Long-term efficacy and safety of itolizumab in patients with moderate-to-severe chronic plaque psoriasis: A double-blind, randomized-withdrawal, placebo-controlled.

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Presentation transcript:

Long-term efficacy and safety of itolizumab in patients with moderate-to-severe chronic plaque psoriasis: A double-blind, randomized-withdrawal, placebo-controlled study Sunil Dogra, MD, DNB, FRCP (London), Krupashankar D.S., MD, DVD, MISD, FAAD, Leelavathy Budamakuntla, MD, C.R. Srinivas, MD, Uday Khopkar, DVD, MD, DNB, Sandesh Gupta, DVD, MCSA, Narendra Shetty, MD, Dasiga Venkata Subrahmanya Pratap, MD, DD, M.G. Gopal, MD, T. Narayana Rao, MD, DD, Vijay Garg, MD, T.K. Sumathy, MD, DNB, Abir Saraswat, MD, DNB, MNAMS, Ramesh Bhat, MD, DNB, DVD, Mahendra Kura, MD, DNB, Neeraj Pandey, MD, Radha Shah, MD, FCPS, DDV (Bom), Kotla Sai Krishna, MD, DD, Dalavai Padmaja, MD, G. Manmohan, MD, DD, Ramakrishnan M.S., PhD, Abhijit Barve, MD, PhD, Enrique Montero, MD, PhD Journal of the American Academy of Dermatology Volume 73, Issue 2, Pages 331-333.e1 (August 2015) DOI: 10.1016/j.jaad.2015.03.040 Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 Itolizumab induces long-term response. A, Patients on itolizumab who reached PASI ≥ 75 at week 28 were re-randomized to placebo (group 1P [n = 39]) or to itolizumab q12w (group 1M [n = 40]) up to week 52. Depicted is the proportion of patients at week 52 with PASI ≥ 75 (clear), PASI ≥ 50 but PASI < 75 (dotted), and remainder (black). B, Partial responders (PASI ≥ 50 but <75) at week 28 (n = 59) were switched to open-label itolizumab up to week 52. Depicted is the proportion of patients achieving PASI ≥ 75 from week 28 to 1 year. Journal of the American Academy of Dermatology 2015 73, 331-333.e1DOI: (10.1016/j.jaad.2015.03.040) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Supplemental Fig 1 Study design. Weeks 1 to 12 (placebo-controlled phase): At time “0,” patients were randomized (R) to arms A, B, and C, as shown. Arm A received induction dosing (0.4 mg/kg itolizumab every week) until week 4, and thereafter 1.6 mg/kg every 2 weeks. Arm B received 1.6 mg/kg every 2 weeks and arm C received placebo. Weeks 12 to 24 (placebo crossover/treatment consolidation phase): Arms A and B were treated with 1.6 mg/kg every 4 weeks and arm C was switched from placebo to 1.6 mg/kg every 2 weeks. Week 28 Psoriasis Area and Severity Index (PASI) assessment: Based on their PASI response status, patients were reassigned to treatment arms for the final phase of the study. Weeks 28 to 52 (randomized withdrawal/open-label/maintenance phase; not shown): Patients from arm C were given maintenance itolizumab therapy. Patients from arms A and B were withdrawn from the study, received open-label treatment, or were re-randomized. The dose of itolizumab in mg/kg is given within each box. Journal of the American Academy of Dermatology 2015 73, 331-333.e1DOI: (10.1016/j.jaad.2015.03.040) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions