Clinical Similarity of the Biosimilar ABP 501 Compared With Adalimumab After Single Transition: Long-Term Results From a Randomised, Double-Blind, 52-Week, Phase 3 Study in Moderate-to-Severe Plaque Psoriasis Patients

Abstract

Background

ABP 501, an FDA- and EMA-approved biosimilar, is highly similar to adalimumab in structure, function, and pharmacokinetics.

Objective

Demonstrate similarity in efficacy, safety, and immunogenicity of ABP 501 versus adalimumab for moderate-to-severe plaque psoriasis.

Methods

Patients were randomised (1:1) to receive ABP 501 or adalimumab 40 mg every 2 weeks for 16 weeks. At Week 16, patients with ≥50% improvement from baseline in psoriasis area-and-severity index score (PASI) were eligible to continue to Week 52. Patients receiving ABP 501 continued; adalimumab patients were re-randomised (1:1) to continue adalimumab or undergo a single transition to ABP 501. Key efficacy assessments included % PASI improvement from baseline, PASI responders, and mean change in affected body surface area (BSA) from baseline to Weeks 16, 32, and 50. Safety was monitored via adverse events (AEs) and antidrug antibodies (ADAs) were assessed.

Results

308 patients were re-randomised at Week 16 (ABP 501/ABP 501, n=152; adalimumab/adalimumab, n=79; adalimumab/ABP 501, n=77). PASI percent improvements from baseline were similar across groups for Weeks 16, 32, and 50 (range: 85.8%-88.2%), with no significant differences detected across groups in percentages of PASI 50, 75, 90, and 100 responders. Changes from baseline in %BSA affected were similar across groups and timepoints. No new safety signals were detected. AEs were balanced between groups. Percentages of patients with binding and neutralizing ADAs were similar across treatments.

Conclusions

ABP 501 and adalimumab have similar clinical efficacy, safety, and immunogenicity profiles over 52 weeks, including after single transition, in this patient population.

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