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.
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).


CONCLUSIONS
No active comparator is a limitation.


CONCLUSIONS
Itolizumab is an effective and well-tolerated novel biological therapy in moderate to severe psoriasis.
Manipal Hospital, Bangalore, India.
D S
DS
Krupashankar
Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Sunil
S
Dogra
Grant Medical College and JJ Group of Hospitals, Mumbai, India.
Mahendra
M
Kura
Indushree Skin Clinic, Lucknow, India.
Abir
A
Saraswat
Bowring and Lady Curzon Hospitals, Bangalore, India.
Leelavathy
L
Budamakuntla
M S Ramaiah Memorial Hospital, Bangalore, India.
T K
TK
Sumathy
Apollo Hospital, Hyderabad, India.
Radha
R
Shah
Kempegowda Institute of Medical Sciences, Bangalore, India.
M G
MG
Gopal
King George Hospital, Visakhapatnam, India.
T
T
Narayana Rao
PSG Hospitals, Coimbatore, India.
C R
CR
Srinivas
Father Muller Medical College and Hospital, Mangalore, India.
Ramesh
R
Bhat
AJ Institute of Medical Sciences, Mangalore, India.
Narendra
N
Shetty
Derma Skin Clinic, Hyderabad, India.
G
G
Manmohan
Sri Sai Skin Clinic, Hyderabad, India.
Kotla
K
Sai Krishna
Sumana Hospital, Hyderabad, India.
Dalavoi
D
Padmaja
Durgabhai Deshmukh Hospital, Hyderabad, India.
Dasiga Venkata Subrahmanya
DV
Pratap
Maulana Azad College and Lok Nayak Hospital, New Delhi, India.
Vijay
V
Garg
Skin and Laser Center, Delhi, India.
Sandesh
S
Gupta
DermaKlinic Skin, Laser and Cosmetic Clinic, Lucknow, India.
Neeraj
N
Pandey
Seth G.S. Medical College and KEM Hospital, Mumbai, India.
Uday
U
Khopkar
Center of Molecular Immunology, Havana, Cuba; Biocon Research Limited, Bangalore, India.
Enrique
E
Montero
Biocon Research Limited, Bangalore, India.
M S
MS
Ramakrishnan
Biocon Research Limited, Bangalore, India.
Pradip
P
Nair
Biocon Research Limited, Bangalore, India. Electronic address: drprasannacg@gmail.com.
Prasanna C
PC
Ganapathi
D000293:Adolescent; D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
D061067:Antibodies, Monoclonal, Humanized
Psoriasis Area and Severity Index; anti-CD6; autoimmune disease; itolizumab; monoclonal antibody; psoriasis