Background 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.
Objectives Evaluate injection site–related pain, safety, and tolerability of the new and current formulations of adalimumab in patients with rheumatoid arthritis (RA).
Methods In 2 identically designed, phase 2, randomized, single-blind, 2-period crossover 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 minutes postinjection; the primary endpoint was immediate pain after injection.
Results Sixty-four and 61 patients were randomized in Studies 1 and 2, respectively. Both studies found significantly lower immediate pain after injection for the 40 mg/0.4 mL versus the 40 mg/0.8 mL formulation (Table). The mean difference on the VAS for the pooled data (−2.48 cm) was statistically significant (P<0.001) and clinically relevant; the median percent reduction was –84%. Most other endpoints in both studies favored the 40 mg/0.4 mL formulation (Table), and its tolerability and safety profiles were consistent with 40 mg/0.8 mL adalimumab (data not shown).
Conclusions A 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.
Acknowledgement AbbVie funded the study; contributed to its design; and was involved in collection, analysis, and interpretation of the data and in writing, review, and approval of the abstract. All authors contributed to and maintained control over final content. Katie Groschwitz, PhD, of Complete Publication Solutions, LLC, provided medical writing support. The authors would like to thank Monika Höbel and Hui Ding, employees of AbbVie, for statistical programming support.
Disclosure of Interest P. Nash Grant/research support from: AbbVie, Speakers bureau: AbbVie, J. Vanhoof Grant/research support from: AbbVie, Pfizer, and Roche, S. Hall: None declared, R. Tarzynski-Potempa Employee of: AbbVie, K. Unnebrink Employee of: AbbVie, A. Cividino Grant/research support from: AbbVie, Pfizer, Celgene, Takeda, Roche and UCB; support for the AbbVie Chair in Education in Rheumatology
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