BACKGROUND: REVEAL was a 52-week phase III trial of adalimumab therapy for moderate to severe chronic plaque psoriasis. Patients from REVEAL could enter an open-label extension trial to receive adalimumab for approximately 3 years of total therapy. OBJECTIVE: We sought to determine long-term efficacy and safety of continuous adalimumab therapy for patients from REVEAL. METHODS:Efficacy and safety over greater than 3 years of treatment were analyzed for 4 groups of patients from REVEAL. Patients who received adalimumab continuously from baseline were grouped by their responses in REVEAL: (1) greater than or equal to 75% improvement in Psoriasis Area and Severity Index (PASI) score (PASI 75) at weeks 16 and 33 (sustained responders); (2) less than PASI 75 at week 16; and (3) greater than or equal to PASI 75 at week 16 with 50% to less than 75% improvement in PASI score at week 33. Results were also analyzed for patients who began adalimumab after 16 weeks of placebo therapy. RESULTS: For patients with sustained PASI 75 responses during REVEAL, efficacy was generally well maintained over 3 years, with 75%/90%/100% improvement in PASI score response rates (last observation carried forward) of 83%/59%/33% after 100 weeks and 76%/50%/31% after 160 weeks of continuous therapy. Some patients with less than PASI 75 responses in REVEAL also achieved long-term PASI 75 responses. Efficacy in the placebo/adalimumab group was consistent with the ensemble of results from the other 3 groups. Adverse event rates were consistent with those during REVEAL. LIMITATIONS: The REVEAL study design prevented analyzing all patients from the adalimumab arm as one long-term cohort. CONCLUSION:Adalimumab efficacy was well maintained over more than 3 years of continuous therapy for patients with sustained initial PASI 75 responses. Maintenance was best at the PASI 100 level.
RCT Entities:
BACKGROUND: REVEAL was a 52-week phase III trial of adalimumab therapy for moderate to severe chronic plaque psoriasis. Patients from REVEAL could enter an open-label extension trial to receive adalimumab for approximately 3 years of total therapy. OBJECTIVE: We sought to determine long-term efficacy and safety of continuous adalimumab therapy for patients from REVEAL. METHODS: Efficacy and safety over greater than 3 years of treatment were analyzed for 4 groups of patients from REVEAL. Patients who received adalimumab continuously from baseline were grouped by their responses in REVEAL: (1) greater than or equal to 75% improvement in Psoriasis Area and Severity Index (PASI) score (PASI 75) at weeks 16 and 33 (sustained responders); (2) less than PASI 75 at week 16; and (3) greater than or equal to PASI 75 at week 16 with 50% to less than 75% improvement in PASI score at week 33. Results were also analyzed for patients who began adalimumab after 16 weeks of placebo therapy. RESULTS: For patients with sustained PASI 75 responses during REVEAL, efficacy was generally well maintained over 3 years, with 75%/90%/100% improvement in PASI score response rates (last observation carried forward) of 83%/59%/33% after 100 weeks and 76%/50%/31% after 160 weeks of continuous therapy. Some patients with less than PASI 75 responses in REVEAL also achieved long-term PASI 75 responses. Efficacy in the placebo/adalimumab group was consistent with the ensemble of results from the other 3 groups. Adverse event rates were consistent with those during REVEAL. LIMITATIONS: The REVEAL study design prevented analyzing all patients from the adalimumab arm as one long-term cohort. CONCLUSION:Adalimumab efficacy was well maintained over more than 3 years of continuous therapy for patients with sustained initial PASI 75 responses. Maintenance was best at the PASI 100 level.
Authors: Nouf Alballa; Alanoud Alyousef; Albatool Alamari; Ahmed Abdullah Alhumidi; Mohammed Ayesh Zayed; Leena Zeitouni; Fahad Mohammed Alsaif Journal: AME Case Rep Date: 2018-12-24
Authors: Antonio Costanzo; Filomena Russo; Marco Galluzzo; Luca Stingeni; Roberta Scuderi; Leonardo Zichichi; Manuela Papini; Luisa Di Costanzo; Andrea Conti; Martina Burlando; Andrea Chiricozzi; Francesca Maria Gaiani; Cristina Mugheddu; Maria Letizia Musumeci; Paolo Gisondi; Stefano Piaserico; Paolo Dapavo; Marina Venturini; Gianluca Pagnanelli; Paolo Amerio; Concetta Potenza; Ketty Peris; Franca Cantoresi; Sara Trevisini; Francesco Loconsole; Annamaria Offidani; Santo Raffaele Mercuri; Viviana Lora; Francesca Prignano; Marta Bartezaghi; Giovanni Oliva; Elisabetta Aloisi; Roberto Orsenigo Journal: Acta Derm Venereol Date: 2021-10-21 Impact factor: 3.875
Authors: A Blauvelt; C Paul; P van de Kerkhof; R B Warren; A B Gottlieb; R G Langley; F Brock; C Arendt; M Boehnlein; M Lebwohl; K Reich Journal: Br J Dermatol Date: 2020-09-06 Impact factor: 9.302