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New adalimumab formulation associated with less injection site-related pain

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Results recently presented at the EULAR Annual Congress showed a new formulation of adalimumab at 40 mg/0.4 mL in the treatment of rheumatoid arthritis was associated with less injection site-related pain compared with the current formulation of adalimumab at 40 mg/0.8 mL.

In two identically designed, two-period crossover studies, researchers randomly assigned 64 patients in study one and 61 patients in study two with rheumatoid arthritis (RA) to receive either 40 mg/0.8 mL adalimumab or 40 mg/0.4 mL adalimumab at the first visit. Patients then received the other formulation at their second visit 1 week to 2 weeks after the first injection, according to researchers. With a primary endpoint of immediate pain after injection, researchers evaluated pain VAS and the Draize scale outcomes immediately after injection and 15 minutes after injection.

Results showed patients who received 40 mg/0.4 mL of adalimumab had significantly lower immediate pain after injection in both studies vs. patients who received the 40 mg/0.8 mL formulation. Researchers found statistically significant and clinically relevant mean differences on the VAS for the pooled data, with a median percent reduction of –84%. According to results, 40 mg/0.4 mL of adalimumab was favored by most other endpoints in both studies. The tolerability and safety profiles of 40 mg/0.4 mL adalimumab were also consistent with the 40 mg/0.8 mL formulation, researchers noted.

“The results of the two phase 2, randomized, crossover studies in patients with RA demonstrated that the 40 mg/0.4 mL formulation of Humira is associated with less injection site-related pain compared with the currently available formulation (Humira 40 mg/0.8 mL),” Peter Nash, MD, from the University of Queensland, Queensland, Australia, told Healio.com/Rheumatology. “Although this study was conducted in patients with RA, similar outcomes would be expected in other immune-mediated inflammatory diseases for which Humira is approved.” – by Casey Tingle

Reference:

Nash P, et al. Abstract #FRI0187. Presented at: EULAR Annual Congress; June 8-11, 2016; London.

Disclosures: Nash received grant or research support from and is on the speakers bureau for AbbVie. Please see the full abstract for a list of all other authors’ relevant financial disclosures.