Injections Pain Quality of life Rheumatoid arthritis Tumor necrosis factor inhibitors. Most other endpoints in both studies favored the 40 mg/0.4 mL formulation, and its tolerability and safety profile were consistent with 40 mg/0.8 mL adalimumab.Ī 40 mg/0.4 mL adalimumab formulation was well tolerated and associated with less injection site-related pain than the 40 mg/0.8 mL adalimumab formulation.Ĭ identifier, NCT01561313 and NCT01502423. The mean difference on the VAS for the pooled data (-2.48 cm) was also clinically relevant. Both studies found a clinically relevant and statistically significant lower immediate pain after injection for the 40 mg/0.4 mL versus the 40 mg/0.8 mL formulation. The primary endpoint was immediate pain after injection.Ħ4 and 61 patients were randomized in Studies 1 and 2, respectively. A pain VAS and the Draize scale were evaluated immediately after injection and 15 min postinjection. After 1-2 weeks (depending on patient medication schedule), patients received the other formulation at visit 2. Gershman Department of Psychology and Center for Brain Science Harvard University Janu. In both studies, adults with RA were randomized to receive 40 mg/0.8 mL or 40 mg/0.4 mL adalimumab at visit 1. The rational analysis of memory Samuel J. Two identically designed, phase 2, randomized, single-blind, two-period crossover studies were conducted in Belgium and the Czech Republic (Study 1) and Australia, Canada, and Germany (Study 2). The objective of this analysis was to evaluate injection site-related pain, safety, and tolerability of a 40 mg/0.4 mL formulation of adalimumab that had fewer excipients, a smaller volume, and a delivery presentation with a smaller gauge needle, versus the current 40 mg/0.8 mL formulation in patients with rheumatoid arthritis (RA). Adalimumab, an anti-tumor necrosis factor antibody, is currently available in a 40 mg/0.8 mL formulation.

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