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

Abstract

Aim: To evaluate efficacy of sulfasalazine for axial ankylosing spondylosis.

Methods: 67 patients fulfilling the inclusion criteria were included and randomized into treatment and placebo group.

Results: Mean age in treatment group was 31 years (range: 17-60); placebo group was 30 years (18-46). Mean disease duration treatment group 8.4 years (range: 3-25) and placebo group was 8.3 years (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 ≤ 4 years. 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 ≤ 4 years.

Conclusion: Sulfasalazine is effective in axial AS esp. in younger patients (< 25 years), disease duration < 4 years at the time of initiation of treatment and high disease activity (BASDAI > 7, CRP > 50 mg/L). This signifies early diagnosis and treatment is very important in management and prevention of disease progression.

Keywords: ankylosing spondylitis; drug treatment.