Abstract Background/Aims Emerging evidence suggests that inflammatory cytokines like TNF play a critical role in osteoarthritis (OA) pathogenesis and symptom persistence. This ADAKOA study evaluates the efficacy and safety of subcutaneous adalimumab (ADA) versus intra-articular corticosteroid in inflammatory knee OA patients with inadequate response to conventional therapies. Methods This open-label, randomised controlled trial was conducted at the Department of Clinical Immunology and Rheumatology, IPGMER , Kolkata, (India) from February 2024 to April 2025 after IEC approval and CTRI registration. A total of 74 symptomatic primary inflammatory knee osteoarthritis patients (age 40-75) were randomised 1:1. The primary endpoint was the 12-week change in WOMAC pain (0-100), testing the superiority of monthly subcutaneous adalimumab over a single intra-articular triamcinolone injection in moderate-severe inflammatory knee OA; secondary endpoints included the week-12 OARSI/OMERACT responder rate, changes in WOMAC stiffness and function at weeks 6 and 12, the week-6 change in WOMAC pain, and patient global assessment (0-100) at weeks 6 and 12. Results Seventy-four patients met the inclusion/exclusion criteria and were randomised to Group A (adalimumab 40 mg SC every 4 weeks ×3; n = 37) or Group B (single intra-articular triamcinolone 40 mg; n = 37).At baseline, the 74 participants (37 per arm) were well balanced: mean age ∼52 vs 53 years, 80-87% female, and ∼73-76% KL grade 3. Disease duration was predominantly 1-5 years (92% vs 76%). No between-group differences were statistically significant (all p 0.05). Although the trial did not meet its primary endpoint of 12-week WOMAC pain superiority, both arms showed significant within-group improvements in WOMAC pain, stiffness, and function, as well as patient global assessment. The primary and secondary outcomes are summarised in Table 1. Conclusion Intraarticular triamcinolone provided rapid but short-lived symptom relief in inflammatory knee osteoarthritis, whereas subcutaneous adalimumab demonstrated a slower onset yet more sustained improvement in pain, stiffness, function, and patient global assessment. Disclosure I. Haque: None. B. Ghosh: None. P. Ghorai: None. P. Ghosh: None.
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