Abstract
A Prospective Double Blind Placebo Controlled Trial of Combination Disease Modifying Antirheumatic Drugs vs. Monotherapy (Sulfasalazine) in Patients with Inflammatory Low Backache in Ankylosing Spondylitis and Undifferentiated Spondyloarthropathy
Highlights
Seronegative Spondyloarthropathies (SpA) refer to a group of chronic inflammatory disorders of unknown etiology
The subgroups which come under this terminology includes: Ankylosing Spondylitis (AS), Psoriatic Arthritis, Reactive Arthritis, Inflammatory bowel disease associated arthritis and Undifferentiated Spondyloarthritis (USpA)
Double blind, placebo-controlled study, we compared the efficacy of SSZ monotherapy versus combination of DMARDs including SSZ, MTX and HCQ, for inflammatory Chronic Low Back Ache (CLBA) in relatively early disease of AS/ USpA patients, refractory to NSAID therapy
Summary
Patients with AS/UspA with disease duration ≤ 8 years, IBP of atleast 6 months duration, and BASDAI ≥ 4 or early morning stiffness ≥ 1 hour despite NSAID therapy for 6 weeks were included. Patients were initiated on SSZ with either combination DMARD [MTX (10 mg escalated by 2.5 mg every week up to 20 mg/week) and HCQS 200 mg/day] or SSZ Monotherapy group [placebo MTX and placebo HCQS]. ASAS20 response was assessed at baseline and at the end of 6 months
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