Reduced Humira Formulation Produces Less Injection Site Pain

A reduced formulation of Humira (adalimumab; Abbvie Inc) for the treatment of rheumatoid arthritis produced less adverse events, specifically injection site pain, when compared with the current formulation, according to data presented at the EULAR 2016 Congress.

“A new 40 mg/0.4 mL formulation of adalimumab was developed that has fewer excipients, a smaller volume, and a delivery presentation with a smaller gauge needle than the current 40 mg/0.8 mL formulation,” Peter Nash, MD, professor of the department of medicine at the University of Queensland, Australia, and colleagues wrote. “[The reduced formulation] was well tolerated and associated with less injection site–related pain than the 40 mg/0.8 mL adalimumab formulation.”

The researchers conducted two identically designed phase 2 trials. Sixty-two patients in the first study and 60 patients in the second study were randomized to receive either the normal formulation or the reduced formulation at visit 1; then, after 1 to 2 weeks, patients received the alternate formulation.  Injection site pain was evaluated using a pain visual analog scale (VAS) and the Draize scale, immediately after injection and then 15 minutes after injection. 

Results from both studies showed that injection site pain was significantly reduced when the 40 mg/0.4 mL formulation was used over the 40 mg/0.8 mL formulation. When the data were pooled, the mean difference was statistically significant, with a median percentage difference of -84%.  

The researchers noted that most other endpoints were comparable between the two formulations, including tolerability and safety.

The study was conducted with funding, design input, and researcher assistance from Abbvie. —David Costil