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

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

Make a donation

Donate Today

Help us to update and maintain DermNet New Zealand

Submit your images

We are expanding our image library

Contact us

Skin lesion photography

Watch Dr Amanda Oakley presenting "Skin lesion photography" at The Australasian Skin Cancer Congress.

Subscribe to our mailing list

* indicates required
DermNet NZ Newsletter