Comparison of sulfasalazine and placebo for the treatment of axial and peripheral articular manifestations of the seronegative spondylarthropathies -A department of veterans affairs cooperative study

Objective. To determine if the peripheral articular manifestations of the s eronegative spondylarthropathies (SNSA) respond differently than the axial manifestations to treatment with sulfasalazine (SSZ), Methods. This is a reanalysis of a previously reported series of randomized , double-blind, placebo-controlled, multicenter trials comparing the effect s of SSZ, 2,000 mg/day, and placebo on the axial and peripheral articular m anifestations of ankylosing spondylitis (AS), psoriatic arthritis (PsA), an d reactive arthritis (ReA; Reiter's syndrome). Patients were classified as treatment responders on the basis of meeting predefined improvement criteri a in 4 outcome measures: namely, patient and physician global assessments i n all patients, morning stiffness and back pain in patients with axial mani festations, and joint pain/tenderness scores and joint swelling scores in p atients with peripheral articular manifestations. Results. Six hundred nineteen SNSA patients (264 AS, 221 PsA, and 134 ReA) were studied, One hundred eighty-seven of these patients had only axial man ifestations of their disease, while 432 patients had peripheral articular m anifestations. Of the patients with axial disease, 40.2% of the SSZ group a nd 43.3% of the placebo group met the predefined response criteria (P = 0.6 7), Of the peripheral articular group, 59.0% of the SSZ-treated patients an d 42.7% of the placebo-treated patients showed a response (P = 0.0007). Conclusion. In a large group of affected individuals, the response of SNSA patients to SSZ appears to be related to the articular manifestations of th eir disease. These data demonstrate that the axial and peripheral articular manifestations of SNSA respond differently to treatment with SSZ, In SNSA patients with persistently active peripheral arthritis, SSZ is safe, well t olerated, and effective.