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In rheumatoid arthritis management, Tofacitinib in combination with Methotrexate exhibits significant efficacy.
Tofacitinib in combination with Methotrexate emerges as an excellent approach to manage rheumatoid arthritis condition among people with active RA and Methotrexate inadequate response (MTX‐IR), revealed by a recently published 24-Month Phase 3 ORAL Scan Study.
Participants were divided into 4:4:1:1 to receive 5 or 10 mg Tofacitinib twice daily (BID) or placebo→5 or 10 mg Tofacitinib BID, with stable, background MTX. The non-responders obtained placebo advanced to Tofacitinib at Month 3 were and remaining participants at month six. Structural progression, clinical efficacy and treatment‐emergent adverse events were determined. The full analysis set with non‐responder or observed imputation with no preferment penalty for clinical effectiveness and imputation by linear extrapolation for structural progress was used to perform the analysis.
A total of 797 participants were operated, out of which 539 accomplished the 24-month treatment. Both Tofacitinib doses exhibited similar proportions of patients achieving DAS28‐4(ESR)‐defined remission or low disease activity, Simplified Disease Activity Index, ACR20/50/70 responses, Boolean remission, Health Assessment Questionnaire Disability Index, and Clinical Disease Activity Index throughout the 12-24 months. The safety concerns were also similar in frequency and type for both doses. Minimal structural destruction was noticed at 12 and 24 months. All these findings govern that 5 or 10 mg Tofacitinib BID with MTX shows significant radiological and clinical efficacy which sustained for Months 12‐24.
Arthritis & Rheumatology
Tofacitinib in Combination with Methotrexate in Patients with Rheumatoid Arthritis: Clinical Efficacy, Radiographic and Safety Outcomes from the 24-Month Phase 3 ORAL Scan Study.
Désirée van der Heijde et al.
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