Improvement in itch and other psoriasis symptoms with brodalumab in phase 3 randomized controlled trials
Autor: | Radhakrishnan Pillai, Robert J. Israel, Sylvia Hsu, Kenneth B. Gordon, Leon H Kircik, Boni E. Elewski, Lawrence F. Eichenfield, Shipra Rastogi, Alice B. Gottlieb |
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Rok vydání: | 2018 |
Předmět: |
Adult
Male medicine.medical_specialty Brodalumab Pain Dermatology Antibodies Monoclonal Humanized Placebo Severity of Illness Index law.invention 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Double-Blind Method Quality of life Randomized controlled trial law Internal medicine Psoriasis Severity of illness Ustekinumab medicine Humans Patient Reported Outcome Measures business.industry Pruritus Antibodies Monoclonal Middle Aged medicine.disease Clinical trial Infectious Diseases Erythema 030220 oncology & carcinogenesis Female Dermatologic Agents Symptom Assessment business medicine.drug |
Zdroj: | Journal of the European Academy of Dermatology and Venereology. 32:1305-1313 |
ISSN: | 0926-9959 |
Popis: | BACKGROUND Patients with psoriasis have lesional symptoms, including itch, which can reduce quality of life. The efficacy and safety of brodalumab, an interleukin-17 receptor A antagonist, in treating moderate-to-severe psoriasis have been reported in three randomized, controlled, phase 3 trials (AMAGINE-1/-2/-3). OBJECTIVE The effect of brodalumab on lesional symptoms was assessed using the psoriasis symptom inventory (PSI), a validated patient-reported instrument. METHODS Patients were randomized to receive brodalumab (140 or 210 mg every 2 weeks [Q2W]), placebo (AMAGINE-1/-2/-3), or ustekinumab (AMAGINE-2/-3) during a 12-week induction phase, followed by a maintenance phase through week 52. Patients electronically rated the severity of PSI items (itch, burning, stinging, pain, redness, scaling, cracking and flaking) during the previous 24 h on a scale of 0 (not at all severe) to 4 (very severe). At each visit, the PSI total score responder status was assessed, with responders defined as having an average weekly total inventory score ≤8 with no item score >1 at week 12. RESULTS Across AMAGINE-1/-2/-3, brodalumab was associated with improvements in PSI total scores and itch scores vs. placebo from week 2 through week 12 (P |
Databáze: | OpenAIRE |
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