Randomized Crossover Comparison of Injection Site Pain with 40 mg-0.4 or 0.8 mL Formulations of Adalimumab in Patients with Rheumatoid ArthritisReportar como inadecuado

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Rheumatology and Therapy

, Volume 3, Issue 2, pp 257–270

First Online: 18 August 2016Received: 09 June 2016


IntroductionAdalimumab, an anti-tumor necrosis factor antibody, is currently available in a 40 mg-0.8 mL formulation. 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.

MethodsTwo 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. In both studies, adults with RA biologic-naive or current users of 40 mg-0.8 mL adalimumab with an average injection site-related pain rating ≥3 cm on a visual analog scale VAS; 0–10 cm were randomized to receive 40 mg-0.8 mL or 40 mg-0.4 mL adalimumab at visit 1. After 1–2 weeks depending on patient medication schedule, patients received the other formulation at visit 2. A pain VAS McGill Pain Questionnaire MPQ-SF and the Draize scale were evaluated immediately after injection and 15 min postinjection. The primary endpoint was immediate pain after injection.

Results64 and 61 patients were randomized in Studies 1 and 2, respectively. 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 mean difference on the VAS for the pooled data −2.48 cm was also clinically relevant. 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.

ConclusionA 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.

Trial registrationClinicalTrials.gov identifier, NCT01561313 and NCT01502423.


KeywordsInjections Pain Quality of life Rheumatoid arthritis Tumor necrosis factor inhibitors Enhanced contentTo view enhanced content for this article go to http:-www.medengine.com-Redeem-FAE4F060049D77A7.

Electronic supplementary materialThe online version of this article doi:10.1007-s40744-016-0041-3 contains supplementary material, which is available to authorized users.

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Fuente: https://link.springer.com/

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