Dataset Information

Brodalumab for the Treatment of Psoriasis: A Review of Phase III Trials.

ABSTRACT:

Introduction

Interleukin (IL)-17 inhibitors are the most recent class of monoclonal antibodies approved by the FDA for psoriasis treatment. Preclinical and phase II studies of brodalumab, a high-affinity IL-17 receptor monoclonal antibody, have been encouraging.

Methods

We conducted a literature search using the PubMed database in order to assess the efficacy and safety profile of brodalumab. The search included the following key words: "psoriasis" and "IL-17" or "brodalumab." We also reviewed citations within articles to identify relevant sources.

Results

At week 12, the proportion of patients attaining a 75% improvement from the baseline Psoriasis Area and Severity Index (PASI 75) was similar among the three phase III trials (AMAGINE-1, 83%; AMAGINE-2, 86%; AMAGINE-3, 85%). Brodalumab remained efficacious through 52 weeks of treatment. It maintained a satisfactory safety profile; the most frequently reported adverse events consisted of nasopharyngitis, headache, upper respiratory tract infection, and arthralgia.

Conclusion

Use of brodalumab revealed prompt clinical improvement and a favorable short-term safety profile in phase III trials, although further extension studies are needed to assess long-term safety. Based on the results, brodalumab appears to be a potent therapeutic option for patients with moderate-to-severe plaque-type psoriasis.

SUBMITTER: Farahnik B

PROVIDER: S-EPMC4906115 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceGiven the possible treatment modalities in psoriasis management, little is known about whether drug monitoring is associated with response rate.ObjectiveTo determine whether drug monitoring is associated with response to brodalumab therapy.DesignA multicenter case series study of patients with psoriasis treated with brodalumab whose treatment with previous IL-17A inhibitor therapy failed. Patients were recruited from the Departments of Dermatology at Gentofte and Aarhus University Hospitals, Denmark, between 2018 and 2020. Patient visits were conducted after 4 and 12 weeks of therapy. Patients not achieving Psoriasis Area and Severity Index 75% improvement from baseline (PASI 75) after 12 weeks were discontinued and considered nonresponders. Patients maintaining PASI 75 response were followed up for up to 52 weeks.ExposureTreatment with brodalumab, 210 mg, at weeks 0, 1, 2, then every 2 weeks.Main outcomes and measuresOutcome measures were PASI reductions vs brodalumab levels and antibrodalumab antibodies.ResultsTwenty patients with psoriasis (13 [65%] were male; median age, 50 years [range, 19-66 years]) were included. After 12 weeks of therapy, patients with quantifiable levels of brodalumab (≥0.05 μg/mL) experienced significantly higher PASI reductions than those without (median, 93%; range, 61%-100% vs median, -3; range, -49% to 94%, respectively; P = .006). After 12 weeks of therapy, 4 of 5 patients (80%) not achieving PASI 75 had subquantifiable drug levels (<0.05 μg/mL), although this finding was seen for only 3 of 14 PASI 75 responders (21%). None of 7 patients (35%) with subquantifiable drug levels after 12 weeks of therapy maintained response. No antibrodalumab antibodies were detected in any of the tested samples.Conclusions and relevanceResults of this case series study suggest that circulating brodalumab level is a factor associated with clinical treatment response. Monitoring patient levels of circulating brodalumab may aid clinical decision-making and help prevent ineffective therapy.