Taltz® (Ixekizumab)

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Ixekizumab: Efficacy in Patients with Moderate-to-Severe Plaque Psoriasis By Gender Subgroups

At week 12, PASI 75 and sPGA (0,1) response rates were significantly greater in both the IXE Q2W and IXE Q4W dosing arms compared with etanercept and placebo regardless of gender.

Efficacy in Plaque Psoriasis Clinical Trials in Gender Subgroups

The safety and efficacy of ixekizumab was established in 3 randomized, double-blind, placebo-controlled phase 3 clinical trials (UNCOVER-1, -2, and -3) in patients with moderate-to-severe plaque PsO.1 Further details on study design are available in Appendix.

At baseline in the UNCOVER-2 and -3 studies, there were no significant differences overall observed between arms in regards to gender (Tabla 1).2

Tabla 1. UNCOVER-2 and UNCOVER-3 Treatment Groups Stratified by Gender2

Gender

PBO (N=361)
n (%)

ETN (N=740)a
n (%)

IXE Q4W (N=733)
n (%)

IXE Q2W (N=736)
n (%)

Male

257 (71.2)

505 (68.2)

502 (68.5)

475 (64.5)

Female

104 (28.8)

235 (31.8)

231 (31.5)

261 (35.5)

Abbreviations: ETN = etanercept; IXE = ixekizumab; PBO = placebo; Q2W = every 2 weeks following 160 mg starting dose; Q4W = every 4 weeks following 160 mg starting dose; .

a Includes both US-sourced and non-US-sourced ETN.

The percentages of patients achieving the co-primary endpoints of PASI 75 and sPGA (0,1) at week 12 stratified by gender are presented in Tabla 2. Data are from an integrated patient database of UNCOVER-2 and -3 (placebo- and active-controlled clinical trials) and were assessed using nonresponder imputation. Compared with etanercept and placebo, patients who received ixekizumab had significant improvements in psoriasis at week 12 regardless of gender (p<.001).2

Tabla 2. Percentage of Patients Achieving PASI 75 or sPGA (0,1) in UNCOVER-2 and -3 at Week 12 by Gender Subgroup, NRI2

Efficacy Measure

Gender

PBO (N=361)
n (%)

ETN (N=740)
n (%)
a

IXE Q4W (N=733)
n (%)

IXE Q2W (N=736)
n (%)


PASI 75

Male

10 (3.9)

238 (47.1)b

404 (80.5)bc

420 (88.4)bc

Female

8 (7.7)

115 (48.9)b

190 (82.3)bc

231 (88.5)bc


sPGA (0,1)

Male

11 (4.3)

199 (39.4)b

368 (73.3)bc

391 (82.3)bc

Female

6 (5.8)

89 (37.9)b

176 (76.2)bc

211 (80.8)bc

Abbreviations: ETN = etanercept; IXE = ixekizumab; NRI = non-responder imputation; PASI 75 = Psoriasis Area and Severity Index; PBO = placebo; Q2W = every 2 weeks following 160 mg starting dose; Q4W = every 4 weeks following 160 mg starting dose.

a Includes both US-sourced and non-US-sourced ETN.

b p<.001 vs PBO.

c p<.001 vs ETN.

References

1. Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711

2. Pariser D, Heffernan M, Dennehy EB, et al. The effects of age, gender, weight, age at onset, psoriasis severity, nail involvement, and presence of psoriatic arthritis at baseline on the efficacy of ixekizumab in patients with moderate-to-severe psoriasis. Poster presented at: 75th Annual Meeting of the American Congress of Dermatology; March 3-7, 2017; Orlando, FL. https://server.aad.org/eposters/Submissions/getFile.aspx?id=4622&type=sub

Glossary

PASI 75 = 75% improvement from baseline in Psoriasis Area and Severity Index

PsO = psoriasis

sPGA = static Physician Global Assessment

Appendix

Figura 1. Induction (UNCOVER-1, -2, -3) and Maintenance (UNCOVER-1, -2) Dosing Period Study Designs1

Abbreviations: ETN = etanercept; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; IXE Q12W = ixekizumab 80 mg every 12 weeks; PBO = placebo; R = randomization; sPGA = static Physician Global Assessment.

Notes:
ETN arm was not included in UNCOVER-1.

Responders (sPGA 0 or 1) to ixekizumab at week 12 were re-randomized to receive IXE Q4W, IXE Q12W, or PBO.

Nonresponders to ETN at week 12 in UNCOVER-2 were switched to IXE Q4W (without a 160 mg starting dose) after a 4-week washout period.

Nonresponders to PBO at week 12 received a 160 mg starting dose of ixekizumab followed by IXE Q4W.

(dotted line) = relapse (sPGA≥3).

UNCOVER-3 is not represented in maintenance period design as the extension period consisted of open-label treatment with IXE Q4W.

Fecha de la última revisión: 2020 M04 06


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