HERNE, Germany— Although sulfasalazine (SSZ) is no better than placebo for the treatment of undifferentiated spondyloarthritis (SpA), new research suggests that this disease modifying antirheumatic drug (DMARD) is more effective than placebo among patients with inflammatory back pain who do not have peripheral arthritis. Jürgen Braun, MD, the medical director of the Rheumazentrum Ruhrgebiet in Herne, Germany, reports the findings in the Annals of Rheumatic Diseases.¹

Effective treatment is needed to prevent early SpA symptoms from progressing to ankylosing spondylitis (AS) in patients who do not qualify for tumor necrosis factor (TNF)-inhibitors under the restrictions used in several European national health programs. "Our data suggest that it may make sense in some patients to try SSZ for early SpA with inflammatory back pain (IBP)," Dr. Braun tells CIAOMEd. "I think in patients with early SpA and relatively mild disease, [SSZ] can be worthwhile."

In the study, 230 patients with IBP and a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >3 received either SSZ 2x1 g/day or placebo for 6 months. The mean BASDAI dropped by 3.7 among patients taking SSZ and 3.8 among those in the placebo arm. Spinal pain, physical function, and inflammation also decreased in both groups, the study showed. Patients with IBP and no peripheral arthritis, however, showed greater improvements in BASDAI score with SSZ than did patients who received placebo. Moreover, spinal pain and morning stiffness improved in patients with IBP and no peripheral arthritis who received placebo.

"I think we need much more prospective cohort data on early disease stages, and the influence of biologics including the prevention of structural changes," Dr. Braun said.

Niche for SSZ

For physicians in the US and other countries with less restricted use of TNF inhibitors, SSZ's role in undifferentiated SpA is "limited," Eric Matteson, MD, professor of medicine at the Mayo Clinic in Rochester, Minnesota, told CIAOMed. "Although this study does suggest—somewhat to my surprise—that it is indeed helpful for a substantial proportion of patients [with IBP who did not have peripheral arthritis]." Dr. Matteson said that he would not use SSZ to treat undifferentiated SpA.  "The advent of biologics was a major breakthrough for the management of these patents," he said.
 
Philip J. Mease, MD, of the department of internal medicine at the Swedish Medical Center and Rheumatology Associates in Seattle, Washington, told CIAOMed that the new findings "don't add much to our overall impression of the use of SSZ, which in the treatment of established AS has not shown statistically significant efficacy compared with placebo in the management of the spine aspect of AS." He added that it has had some impact on peripheral arthritis.

"This [study] was a foray into finding out if there might be better results in an early, undifferentiated population of SpA patients [and] the results were not dramatic and a bit surprising that it was the subset of patients without peripheral arthritis who had better results," he said, adding that, since the overall findings were not dramatic and the numbers were small, it is not clear that the data are meaningful.

Do the Findings Affect Practice?

"This does not significantly change my current practice, which is to use SSZ first, before an anti-TNF, as insurance companies typically require at least one DMARD to be used," Dr. Mease said. "Also, some patients get a bit wide-eyed at the idea of jumping right to an injectable so a 4- to 6- month trial of  SSZ is not a bad way to ease them into the idea of using something stronger if their symptoms do not abate or become more active."

CIAOMed editorial board member Vibeke Strand, MD, of Stanford University School of Medicine in Palo Alto, California, said that "the findings are really not of surprise. Generally I don't use SSZ in any patients because of limited efficacy and poor tolerability."

Martin Bergman, MD, chief of rheumatology at Taylor Hospital in Ridley Park, Pennylvania, agreed with Dr. Strand. "In general, I don't use SSZ for IBP," he said  But, "the results of the study, while preliminary, might encourage me to use SSZ in a patient with IBP for whom an anti-TNF agent was either ineffective, unaffordable, or contraindicated."

Reference

1. Braun J, Zochling J, Baraliakos X, et al. Efficacy of sulfasalazine in patients with inflammatory back pain due to undifferentiated spondyloarthritis and early ankylosing spondylitis: a multicentre randomized controlled trial. Ann Rheum Dis. 2006;65:1147-1153.