Itolizumab, a humanized monoclonal antibody to CD6, is a novel therapeutic agent evaluated in chronic plaque psoriasis.
We sought to assess the safety and efficacy of itolizumab in moderate to severe chronic plaque psoriasis.
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.
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).
No active comparator is a limitation.
Itolizumab is an effective and well-tolerated novel biological therapy in moderate to severe psoriasis.Le texte complet de cet article est disponible en PDF.
Key words : anti-CD6, autoimmune disease, itolizumab, monoclonal antibody, psoriasis, Psoriasis Area and Severity Index
Abbreviations used : ADA, AE, PASI, PASI 75, PGA, TB
| Biocon Limited funded this study and supplied the drug. Employees of Biocon Limited, its affiliates, or its designees designed the study and analyzed data. The medical writing team of Biocon Limited assisted the authors in preparing this manuscript.
| Disclosure: Drs Krupashankar, Dogra, Kura, Saraswat, Leelavathy, Sumathy, Shah, Gopal, Narayana Rao, Srinivas, Bhat, Shetty, Manmohan, Sai Krishna, Padmaja, Pratap, Garg, Gupta, Pandey, and Khopkar were investigators who conducted the clinical trial described in this manuscript and collected the trial data; they received honoraria from the study sponsor. Dr Montero is a part-time employee of Biocon Research Limited. Drs Ramakrishnan, Nair, and Ganapathi are employees of Biocon Research Limited.