Complete clearance and psoriasis area and severity index response for brodalumab and ustekinumab in AMAGINE-2 and -3
Warren, R. B. (Dermatology Centre. The University of Manchester. Salford Royal NHS Foundation Trust. NIHR Manchester BRC Centre)
Hansen, Jes Birger (LEO Pharma)
Reich, Kristian (Institute for Health Services Research in Dermatology and Nursing. University Medical Center Hamburg-Eppendorf. Skinflammation® Center)
Paul, C. (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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