Complete clearance and psoriasis area and severity index response for brodalumab and ustekinumab in AMAGINE-2 and -3
Warren, Richard B. (Dermatology Centre. The University of Manchester. Salford Royal NHS Foundation Trust. NIHR Manchester BRC Centre)
Hansen, Jes Birger (LEO Pharma)
Reich, Kristian (Universitätsklinikum Hamburg-Eppendorf (UKE))
Paul, Carle (Toulouse University and Larrey Hospital)
Puig Sanz, Lluís (Institut d'Investigació Biomèdica Sant Pau)
Universitat Autònoma de Barcelona

Data:	2021
Resum:	Background: Modern biologics achieve complete skin clearance [100% improvement in psoriasis area and severity index (PASI 100)] in 30-45% of psoriasis patients. Cumulative benefit considering rapidity, frequency and sustainability of response has not been thoroughly investigated. Objectives: Compare the frequency, rapidity and sustainability of PASI 90 and 100 response in patients with moderate-to-severe psoriasis treated with brodalumab or ustekinumab. Methods: Integrated analyses of the brodalumab Phase III AMAGINE-2 (NCT01708603) and -3 (NCT01708629) trials were performed to determine proportion of patients achieving PASI response per visit; corresponding odds ratios (OR) were calculated. Cumulative clinical benefit of treatment was determined with area-under-the-curve (AUC) analysis. Cumulative incidence of response was analysed using a competing risk model of PASI response or rescue. Sustained response was evaluated by time to inadequate response using Kaplan-Meier methods. Proportion of time spent in different response states was descriptively analysed. Association between PASI response and health-related quality of life [Dermatology Life Quality Index (DLQI)] was assessed using data from all treatment groups from AMAGINE-1, -2 and -3. Results: A significantly higher proportion of patients treated with brodalumab achieved PASI 100 vs. ustekinumab (Week 52: 51% vs. 28%; OR [95% CI] 2. 8 [2. 1, 3. 7]; P < 0. 0001), with significant differences observed from Week 4. Cumulative benefit through 52 weeks was 69% higher with brodalumab (AUC ratio: 1. 69; P < 0. 001). Brodalumab patients were also significantly more likely to achieve a PASI 100 at least once over 52 weeks vs. ustekinumab (76% vs. 52%; P < 0. 0001). Once response was achieved, brodalumab patients had a low likelihood of failure or need for rescue. There was significant positive association between PASI response level and DLQI0/1 achievement (P < 0. 0001). Conclusion: Brodalumab treatment resulted in significantly higher levels of skin clearance, longer sustained response and greater cumulative treatment benefit vs. ustekinumab.
Nota:	Altres ajuts: The AMAGINE-1, AMAGINE-2 and AMAGINE- 3 trials were sponsored by Amgen and AstraZeneca; this analysis was performed by LEO Pharma. Medical writing support was provided by Ian Eustace from Adelphi Communications Ltd, Bollington, UK, funded by LEO Pharma.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Antibodies, Monoclonal, Humanized ; Dermatologic Agents ; Humans ; Psoriasis ; Quality of Life ; Severity of Illness Index ; Treatment Outcome ; Ustekinumab
Publicat a:	Journal of the European Academy of Dermatology and Venereology, Vol. 35 Núm. 2 (february 2021) , p. 450-457, ISSN 1468-3083

DOI: 10.1111/jdv.16816
PMID: 32662540

8 p, 294.7 KB

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