Plaque Psoriasis Treatments: BMS-986165 Promising & Adalimumab Biosimilar Demonstrates Equivalence

During the 27th European Academy of Dermatology and Venerology (EADV) Congress in September, data was presented on the efficacy of BMS-986165, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for treating plaque psoriasis. Additionally, research was presented on the bioequivalence of Cyltezo (adalimumab-adbm) to adalimumab.

Phase 2 Study Results for BMS-986165
BMS-986165 is an oral, selective tyrosine kinase 2 (TYK2) inhibitor being investigated for treating patients with moderate to severe plaque psoriasis.¹ At EADV Congress, researchers presented data from the IM011-011 trial, a multi-center, randomized, double-blind, placebo-controlled, parallel group phase 2 study.

The trial evaluated the clinical efficacy and safety of BMS-986165 in patients (N=267) with moderate to severe psoriasis. Patients received 3 mg BMS-986165 (n=44) every other day, 3 mg BMS-986165 every day (n=44), 3 mg BMS-986165 twice daily (n=45), 6 mg BMS-986165 twice daily (n=45), 12 mg BMS-986165 every day (n=44) or placebo (n=45). The primary endpoint was Psoriasis Area and Severity Index (PASI) 75 at Week 12. Key secondary endpoints were attaining the PASI 90 and PASI 100, as well as Dermatology Life Quality Index (DLQI).

At Week 12, PASI 75 and PASI 90 were achieved in 67–75% of patients treated with 3 mg or more BMS-986165 compared with 7% of placebo-treated patients. Patients experienced treatment efficacy regardless of whether they had prior exposure to a biologic therapy. Data showed a favorable risk-benefit profile, with diarrhea, headache, nasopharyngitis, nausea and upper respiratory tract infections being the most common adverse events reported.

Adalimumab Biosimilar Demonstrates Clinical Equivalence
Also during the Congress, a phase 3 study presented confirmed that Cyltezo (adalimumab-adbm) is equivalent to Humira (adalimumab), its reference product. No clinically meaningful differences in efficacy, safety and immunogenicity in patients with moderate to severe chronic plaque psoriasis were demonstrated in this 16-week study.^2,3

This randomized, double-blind, parallel-arm, multiple-dose, active comparator trial was in patients (N=318) from 18 and 78 years old with moderate to severe chronic plaque psoriasis. The primary endpoint, which was met, was the proportion of patients achieving a 75% reduction in PASI at Week 16. Patients could not have been previously treated with one or more biologic agent. Patients were randomized to receive 80 mg Cyltezo or 80 mg Humira on Day 1. They then received 40 mg on Day 7 and 40 mg every other week thereafter.

In 2019, researchers expect 24-week data to be available.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Bristol-Myers Squibb. News release: Bristol-Myers Squibb’s novel, oral, selective TYK2 inhibitor delivered significant skin clearance in patients with moderate to severe plaque psoriasis in phase 2 trial. 2018 Sep 12.
2. Boehringer Ingelheim. News release: Biosimilar Cyltezo demonstrates clinical equivalence to Humira in patients with moderate to severe plaque psoriasis. 2018 Sep 12.
3. Boehringer Ingelheim. Efficacy, safety and immunogenicity of BI695501 vs. Humira in patients with moderate to severe chronic plaque psoriasis. ClinicalTrials.gov. 2018 May 23.