Background/Purpose: BI 695501 is a FDA-approved biosimilar to adalimumab RP (AbbVie), and is approved in seven indications, including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis. The objectives of our study were to assess pharmacokinetic similarity, as well as efficacy, immunogenicity, and safety in patients with moderate-to-severe chronic plaque psoriasis receiving adalimumab RP continuously versus those who switched several times between BI 695501 and adalimumab RP.

Methods: Patients with moderate-to-severe chronic plaque psoriasis received adalimumab RP (80 mg Day 1; 40 mg/0.8 mL every other week [EOW] from Weeks 2–12) and were then randomized to ‘switching’ (BI 695501 40 mg/0.8 mL Weeks 14 and 16; adalimumab RP Weeks 18 and 20; BI 695501 EOW Weeks 22–48) or ‘continuous’ (adalimumab RP EOW Weeks 14–48) treatment. Primary endpoints were C_max,30–32 and AUC_τ,30–32 (bioequivalence acceptance limits: 80–125%). Secondary endpoints included: PASI75 response, anti-drug antibodies (ADA) and neutralizing ADAs (nAb) at Week 32, and drug-related treatment-emergent adverse events (TEAEs) post-randomization (NCT03210259).

Results: Baseline characteristics were generally balanced between groups (switching, n=118; continuous, n=120). In the analyzable switching (n=104) and continuous groups (n=99), adjusted mean C_max,30–32 was 7.08 and 7.00 μg/mL, respectively (point estimate for the ratio: 101.14%; 90.2% CI: 93.26, 109.70); adjusted mean AUC_τ,30–32 was 2025.83 and 1925.90 μg·h/mL, respectively (105.19%; 90.2% CI: 96.58, 114.64). At Week 32, in the analyzable switching and continuous groups, respectively: 100/118 (85%) and 94/119 (79%) patients had PASI75 response (difference: 5.75%; 90% CI: -2.45, 13.96); 101/112 (90%) and 104/110 (95%) patients were ADA positive; 46/112 (41%) and 46/110 (42%) patients were nAb positive. Post-randomization, 67/118 (57%; switching) and 75/120 (63%; continuous) patients had ≥1 drug-related TEAE.

Conclusion: These data support BI 695501’s designation as an interchangeable biosimilar to adalimumab RP, based on similar outcomes between the switching and continuous treatment groups, in terms of pharmacokinetics efficacy, immunogenicity and safety. The results of this study are highly applicable to patients with rheumatoid disease, for which BI 695501 is approved.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/phase-iii-randomized-trial-comparing-clinical-outcomes-between-patients-with-moderate-to-severe-chronic-plaque-psoriasis-receiving-adalimumab-reference-product-rp-continuously-versus-those-who-swit/