Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis: Subgroup analysis of Latin American patients in the phase 3 randomized UNCOVER-3 study.
OBJECTIVE
Ixekizumab demonstrated greater efficacy than placebo and etanercept in UNCOVER-3. Subgroup analysis of Latin American patients was performed. We report 12-week and 60-week data.


METHODS
Analysis included 102 Latin American patients randomized to receive placebo (n=14), etanercept 50mg twice weekly (n=30), or ixekizumab 160-mg starting dose followed by 80mg every 2 weeks (Q2W; n=29) or every 4 weeks (Q4W; n=29). At week 12, patients maintaining efficacy response and adequate overall safety were assigned, at the discretion of the investigator, to long-term extension with ixekizumab Q4W.


RESULTS
At week 12, Psoriasis Area and Severity Index (PASI) 100 scores were 0%, 20.0% (p=0.075 vs placebo), 62.1% (p<0.001 vs placebo; p=0.001 vs etanercept), and 48.3% (p=0.002 vs placebo; p=0.023 vs etanercept) for placebo, etanercept, ixekizumab Q2W, and ixekizumab Q4W, respectively. Among patients who continued therapy up to week 60 (n=97), PASI 100 scores were 71.4%, 60.0%, 77.8%, and 57.7% for patients who received induction placebo, etanercept, ixekizumab Q2W, and ixekizumab Q4W, respectively (non-responder imputation). By week 60, ≥1 serious adverse event was experienced by 7.1% (n=1/14), 3.3% (n=1/30), 14.8% (n=4/27), and 0% (n=0/26) of patients who received induction placebo, etanercept, ixekizumab Q2W, and ixekizumab Q4W, respectively. There were no cases of active tuberculosis with ixekizumab treatment through 60 weeks.


CONCLUSIONS
In Latin American patients, both ixekizumab dosing regimens demonstrated greater efficacy than etanercept for treating psoriasis over 12 weeks. The safety profile of ixekizumab through 60 weeks was well tolerated and consistent with the overall profile.
Departamento de Dermatología, Facultad de Medicina Universidad de Chile, Probity Medical Research, Santiago, Chile.
F
F
Valenzuela
Clinica Dermacross, Santiago, Chile.
C
C
de la Cruz Fernandez
Universidad de Buenos Aires Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
R L
RL
Galimberti
Eli Lilly and Company, Indianapolis, USA.
S
S
Gürbüz
inVentiv Health, USA.
M
M
McKean-Matthews
Eli Lilly and Company, São Paulo, Brazil. Electronic address: lgoncalves@lilly.com.
L
L
Goncalves
Department of Dermatology, Hospital das Clínicas de Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
R
R
Romiti
D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001118:Argentina; D002677:Chile; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D023381:Endpoint Determination; D000068800:Etanercept / Q000009:adverse effects / Q000627:therapeutic use*; D005006:Ethnicity; D005260:Female; D006801:Humans; D008297:Male; D008800:Mexico; D008875:Middle Aged; D010919:Placebos / Q000009:adverse effects; D011565:Psoriasis / Q000188:drug therapy*; D016896:Treatment Outcome
D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; D010919:Placebos; C549079:ixekizumab; D000068800:Etanercept
Ixekizumab; Latin America; Latinoamérica; Psoriasis; Soriasis