Background/Purpose: This study aimed to demonstrate that there were no clinically meaningful differences between adalimumab-aqvh, a US Food and Drug Administration–approved biosimilar, and adalimumab in patients with moderate-to-severe chronic plaque psoriasis. Adalimumab is a biologic drug used to treat many inflammatory diseases such as plaque psoriasis, but the high cost of the drug may be a barrier to treatment. Biosimilars are biologic drugs that are highly similar in purity, potency, efficacy, and safety to the reference biologic and are available at lower costs.

Methods: In this phase III, double-blind, institutional review board–approved study (NCT02489227), patients with psoriasis underwent 3 periods of treatment. During period 1, patients were randomly assigned to receive adalimumab-aqvh or adalimumab; during period 2, they switched to or remained on adalimumab-aqvh; during period 3 (open label), all patients received adalimumab-aqvh. The primary endpoint was the proportion of patients with a 75% improvement in the Psoriasis Area and Severity Index (PASI-75) at week 12, and a post hoc efficacy endpoint was the mean percentage change in PASI at week 16. Secondary endpoints were PASI-75 over time, percentage change in PASI over time, Physician Static Global Assessment (PSGA) score of 0/1, and mean change in PSGA. Pharmacokinetics, immunogenicity, and safety were also assessed.

Results: Of the 545 patients randomly assigned, 77.0% of patients receiving adalimumab-aqvh and 74.9% of those receiving adalimumab achieved PASI-75; the 95% CI for treatment difference in PASI-75 was –4.75% to 9.21% at week 12. As this 95% CI was within the prespecified range (–15% to 15%), equivalence was established. The mean percent change in PASI at week 16 was –83.1% with adalimumab-aqvh and –82.3% with adalimumab; the 90% CI for treatment difference was –4.78% to 3.01%, which was also within the prespecified range (–10% to 10%). All other secondary endpoints, pharmacokinetics, immunogenicity, and safety were also similar between treatments.

Conclusion: There were no clinically meaningful differences in efficacy, safety, immunogenicity, or pharmacokinetics between adalimumab-aqvh and adalimumab in patients with psoriasis. All endpoints demonstrated similarity between adalimumab-aqvh and adalimumab.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-and-safety-similarity-of-biosimilar-adalimumab-aqvh-to-adalimumab-in-patients-with-moderate-to-severe-chronic-plaque-psoriasis-a-phase-iii-study/