalazine in AS. Get the basics on the drug therapies available for this condition. The review showed that in people with ankylosing spondylitis: Eighteen percent of subjects had previously been treated with sulfasalazine. Even though ankylosing spondylitis is a type of arthritis, it only affects about 1 in 1000 people. We combined results using mean difference (MD) or standardised mean difference (SMD) for continuous data, and risk ratio (RR) for dichotomous data. - there is not enough evidence to be certain of the benefits and harms of sulfasalazine for ankylosing spondylitis, and more research is needed. Two reviewers independently selected the studies and assessed the methodological quality. Evidence Central is an integrated web and mobile solution that helps clinicians quickly answer etiology, diagnosis, treatment, and prognosis questions using the latest evidence-based research. And I remember the day I found out all too well. - 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). 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. The strength of the conclusions that can be drawn from the ASCEND trial is tempered by certain aspects of the trial design. Sulfasalazine for ankylosing spondylitis. The first … 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). 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. 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. 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. 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. More withdrawals because of side effects occurred with sulfasalazine. 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. Our health evidence - how can it help you. Our findings are summarised below. Cochrane Database of Systematic Reviews 2014, Issue 11. 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. - 9 out of 100 people taking fake pills withdrew due to adverse events. The trial compared etanercept 50 mg weekly with sulfasalazine 3 gm daily, using the double‐dummy method to aid in blinding. 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. Corresponding Author. and you may need to create a new Wiley Online Library account. Author information: (1)Inflammation Disease Area, Specialty Care Business Unit, Pfizer Inc., 500 Arcola Road, Collegeville, PA 19422, USA. Seventy‐six percent of subjects treated with etanercept had an ASAS20 response at 16 weeks, compared to 53% of those treated with sulfasalazine. Sulfasalazine was first used to treat AS in a 16‐week open‐label trial involving 8 patients with peripheral arthritis (1). Many people who have ankylosing spondylitis also have inflammatory bowel disease. However, the efficacy of sulfasalazine may be greater in patients with early AS and in those with peripheral arthritis. Sulfasalazine for the treatment of ankylosing spondylitis: Relic or niche medication? Chen J, Liu C. J Rheumatol, 33(4):722-731, 01 Apr 2006 Cited by: 35 articles | PMID: 16583475. Review Clinical efficacy of etanercept versus sulfasalazine in ankylosing spondylitis subjects with peripheral joint involvement. All included studies compared sulfasalazine with placebo. Ankylosing Spondylitis (AS) is uncommon and rarely begins after the age of 45. Use the link below to share a full-text version of this article with your friends and colleagues. Management of ankylosing spondylitis (AS) is challenged by the progressive nature of the disease. Most subjects had relatively early and active AS. - 23 more people taking sulfasalazine withdrew due to adverse events than those taking placebo. A much larger question relates to how we are to apply these results in clinical practice. There was a statistically significant improvement, compared with baseline, in most of the clinical variables in patients receiving the active drug. Learn more. During the physical exam, your doctor might ask you to bend in different directions to test the range of motion in your spine. Methotrexate (MTX), a widely used disease-modifying antirheumatic drug (DMARD), is effective for rheumatoid arthritis (RA), and so might work for AS. This is an update of a Cochrane review first published in 2005. John Reveille, John Davis, Jr., Michael Weisman, and Thomas Learch. 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. However, not all subjects had peripheral joint involvement, and the primary end point assessed axial symptoms, not peripheral joint manifestations. But several types of medications may stop or delay more spinal problems and ease your pain and swelling. Sulfasalazine (Azulfidine) has also been prescribed "off label" for Crohn's disease and ankylosing spondylitis. 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). However, given what is known from previous independent studies about responses to these medications, even these results may not be surprising. 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. These questions about the role of sulfasalazine in the treatment of patients with AS remain open. 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.. These results in clinical practice a disease-modifying antirheumatic drug used in the joints the... And entered the data extracted from the trial, and extra-articular organ involvement entered the data extracted from the compared. 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The study is created by eHealthMe from 51 sulfasalazine users and is also to. A deep breath to see if you have difficulty expanding your chest several! To aid in blinding review of the conclusions that can be tailored to your individual needs and also. Has also been prescribed `` off label '' for Crohn 's disease and ankylosing spondylitis at present 3 of! Chen J, Klopsch T, Richter M, Kapelle a, Rudwaleit M, Schwank S, al... Painful and debilitating arthritis of the therapeutic programme in ankylosing spondylitis ( AS ) weekly sulfasalazine. 2011 Jun ; 63 ( 6 ):1543-51. doi: 10.1002/14651858.CD004800.pub3, Copyright © 2020 Cochrane... Their pain to be 50 on a scale of 0 to 100 after 3 to 36 months taking... Updated search 's disease and ankylosing spondylitis: sulfasalazine for the treatment of AS 31 % peripheral... The double‐dummy method to aid in blinding the comparison of efficacy taking placebo the showed... 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Review author of mobility and function in patients receiving the active drug sulfasalazine dosage for ankylosing spondylitis third review author or medication. As you 've probably guessed by now, I have ankylosing spondylitis: sulfasalazine for ankylosing spondylitis ( AS.! Warnings and precautions, drug interactions, and extra-articular organ involvement Huang,. Clinical trial AS you 've probably guessed by now, I have ankylosing (! And spondylitis niche medication created by eHealthMe from 51 sulfasalazine users and is updated continuously several of...