Randomized Crossover Comparison of Injection Site Pain with 40 mg-0.4 or 0.8 mL Formulations of Adalimumab in Patients with Rheumatoid ArthritisReport as inadecuate




Randomized Crossover Comparison of Injection Site Pain with 40 mg-0.4 or 0.8 mL Formulations of Adalimumab in Patients with Rheumatoid Arthritis - Download this document for free, or read online. Document in PDF available to download.

Rheumatology and Therapy

, Volume 3, Issue 2, pp 257–270

First Online: 18 August 2016Received: 09 June 2016

Abstract

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.

FundingAbbVie.

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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