Japanese patients with psoriasis reported improved objective symptoms and satisfaction with brodalumab.
Brodalumab was associated with significantly improved objective symptoms and satisfaction in Japanese patients with plaque psoriasis, according to study findings published in Journal of Dermatological Science.
Designed as a human anti–interleukin-17 receptor A immunoglobulin G2 monoclonal antibody, brodalumab is approved worldwide for the treatment of plaque psoriasis in patients who respond inadequately to other systemic therapies. However, researchers noted that real-life evidence on the quality of the biologic based on patient-reported outcomes in psoriasis remains limited.
“Differences in observations between randomized controlled trials (RCTs) and real-life settings have been reported, such as the absolute change in Psoriasis Area Severity Index (PASI) after biologic treatment and frequency of adverse events, and only approximately 60% of patients with psoriasis present with a severity that meets the eligibility criteria for RCTs in real-life settings,” they added. "It is therefore essential to accumulate evidence on the real-life effectiveness of biologic treatment for psoriasis using patient-reported outcomes such as Patient Global Assessment (PtGA) and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9)."
Researchers conducted the single-arm, open-label, multicenter, prospective ProLOGUE study to assess the effectiveness and safety of brodalumab in 73 Japanese patients with plaque psoriasis in a real-life setting.
In the study, outsomes were assesed among the participants (median age, 54.0 years; median PASI score, 12.1; 82.2% male; 39.7% had used prior biologics), all of whome were treated at 15 facilities in Japan between October 2017 and March 2020, for PASI scores, PtGA scores, body surface area (BSA), and TSQM-9 domain scores at baseline and weeks 12 and 48 of brodalumab treatment. A total of 56 patients completed treatment to week 48, indicating a drug survival rate of 76.7%.
“At baseline, week 12, and week 48, 73, 73, and 69 patients, respectively, had evaluable PASI and BSA data, and complete PRO data were available for 73, 72, and 65 patients, respectively," the authors noted.
Compared with baseline, significant reductions in PASI scores and BSA were observed at weeks 12 and 48 (both P < .0001). Moreover, a majority of patients felt that the treatment was effective at weeks 12 (90.3%) and 48 (90.8%) based on the PtGA score, with TSQM-9 domain scores shown to be significantly improved at weeks 12 and 48 as well (all P < .0001).
“The PtGA score at week 12 was significantly different between biologic-naive and biologic-experienced patients (P = .0497), while no statistically significant difference was observed between the groups in the PtGA score at week 48 and all TSQM-9 domain scores at weeks 12 and 48," wrote the authors.
Further findings from an area under the receiver operating characteristic curve (ROC) analysis suggested a PASI score of 2 or below as a treatment goal for biologic treatment of psoriasis. However, some of the TSQM-9 domain scores did not improve in patients achieving this goal.
No new safety signals were observed, no serious drug-related treatment-related adverse events were reported, and adverse events were limited to 5% or less of patients.
“Setting a PASI score of less than or equal to 2 as a real-life goal for biologic treatment of psoriasis may be feasible, although achieving this PASI goal alone may be insufficient to clearly improve patient satisfaction, especially in a long-term treatment,” concluded the study authors.
Imafuku S, Ohata C, Okubo Y, et al. Effectiveness of brodalumab in achieving treatment satisfaction for patients with plaque psoriasis: the ProLOGUE study. J Dermatol Sci. 2022 Feb 15;S0923-1811(22)00038-X. doi:10.1016/j.jdermsci.2022.02.007