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In terms of safety, clinical
efficacy, and immunogenicity, HLX03 was found to be equivalent to adalimumab in
psoriasis patients.
In people with moderate-to-severe plaque psoriasis, HLX03 (biosimilar of adalimumab) showed equivalent efficacy, safety and immunogenicity profiles when compared to adalimumab, thus favoring its development as a substitute therapy for psoriasis management. Lin Cai et al. undertook this parallel-group, double-blind, active-controlled, phase III study to compare the immunogenicity, safety, and efficacy of HLX03 with reference adalimumab in 262 adults with psoriasis.
With the aim to determine clinical equivalence between HLX03 and adalimumab, participants (aged 18–75 years) were randomly allocated to receive HLX03 or adalimumab (80 mg at week one, 40 mg at week two, and then 40 mg every two weeks) for forty-eight weeks. There were 132 participants in the HLX03 group and 130 participants in the adalimumab group.
An improvement in the Psoriasis Area and Severity Index (PASI) score noted at week 16 vs. baseline was the major outcome ascertained. Other efficacy outcomes, immunogenicity, and safety were also determined. The PASI improvements at week 16 in the study groups (least-square-mean difference was 1.5%) reported in the full analysis set is shown in Table 1:
In terms of percentage of people attaining ≥ 75% improvement from baseline PASI (PASI 75), alteration in dermatology life quality index (DLQI) score, and physician global assessment 0/1 (clear or almost clear), no profound differences were noted between the study groups.
Occurrence of noxious events and the percentage of people with antidrug
antibodies were also similar between HLX03 and adalimumab groups. Thus, HLX03
offers an alternative therapy choice for individuals having psoriasis.
Advances in Therapy
Efficacy and Safety of HLX03, an Adalimumab Biosimilar, in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blind, Phase III Study
Lin Cai et al.
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