Efficacy and safety of itolizumab, a novel anti-CD6 monoclonal antibody, in patients with moderate to severe chronic plaque psoriasis: results of a double-blind, randomized, placebo-controlled, phase-III study.

Autor: Krupashankar DS; Manipal Hospital, Bangalore, India., Dogra S; Postgraduate Institute of Medical Education and Research, Chandigarh, India., Kura M; Grant Medical College and JJ Group of Hospitals, Mumbai, India., Saraswat A; Indushree Skin Clinic, Lucknow, India., Budamakuntla L; Bowring and Lady Curzon Hospitals, Bangalore, India., Sumathy TK; M S Ramaiah Memorial Hospital, Bangalore, India., Shah R; Apollo Hospital, Hyderabad, India., Gopal MG; Kempegowda Institute of Medical Sciences, Bangalore, India., Narayana Rao T; King George Hospital, Visakhapatnam, India., Srinivas CR; PSG Hospitals, Coimbatore, India., Bhat R; Father Muller Medical College and Hospital, Mangalore, India., Shetty N; AJ Institute of Medical Sciences, Mangalore, India., Manmohan G; Derma Skin Clinic, Hyderabad, India., Sai Krishna K; Sri Sai Skin Clinic, Hyderabad, India., Padmaja D; Sumana Hospital, Hyderabad, India., Pratap DV; Durgabhai Deshmukh Hospital, Hyderabad, India., Garg V; Maulana Azad College and Lok Nayak Hospital, New Delhi, India., Gupta S; Skin and Laser Center, Delhi, India., Pandey N; DermaKlinic Skin, Laser and Cosmetic Clinic, Lucknow, India., Khopkar U; Seth G.S. Medical College and KEM Hospital, Mumbai, India., Montero E; Center of Molecular Immunology, Havana, Cuba; Biocon Research Limited, Bangalore, India., Ramakrishnan MS; Biocon Research Limited, Bangalore, India., Nair P; Biocon Research Limited, Bangalore, India., Ganapathi PC; Biocon Research Limited, Bangalore, India. Electronic address: drprasannacg@gmail.com.
Jazyk: angličtina
Zdroj: Journal of the American Academy of Dermatology [J Am Acad Dermatol] 2014 Sep; Vol. 71 (3), pp. 484-92. Date of Electronic Publication: 2014 Apr 02.
DOI: 10.1016/j.jaad.2014.01.897
Abstrakt: Background: Itolizumab, a humanized monoclonal antibody to CD6, is a novel therapeutic agent evaluated in chronic plaque psoriasis.
Objective: We sought to assess the safety and efficacy of itolizumab in moderate to severe chronic plaque psoriasis.
Methods: A total of 225 patients were randomized (2:2:1) to 2 different itolizumab arms (A or B; A = 4-week loading dose of 0.4 mg/kg/wk followed by 1.6 mg/kg every 2 weeks; B = 1.6/mg every 2 weeks) or placebo. At week 12, the placebo arm was switched to 1.6 mg/kg itolizumab every 2 weeks. The primary end point was the proportion of patients with at least 75% improvement in Psoriasis Area and Severity Index score at week 12.
Results: At week 12, 27.0% in arm A (P = .0172 vs placebo), 36.4% in B (P = .0043 vs placebo), and 2.3% in the placebo arm had at least 75% improvement in Psoriasis Area and Severity Index score. At week 28, the proportion with at least 75% improvement in Psoriasis Area and Severity Index score was comparable: 46.1%, 45.5%, and 41.9% for A, B, and placebo, respectively. In weeks 1 to 12, the incidence of all adverse events was comparable across arms (A, 43%; B, 38%; placebo, 47%) and the incidence of infections was not greater than placebo (11.1%, 8.9%, and 18.6% for A, B, and placebo).
Limitations: No active comparator is a limitation.
Conclusions: Itolizumab is an effective and well-tolerated novel biological therapy in moderate to severe psoriasis.
(Copyright © 2014 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.)
Databáze: MEDLINE
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