A new study has demonstrated that ABP 654, a biosimilar to the reference drug ustekinumab, is equally effective and safe for patients with moderate to severe plaque psoriasis. The findings, published in the British Journal of Dermatology, show no significant clinical differences between ABP 654 and ustekinumab, even when patients transitioned from the reference product to the biosimilar.
ABP 654, which shares the same amino acid sequence as ustekinumab, was evaluated in a 52-week clinical trial to compare its efficacy, immunogenicity, and safety with ustekinumab. The trial included 563 patients across North America and Europe, aged 18 to 75 years, who had stable moderate to severe plaque psoriasis for at least six months. The primary endpoint was the Psoriasis Area and Severity Index (PASI) improvement at week 12.
Study Design and Methodology
The active-controlled, randomized, double-blind study (ClinicalTrials.gov Identifier: NCT04607980) randomly assigned participants to receive either ABP 654 or ustekinumab in a 1:1 ratio. Patients were given a subcutaneous dose of either 45 mg or 90 mg on day 1 (week 0), week 4, and week 16. Those who showed at least 75% improvement in PASI scores by week 28 were reassigned to either continue on ustekinumab or switch to ABP 654.
The study also excluded patients with erythrodermic psoriasis, pustular psoriasis, or induced psoriasis, as well as those previously treated with agents targeting interleukin (IL)-23 or IL-12.
Efficacy Results
At week 12, both treatment groups showed comparable improvements in PASI scores, with a mean percent improvement of 81.9% for both ABP 654 and ustekinumab groups. The study’s prespecified confidence interval for the PASI improvement margin was between -10% and +10%, and the observed difference between the groups was within this margin, confirming clinical similarity.
Secondary efficacy analyses further supported the conclusion that ABP 654 and ustekinumab performed similarly in terms of immunogenicity and safety. Additionally, there were no clinically significant differences in the incidence of serious adverse events (SAEs) between the two groups.
Safety and Adverse Events
Throughout the 52-week period, the incidence of serious adverse events was slightly lower in the ABP 654 group (2.8%) compared to the ustekinumab group (4.3%). Notably, the SAEs in both groups were generally unrelated to the treatments themselves. The ABP 654 group experienced a range of SAEs, including ovarian cancer, uterine leiomyoma, and cholelithiasis, while the ustekinumab group had incidents of acute myocardial infarction, postoperative infections, and COVID-19-related complications.
The researchers also found similar rates of cardiovascular events, infections, and malignancies between the two groups, further supporting the safety profile of ABP 654.
Conclusion and Implications
The study concluded that ABP 654 is clinically equivalent to ustekinumab in terms of efficacy, safety, and immunogenicity for the treatment of moderate to severe plaque psoriasis. Moreover, transitioning from ustekinumab to ABP 654 at week 28 did not affect the outcomes for the remainder of the study, reinforcing the biosimilar’s potential as a viable alternative to the reference drug.
Despite the promising results, the study noted that differences in the expression systems used for ABP 654 and ustekinumab could potentially influence the detection of antidrug antibodies (ADAs), which may impact efficacy or safety.
These findings suggest that ABP 654 could offer an effective treatment option for patients with plaque psoriasis, with no clinically meaningful differences from ustekinumab.
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