Rapid alleviation of signs and symptoms of rheumatoid arthritis with intravenous or subcutaneous administration of adalimumab in combination with methotrexate.

摘要: Objective: This randomized, placebo‐controlled, double‐blind, Phase 1 study assessed the magnitude, onset, and duration of response with intravenous (i.v.) subcutaneous (s.c.) adalimumab (Humira®, Abbott Laboratories) combined methotrexate (MTX) in patients active rheumatoid arthritis (RA) despite previous MTX therapy.Methods: Fifty‐four were randomized to two injections i.v. or s.c. (1 mg/kg) placebo while continuing on (mean dose, 15.7 mg/week). Dosing intervals determined by European League Against Rheumatism (EULAR) criteria, allowed range from 3 months. Efficacy was mainly using EULAR criteria American College Rheumatology (ACR) criteria.Results: Moderate achieved at least once within 29 days after first injection 83% 61% receiving respectively, compared 44% for [probability (p)≤0.05 adalimumab...