Faculty Collaboration Database

Improvement in itch and other psoriasis symptoms with brodalumab in phase 3 randomized controlled trials. J Eur Acad Dermatol Venereol 2018 Aug;32(8):1305-1313

Date

03/08/2018

Pubmed ID

29512200

DOI

10.1111/jdv.14913

Scopus ID

2-s2.0-85044522022 (requires institutional sign-in at Scopus site)   28 Citations

Abstract

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 < 0.001 in both domains). In AMAGINE-2/-3, brodalumab 210 mg Q2W demonstrated faster onset of PSI total score and itch responses (week 2, 22.1% and 36.4%, respectively) vs. ustekinumab (week 2, 6.9% and 17.1%, respectively) and was associated with improved itch responses vs. ustekinumab after 52 weeks of constant treatment.

CONCLUSION: Brodalumab demonstrated rapid, robust improvements in symptoms assessed by the PSI, including itch, vs. placebo and ustekinumab.

Author List

Gottlieb AB, Gordon K, Hsu S, Elewski B, Eichenfield LF, Kircik L, Rastogi S, Pillai R, Israel R

Author

Kenneth Brian Gordon MD Chair, Professor in the Dermatology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Dermatologic Agents
Double-Blind Method
Erythema
Female
Humans
Male
Middle Aged
Pain
Patient Reported Outcome Measures
Pruritus
Psoriasis
Severity of Illness Index
Symptom Assessment
Ustekinumab