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Taltz ® (ixekizumab) injection
80 mg/mLThis information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
TALTZ® (ixekizumab): Efficacy in Pediatric Patients With Moderate-to-Severe Plaque Psoriasis
Significantly more pediatric patients treated with ixekizumab vs placebo achieved PASI 75 and sPGA (0,1) as early as week 4 in IXORA-PEDS. The safety profile was generally consistent with that seen in adults with moderate-to-severe plaque psoriasis.
US_cFAQ_IXE201_GENERAL_EFFICACY_PEDS
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IXORA-PEDS: Clinical Trial in Pediatric Patients
Study Design
IXORA-PEDS is an ongoing, multicenter, randomized, double-blind, placebo-controlled phase 3 study designed to evaluate the efficacy and safety of ixekizumab in pediatric patients aged 6 to <18 years with moderate-to-severe plaque psoriasis.1
Patients were randomized 2:1 to receive ixekizumab Q4W (N=115) or placebo (N=56). Patients randomized to ixekizumab were dosed based on body weight categories as shown in IXORA-PEDS: Ixekizumab Dosing Regimen Based on Patient Weight. In select countries outside the United States, where etanercept is approved for severe pediatric psoriasis, 30 patients were randomized to open-label etanercept and dosed according to the etanercept label.1
Patient Weight |
Starting Dose (Week 0) |
Dose Q4W Thereafter |
<25 kg |
40 mg |
20 mg |
25 to 50 kg |
80 mg |
40 mg |
>50 kg |
160 mg (two 80 mg injections) |
80 mg |
Abbreviation: Q4W = every 4 weeks.
Following the double-blind treatment period, patients are allowed to transition to an open-label maintenance period where all patients, regardless of initial treatment, received ixekizumab Q4W (dose based on patient weight) through week 60.1
Efficacy Endpoints
The coprimary efficacy endpoints were the proportion of patients achieving PASI 75 and sPGA (0,1) at week 12. The gated secondary endpoints were
- PASI 90 at week 12
- sPGA (0) at week 12
- PASI 100 at week 12
- Itch NRS ≥4-point improvement at week 12
- PASI 75 at week 4, and
- sPGA (0,1) at week 4.1
IXORA-PEDS: Week 12 Efficacy
The coprimary and all gated secondary endpoints were achieved in IXORA-PEDS. As shown in IXORA-PEDS: PASI 75 and sPGA (0,1) Responses Through Week 12, ITT Population, NRI, significantly (p<.001) more patients treated with ixekizumab than placebo-treated patients achieved PASI 75 and sPGA (0,1) at week 4 and all assessment time points through week 12 (primary endpoint).1
Ixekizumab was also superior to placebo (p<.001) in PASI 90, PASI 100, and sPGA (0) at week 4 and all assessments through week 12 (see IXORA-PEDS: PASI 90/100 and sPGA (0) Responses Through Week 12, ITT Population, NRI).1
Moreover, ixekizumab was superior to placebo in ≥4-point improvement in itch at week 1 (p<.01) and CDLQI/DLQI at week 4 (p<.001) and at all assessments for both patient-reported outcomes through week 12.2
Abbreviations: ITT = intent-to-treat; IXE = ixekizumab; NRI = nonresponder imputation; PASI 75 = 75% improvement from baseline in Psoriasis Area and Severity Index; PBO = placebo; Q4W = every 4 weeks; sPGA = static Physician Global Assessment.
‡ p<.001 vs placebo (Fisher’s exact test).
Abbreviations: ITT = intent-to-treat; IXE = ixekizumab; NRI = nonresponder imputation; PASI 90/100 = 90%/100% improvement from baseline in Psoriasis Area and Severity Index; PBO = placebo; Q4W = every 4 weeks; sPGA = static Physician Global Assessment.
‡ p<.001 vs placebo (Fisher’s exact test).
IXORA-PEDS: Week 48 Efficacy
Week 12 responses were sustained or further improved through week 48 (see IXORA-PEDS: PASI 75 (Top Graph) and sPGA (0,1) (Bottom Graph) Response Rates Through Week 48, ITT Population, NRI and IXORA-PEDS: Efficacy Responses at Week 12 and Week 48).1
Abbreviations: ITT = intent-to-treat; IXE = ixekizumab; NRI = nonresponder imputation; PASI 75 = 75% improvement from baseline in Psoriasis Area and Severity Index; PBO = placebo; Q4W = every 4 weeks; sPGA = static Physician Global Assessment.
*p<.05 vs placebo.
‡ p<.001 vs placebo.
|
Week 12 |
Week 48 |
|
|
Placebo |
Ixekizumab Q4W |
Ixekizumab Q4W |
PASI 50 |
21 (38) |
106 (92)a |
106 (92) |
PASI 75 |
14 (25) |
102 (89)a |
103 (90) |
PASI 90 |
3 (5) |
90 (78)a |
95 (83) |
PASI 100 |
1 (2) |
57 (50)a |
63 (55) |
sPGA (0,1) |
6 (11) |
93 (81)a |
93 (81) |
sPGA (0) |
1 (2) |
60 (52)a |
65 (57) |
Itch NRS ≥4-point improvementb |
8 (20) |
59 (71)a |
65 (78) |
CDLQI/DLQI (0,1)c |
13 (23) |
74 (64)a |
87 (76) |
PatGA (0,1) |
9 (16) |
91 (79)a |
99 (86) |
Abbreviations: CDLQI = Children’s Dermatology Life Quality Index; DLQI = Dermatology Life Quality Index; NRS = numeric rating scale; PASI = Psoriasis Area and Severity Index; PatGA = Patient’s Global Assessment of Disease Severity; Q4W = every 4 weeks; sPGA = static Physician’s Global Assessment.
ap<.001 vs placebo.
bAssessed for patients with baseline itch NRS ≥4. Placebo, N=40; Ixekizumab Q4W, N=83.
cCDLQI was assessed for patients 6 to 16 years of age. DLQI was assessed for patients ≥17 years of age.
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Paller AS, Seyger MMA, Magariños GA, et al. Efficacy and safety of ixekizumab in a phase 3, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS). Br J Dermatol. Published online April 21, 2020. https://doi.org/10.1111/bjd.19147
2Paller AS, Seyger MMB, Magariños GA, et al. Efficacy and safety of ixekizumab in a phase 3, randomized, double-blind, placebo-controlled study in pediatric patients with moderate-to-severe plaque psoriasis. Talk presented at: 28th Annual Meeting of the European Academy of Dermatology and Venereology; October 9-13, 2019; Madrid, Spain.
Glossary
CDLQI = Children's Dermatology Life Quality Index
DLQI = Dermatology Life Quality Index
NRS = numeric rating scale
PASI 75 = 75% improvement from baseline in Psoriasis Area and Severity Index
PASI 90 = 90% improvement from baseline in Psoriasis Area and Severity Index
PASI 100 = 100% improvement from baseline in Psoriasis Area and Severity Index
Q4W = every 4 weeks
sPGA = static Physician Global Assessment
Date of Last Review: May 28, 2020
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