D S Krupashankar1, Sunil Dogra2, Mahendra Kura3, Abir Saraswat4, Leelavathy Budamakuntla5, T K Sumathy6, Radha Shah7, M G Gopal8, T Narayana Rao9, C R Srinivas10, Ramesh Bhat11, Narendra Shetty12, G Manmohan13, Kotla Sai Krishna14, Dalavoi Padmaja15, Dasiga Venkata Subrahmanya Pratap16, Vijay Garg17, Sandesh Gupta18, Neeraj Pandey19, Uday Khopkar20, Enrique Montero21, M S Ramakrishnan22, Pradip Nair22, Prasanna C Ganapathi23. 1. Manipal Hospital, Bangalore, India. 2. Postgraduate Institute of Medical Education and Research, Chandigarh, India. 3. Grant Medical College and JJ Group of Hospitals, Mumbai, India. 4. Indushree Skin Clinic, Lucknow, India. 5. Bowring and Lady Curzon Hospitals, Bangalore, India. 6. M S Ramaiah Memorial Hospital, Bangalore, India. 7. Apollo Hospital, Hyderabad, India. 8. Kempegowda Institute of Medical Sciences, Bangalore, India. 9. King George Hospital, Visakhapatnam, India. 10. PSG Hospitals, Coimbatore, India. 11. Father Muller Medical College and Hospital, Mangalore, India. 12. AJ Institute of Medical Sciences, Mangalore, India. 13. Derma Skin Clinic, Hyderabad, India. 14. Sri Sai Skin Clinic, Hyderabad, India. 15. Sumana Hospital, Hyderabad, India. 16. Durgabhai Deshmukh Hospital, Hyderabad, India. 17. Maulana Azad College and Lok Nayak Hospital, New Delhi, India. 18. Skin and Laser Center, Delhi, India. 19. DermaKlinic Skin, Laser and Cosmetic Clinic, Lucknow, India. 20. Seth G.S. Medical College and KEM Hospital, Mumbai, India. 21. Center of Molecular Immunology, Havana, Cuba; Biocon Research Limited, Bangalore, India. 22. Biocon Research Limited, Bangalore, India. 23. Biocon Research Limited, Bangalore, India. Electronic address: drprasannacg@gmail.com.
Abstract
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.
RCT Entities:
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.
Authors: Yan Li; Jeffrey H Ruth; Stephanie M Rasmussen; Kalana S Athukorala; Daniel P Weber; M Asif Amin; Phillip L Campbell; Nora G Singer; David A Fox; Feng Lin Journal: Arthritis Rheumatol Date: 2020-08-14 Impact factor: 10.995