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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.
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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 a 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.
Uncover-1 was a prospective, double-blind, multicentre trial that consisted of 1296 patients randomly distributed in a 1:1:1 ratio to receive 80 mg ixekizumab every two weeks (Q2W), 80 mg ixekizumab every four weeks (Q4W), or placebo, respectively.
In UNCOVER-2, 1224 patients were randomly assigned to receive subcutaneous placebo (n=168), etanercept (n=358), or ixekizumab every 2 weeks (Q2W; n=351) or every 4 weeks (Q4W; n=347).
Patients in UNCOVER-3 were randomly assigned to receive placebo (n=193), etanercept (n=382), ixekizumab every 2 weeks (Q2W; n=385), or ixekizumab every 4 weeks (Q2W; n=386).
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 summarises the adverse reactions that occurred at a rate of ≥ 1% in the combined proportion of patients in the Ixekizumab group compared to etanercept and placebo during a 12-week treatment period.
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.
If you are not based in New Zealand, we suggest you refer to your national drug approval agency for further information about medicines (eg, the Australian Therapeutic Goods Administration and the US Food and Drug Administration) or a national or state-approved formulary (eg, the New Zealand Formulary and New Zealand Formulary for Children and the British National Formulary and British National Formulary for Children).
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