A randomized controlled trial to study the efficacy of sulfasalazine for axial disease in ankylosing spondylitis.

Abstract

To evaluate efficacy of sulfasalazine for axial ankylosing spondylosis. 67 patients fulfilling the inclusion criteria were included and randomized into treatment and placebo group. Mean age in treatment group was 31years (range: 17-60); placebo group was 30years (18-46). Mean disease duration treatment group 8.4years (range: 3-25) and placebo group was 8.3years (3-19). Clinically significant improvement in ASDAS (ΔASDAS>1.1) seen in 15.1% of placebo and 67.7% in treatment group (P=0.001). The mean±SD of ΔASDAS in treatment group was 1.33±0.38 (range: 0.9-2.3) where as in placebo group it was 0.748±0.23 (0.4-1.3) with significant difference (P=0.00). The mean±SD of ΔBASDAI of treatment group was 3.29±0.97 (range: 1.5-5.5) placebo group was 1.47±0.99(0.5-4.5) with P=0.00. The mean value of ΔBASMI of drug group 3.29±0.97(range: 1.8-5) and of placebo group was 1.47±0.99 (0.6-3.7) with (P=0.00). Clinical improvenent in (ΔASDAS>1.1) was observed in patients of both the groups with disease duration ≤4years. However it was significantly higher in treatment group (P=0.04). Highly significant improvement in (ΔASDAS>2) was observed in two of five patients in treatment group with disease duration ≤4years. Sulfasalazine is effective in axial AS esp. in younger patients (<25years), disease duration <4years at the time of initiation of treatment and high disease activity (BASDAI>7, CRP>50mg/L). This signifies early diagnosis and treatment is very important in management and prevention of disease progression.