Piergiacomo Calzavara-Pinton

Brodalumab is effective in improving skin lesions and life quality of biologic-naïve and biologic-experienced individuals with moderate-to-severe psoriasis, according to new findings.¹

These findings were the results of a retrospective study of brodalumab’s effects on psoriasis patients, especially after the AMAGINE-2 trial’s results which indicated the drug had maintained clearance of skin through 120 weeks.²

The research was authored by Piergiacomo Calzavara-Pinton, a Professor of Dermatology and the Chairman of the Department of Dermatology and Postgraduate School of Dermatology at the University and Spedali Civili of Brescia, Italy.

“This study was aimed at evaluating the achievement and maintenance of a therapeutic response over 1 year in patients with moderate-to-severe plaque psoriasis treated with brodalumab in the Italian current clinical practice,” Calzavara-Pinton and colleagues wrote.

Background and Findings

The investigators conducted the trial, known as the BRIGHT study, as a non-interventional, multicenter cohort study conducted across 20 Italian hospital dermatology clinics. The team used both primary and secondary data collection, with a retrospective observation period of 12 (±4) weeks from brodalumab’s initiation up to the enrollment visit.

Consecutive patients aged ≥18 years with moderate-severe plaque psoriasis were included, along with those who had discontinued brodalumab before enrollment. The study aimed to achieve an absolute PASI score ≤3 at Week 12 and maintain it through Week 52 (±4).

The investigators’ other objectives included assessing the effectiveness, patients' characteristics, and adverse events as well as comparing therapeutic responses, and examining clinician assessments and patient-reported outcomes. The research team also defined the sample size based on feasibility, with no specific statistical hypotheses being pre-determined.

Descriptive analyses were conducted by the investigators through various statistical measures. The Full-Analysis-Set (FAS) population included eligible study participants with at least a single assessment score following brodalumab’s initiation.

Adverse events were analyzed based on the safety population, which included all of those who had been given brodalumab treatment. Overall, the primary goal was to describe the efficacy of brodalumab using achievement and maintenance of a PASI score of ≤3 at 12 weeks and up to 52 weeks.

In the study, 184 eligible patients were included, with 164 finishing the observation period of approximately 11.9 months. By the time of enrollment, the average disease duration was found by the investigators to be 13.9 years, and 94% of patients showed clinical manifestations of psoriasis, primarily erythema, and itching.

Almost all patients (95.6%) had received previous antipsoriatic treatments before starting brodalumab. Of those, 64.7% achieved a Psoriasis Area and Severity Index (PASI) score of ≤3 by 12 weeks and maintained it throughout the 52-week time period.

At 12 weeks, the investigators noted that PASI 75, PASI 90, and PASI 100 responses were achieved by 72.7%, 54.5%, and 42.0% of study participants, respectively. By 52 weeks in, PASI 75, PASI 90, and PASI 100 responses were observed in 92.9%, 84.4%, and 61.7% of them, respectively.

The research team also found that a static Physician's Global Assessment (sPGA) score of 0 was reported by 55.0% at 12 weeks and 77.0% at 52. Additionally, they noted that 71.9% of them reported a Dermatology Life Quality Index (DLQI) score of ≤1 after 12 weeks, increasing to 89.9% after 52.

The investigators found no substantial differences in outcomes among the subgroups based on previous antipsoriatic treatments.

“Brodalumab was equally effective in both biologic-naïve and biologic-experienced patients,” they wrote. “The safety profile of brodalumab in the routine clinical practice was largely reassuring, confirming the favourable benefit-risk balance of brodalumab emerged from previous randomised clinical trials.”

References

1. ^{Dapavo, P, Fabbrocini, G, Campione, E, Giofrè, C, Balato, A, Potenza, C, et al. Achievement and maintenance of therapeutic response to brodalumab in patients with moderate-to-severe plaque psoriasis: an Italian, observational, retrospective and prospective study (BRIGHT study). JEADV Clin Pract. 2023; 1– 14. https://doi.org/10.1002/jvc2.204.}
2. ^{Puig L, Lebwohl M, Bachelez H, Sobell J, Jacobson AA. Long-term efficacy and safety of brodalumab in the treatment of psoriasis: 120-week results from the randomized, double-blind, placebo- and active comparator–controlled phase 3 AMAGINE-2 trial. J Am Acad Dermatol. 2020; 82(2): 352– 359.}