Home » Topics A–Z » 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.
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.
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
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.
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