Study Confirms Safety and Efficacy of BI's Humira Biosimilar

A phase 3b clinical trial assessing Boehringer Ingelheim’s (BI) adalimumab biosimilar (Cyltezo) demonstrated that the safety, efficacy, and immunogenicity of the drug were comparable to that of the reference product (Humira, AbbVie).

The results of the study were published as part of the American Academy of Dermatology Virtual Meeting Experience 2020 that was held from June 12-14.

The study included 318 adult patients with moderate-to-severe chronic plaque psoriasis for 6 months or more and had received no more than 1 previous biologic agent and were treatment-naïve to adalimumab.

Findings from Study

Patients were randomized 1:1 to receive 40 mg subcutaneously every other week of either Cyltezo or reference adalimumab over a 24-week treatment period. A total of 286 patients with a 50% reduction in Psoriasis Area and Severity Index (PASI) at week 16 continued on the trial.

Investigators said 141 patients in the biosimilar cohort and 134 from the reference adalimumab cohort completed the entire 24-week treatment period.

PASI 75% response rates at week 24 showed a significant similarity between the 2 treatment groups, demonstrating a difference of 2.9% between the groups, which investigators said was “well within the predefined equivalence margins.” PASI 50%, 90% and 100% response rates between the groups were also similar.

The mean improvement in PASI at week 24 was 84.6% (95% CI, 80.7-88.6) for Cyltezo and 85.4% (95% CI, 81.5-89.4) for reference adalimumab.

The incidence for adverse events (AEs) was similar between both groups, with 66 patients (41.5%) in the biosimilar group and 71 (44.9%) in the reference product group experiencing 1 or more AEs.

Serious AEs reported in the Cyltezo group consisted of abdominal abscess, oral herpes, upper respiratory tract infection, congestive cardiomyopathy, and psoriasis. Those reported for the reference adalimumab group included furuncle, kidney infection, orchitis, transient ischemic attack, pericarditis, chronic pancreatitis, toxic hepatitis, exostosis, foot deformity, and renal colic.

A similar proportion of patients in each group developed anti-drug antibodies and neutralizing antibodies by week 24, suggesting a comparable immunogenicity profile between the biosimilar and reference product. The PASI 75% response rate was lower among patients who were positive for drug antibodies than those who were not.

In 2018, researchers shared the results from another phase 3b study (VOLTAIRE-RAext) that demonstrated similar immunogenicity profiles of 2 adalimumab products.

More on Cyltezo

Cyltezo was approved for marketing in the United States in 2017 but is unable to come to market until at least 2023 due to Humira’s patent protections. It is 1 of 6 approved adalimumab biosimilars in the United States.

In 2017, BI initiated the VOLTAIRE-X trial to evaluate interchangeability of Cyltezo with reference adalimumab. In the United States, interchangeability at the pharmacy level is considered a separate designation from FDA marketing approval that requires additional clinical trials to obtain.

The drug was approved by the European Medicines Agency in 2017 but was withdrawn in 2019 when BI decided to focus solely on launching its biosimilar product in the United States and forgo European launches.