Objective symptoms of psoriasis and patient satisfaction were improved with brodalumab treatment. These findings, from a single-arm, open-label, multicenter, prospective study, were published in the Journal of Dermatological Science.
The ProLOGUE study was conducted from 2017 to 2020 at 15 centers in Japan. Patients (N=73) with plaque psoriasis received 210 mg subcutaneous brodalumab on day 1, week 1, and week 2, followed by every 2 weeks up to week 48. Patients were assessed by Psoriasis Area and Severity Index (PASI), body surface area (BSA), Patient Global Assessment (PtGA), and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) instruments.
The patient cohort was 82.2% men, aged median 54.0 (interquartile range [IQR], 44.0-64.0) years, PASI score was 12.1 (IQR, 8.8-16.0), and 39.7% had a history of using biologic agents.
At week 12, 72.2% had improved symptoms, 18.1% were in remission, 5.6% had no change, and 4.2% had worsened. At week 48, 61.5% had improved, 29.2% were in remission, 6.2% had no change, and 3.1% had worsened.
At weeks 12 and 48, PASI and BSA scores were significantly improved from baseline (all P <.0001).
No meaningful trends were observed on the basis of concomitant medications or previous exposure to biologic agents.
At week 48, 90.8% of patients reported the treatment was effective and all TSQM-9 domain scores improved from baseline (all P <.0001).
Using PtGA responses as an objective variable, a cutoff PASI score of 2.4 was found to have an area under the curve of 0.8093, sensitivity of 0.9322, and specificity of 0.3333. This indicates a PASI decrease of 2 or less may be a feasible goal from brodalumab therapy.
Stratified by low (£2; n=54) and high (>2; n=18) PASI scores, group differences were observed for TSQM-9 effectiveness (P =.0011) and global satisfaction (P =.0047) at week 12 and convenience (P =.0212) at week 48.
The overall drug survival rate was 76.7%. A total of 45.3% patients reported treatment-emergent adverse events. In all, 4 serious events of acute myocardial infarction, hemopericardium, secondary glaucoma, foot fracture were reported.
Although no differences were observed between patients who were taking concomitant medications, this comparison was limited by a lack of data about adherence and timing of use.
The researchers suggest that their study research found that brodalumab improved both objective symptoms and satisfaction among patients with plaque psoriasis, warranting further investigation.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
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;S0923-1811(22)00038-X. doi:10.1016/j.jdermsci.2022.02.007