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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 - 14/08/14

Doi : 10.1016/j.jaad.2014.01.897 
D.S. Krupashankar, MD, DVD, MISD, FAAD a, Sunil Dogra, MD, DNB, FRCP (London) b, Mahendra Kura, MD, DNB c, Abir Saraswat, MD, DNB, MNAMS d, Leelavathy Budamakuntla, MD e, T.K. Sumathy, MD, DNB f, Radha Shah, MD, FCPS, DDV (Bom) g, M.G. Gopal, MD h, T. Narayana Rao, MD, DD i, C.R. Srinivas, MD l, Ramesh Bhat, MD, DNB, DVD m, Narendra Shetty, MD n, G. Manmohan, MD, DD o, Kotla Sai Krishna, MD, DD p, Dalavoi Padmaja, MD q, Dasiga Venkata Subrahmanya Pratap, MD, DD r, Vijay Garg, MD s, Sandesh Gupta, DVD, MCSA t, Neeraj Pandey, MD u, Uday Khopkar, DVD, MD, DNB v, Enrique Montero, MD, PhD j, k, M.S. Ramakrishnan, PhD k, Pradip Nair, PhD k, Prasanna C. Ganapathi, MD k,
a Manipal Hospital, Bangalore, India 
b Postgraduate Institute of Medical Education and Research, Chandigarh, India 
c Grant Medical College and JJ Group of Hospitals, Mumbai, India 
d Indushree Skin Clinic, Lucknow, India 
e Bowring and Lady Curzon Hospitals, Bangalore, India 
f M S Ramaiah Memorial Hospital, Bangalore, India 
g Apollo Hospital, Hyderabad, India 
h Kempegowda Institute of Medical Sciences, Bangalore, India 
i King George Hospital, Visakhapatnam, India 
j Center of Molecular Immunology, Havana, Cuba 
k Biocon Research Limited, Bangalore, India 
l PSG Hospitals, Coimbatore, India 
m Father Muller Medical College and Hospital, Mangalore, India 
n AJ Institute of Medical Sciences, Mangalore, India 
o Derma Skin Clinic, Hyderabad, India 
p Sri Sai Skin Clinic, Hyderabad, India 
q Sumana Hospital, Hyderabad, India 
r Durgabhai Deshmukh Hospital, Hyderabad, India 
s Maulana Azad College and Lok Nayak Hospital, New Delhi, India 
t Skin and Laser Center, Delhi, India 
u DermaKlinic Skin, Laser and Cosmetic Clinic, Lucknow, India 
v Seth G.S. Medical College and KEM Hospital, Mumbai, India 

Reprint requests: Prasanna C. Ganapathi, MD, Biocon Research Limited–SEZ Unit, Biocon Special Economic Zone, Plot No. 2 and 3, Phase IV-B.I.A., Bommasandra–Jigani Link Road, Bangalore 560 099, India.

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.

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


Plan


 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.


© 2014  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 71 - N° 3

P. 484-492 - septembre 2014 Retour au numéro
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