Taltz ® (ixekizumab) injektion

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Taltz®▼ (ixekizumab): Effekt av kön hos psoriasispatienter

Vid vecka 12 var responsfrekvensen PASI 75 och sPGA (0,1) signifikant högre i båda doseringsarmarna IXE Q2W och IXE Q4W jämfört med etanercept och placebo oavsett kön.

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 Figure 1.

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

Table 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 Table 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

Table 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.

The dosing schedule IXEQ4W during the first 12 weeks of treatment (induction phase) is not consistent with the approved dosing schedule for plaque psoriasis in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing. 3

Therapeutic Indication

Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.3

References

1. Gordon KB, Blauvelt A, Papp KA, et al. 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

3. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

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

PsO = psoriasis

sPGA = static Physician Global Assessment

Appendix

Figure 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.

 The dosing schedule IXEQ12W is not consistent with the approved dosing schedule for plaque psoriasis in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing.3

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2020 M04 06


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