Key clinical-trial evidence for ixekizumab

Author: Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK); Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, June 2016. 

Introduction

Ixekizumab (Taltz®) is a humanised monoclonal immunoglobulin G antibody developed by Eli Lilly and Company that has been approved in the USA (March 2016) and Europe (April 2016) as a treatment for plaque psoriasis.

Ixekizumab is a specific inhibitor of interleukin-17A (IL-17A), a pro-inflammatory cytokine that has a role in the development of several inflammatory conditions including psoriasis.

The efficacy of ixekizumab as treatment for moderate to severe plaque psoriasis has been evaluated in three randomised placebo-controlled trials, UNCOVER-1, UNCOVER-2 and UNCOVER-3. UNCOVER-2 and UNCOVER-3, also compared ixekizumab to etanercept.

Clinical trial experience

UNCOVER-1: efficacy and adverse reactions

      (n = 226).

UNCOVER - 2: efficacy and adverse events

UNCOVER - 3: efficacy and adverse events

Table 1: Efficacy results at week 12 in evaluable adults with plaque psoriasis in trials 1, 2 and 3 

 

UNCOVER-1

UNCOVER-2

UNCOVER-3

 

Ixekizumab 80MG q2w (N = 433) n (%)

Placebo

(N = 431) n (%)

Ixekizumab 80MG q2w

(N = 351)

n (%)

Placebo

(N = 168) n (%)

Ixekizumab 80MG q2w

 (N =385)

n (%)

Placebo

(N = 193) n (%)

sPGA of ‘0’ (clear) or ‘1’ (minimal)

354 (82)

14 (3)

292 (83)

4 (2)

310 (81)

13 (7)

sPGA of ‘0’ (clear)

160 (37)

0

147 (42)

1 (1)

155 (40)

0

PASI 75

386 (89)

17 (4)

315 (90)

4 (2)

336 (87)

14 (7)

PASI 90

307 (71)

2 (1)

248 (71)

1 (1)

262 (68)

6 (3)

PASI 100

153 (35)

0

142(40)

1 (1)

 

 

N = number of patients in the intent-to-treat population

Pooled adverse event results in UNCOVER 1, 2 and 3

Adverse events

Table 2: Adverse reactions in ≥1% of the TALTZ group vs placebo in adults with plaque psoriasis in trials 1, 2 and 3

Adverse Reactions

Ixekizumab 80mg Q2W

(N = 1167) (n %)

Etanercept

(N =  287) (n %)

Placebo 

 ( N = 791)(n %)

Injection site reactions

196 (17)

32 (11)

26 (3)

Upper respiratory tract infections*

163 (14)

23 (8)

101 (13)

Nausea

23 (2)

1 (<1)

5 (1)

Tinea infections

17 (2)

0

1 (<1)

*Upper respiratory tract infections cluster includes nasopharyngitis and rhinovirus infection.

Future directions for ixekizumab

Related information

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