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: | Vijay Garg, M. S. Ramakrishnan, Pradip Nair, Enrique Montero, G. Manmohan, Mahendra M Kura, Abir Saraswat, Dasiga Venkata Subrahmanya Pratap, Prasanna C. Ganapathi, Sunil Dogra, Neeraj Pandey, Narendra J Shetty, C.R. Srinivas, T.K. Sumathy, Ramesh M Bhat, Kotla Sai Krishna, Radha Shah, M.G. Gopal, Dalavoi Padmaja, Uday Khopkar, D.S. Krupashankar, Leelavathy Budamakuntla, T Narayana Rao, Sandesh Gupta |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Itolizumab Dermatology Placebo Antibodies Monoclonal Humanized Gastroenterology Loading dose Severity of Illness Index Young Adult Double-Blind Method Psoriasis Area and Severity Index Internal medicine Psoriasis medicine Clinical endpoint Humans Adverse effect Aged business.industry Incidence (epidemiology) Middle Aged medicine.disease Surgery Intention to Treat Analysis Treatment Outcome Chronic Disease Female business medicine.drug |
| Zdroj: | Journal of the American Academy of Dermatology. 71(3) |
| ISSN: | 1097-6787 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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