If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
Taltz ® (ixekizumab) injection
80 mg/mL
This 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.
What is the efficacy of Taltz® (ixekizumab) 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 and the responses were sustained or further improved through week 108 in the IXORA-PEDS clinical trial.
IXORA-PEDS: Clinical Trial in Pediatric Patients
Study Design
IXORA-PEDS was a 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.1,2
Patients were randomized in a 2:1 ratio to receive ixekizumab every 4 weeks (Q4W) (N=115) or placebo (N=56). Patients who were randomized to ixekizumab were dosed based on body weight categories as shown in IXORA-PEDS: Ixekizumab Dosing Regimen Based on Patients' Body 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
Patients' Body 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 entered an open-label maintenance period where all patients, regardless of initial treatment, received ixekizumab Q4W (dose based on patients' body weight) through week 60.1 Following the maintenance period, patients continued on open-label ixekizumab Q4W through week 108 in the extension period.2
Efficacy Endpoints
The coprimary efficacy endpoints were the proportion of patients achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician Global Assessment (sPGA) score of 0 or 1 [sPGA (0,1)] at week 12. The gated secondary endpoints were
- 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at week 12
- sPGA (0) at week 12
- 100% improvement from baseline in Psoriasis Area and Severity Index (PASI 100) at week 12
- itch numeric rating scale (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, PASI 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 Children's Dermatology Life Quality Index (CDLQI)/Dermatology Life Quality Index (DLQI) at week 4 (p<.001) and at all assessments for both patient-reported outcomes through week 12.3
Figure 1 description: 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.
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).
Figure 2 description: Significantly (p<.001) more patients treated with ixekizumab than placebo-treated patients achieved PASI 90, PASI 100, and sPGA (0) at week 4 and all assessment time points through week 12.
Abbreviations: ITT = intent-to-treat; IXE = ixekizumab; NRI = nonresponder imputation; PASI 90 = 90% improvement from baseline in Psoriasis Area and Severity Index; PASI 100 = 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 (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 Placebo |
Week 12 Ixekizumab Q4W |
Week 48 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.
IXORA-PEDS: Week 108 Efficacy
In the IXORA-PEDS clinical trial, patients achieved primary and gated secondary endpoints by week 12 and sustained through week 60 and week 108 (IXORA-PEDS: Efficacy at Week 60 and Week 108).4
All ixekizumab populations at combined treatment perioda |
||
Week 60 |
Week 108 |
|
PASI 50 |
90 (95.7) |
89 (94.5) |
PASI 75 |
85 (90.0) |
86 (91.7) |
PASI 90 |
76 (80.3) |
74 (79.0) |
PASI 100 |
50 (53.2) |
52 (55.1) |
sPGA (0,1) |
75 (80) |
74 (78.3) |
sPGA (0) |
51 (54.2) |
49 (52.4) |
Itch NRS ≥4-point improvement |
58 (82.9)c |
55 (78.5)c |
CDLQI/DLQI (0,1) |
63 (67.0)d |
67 (60.6)e |
PatGA (0,1) |
79 (83.9) |
79 (83.5) |
Abbreviations: CDLQI = Children’s Dermatology Life Quality Index; DLQI = Dermatology Life Quality Index; NRS = numeric rating scale; PASI 50/75/90/100 = 50%/75%/90%/100% improvement from baseline in Psoriasis Area and Severity Index; PatGA = Patient’s Global Assessment of Disease Severity; sPGA = static Physician’s Global Assessment.
aAll patients who were randomized to ixekizumab at week 0 (visit 2) and who received ixekizumab throughout their study participation. Missing data were imputed using modified nonresponder imputation unless otherwise specified. For results imputed by modified nonresponders imputation, response rates were obtained through the average response rate of imputation data.
bUnless stated otherwise.
cN=70.
dN=80.
eN=75.
PASI 75, PASI 90, PASI 100, sPGA (0,1), and sPGA (0) responses were sustained or further improved through week 108 (IXORA-PEDS: PASI 75/90/100 Responses Achieved by Week 12 Were Sustained Through Week 108 With Ixekizumab, mNRI and IXORA-PEDS: sPGA (0,1) and sPGA (0) Week 12 Responses Were Sustained Through Week 108 With Ixekizumab).4
Figure 4 description: In the IXORA-PEDS clinical trial, PASI 75/90/100 were sustained through week 108.
Abbreviations: IXE = ixekizumab; mNRI = modified nonresponder imputation; PASI 75/90/100 = 75%/90%/100% improvement from baseline in Psoriasis Area and Severity Index; Q4W = every 4 weeks.
Figure 5 description: In the IXORA-PEDS clinical trial, sPGA (0,1) and sPGA (0) week 12 responses were sustained through week 108.
Abbreviations: IXE = ixekizumab; mNRI = modified nonresponder imputation; Q4W = every 4 weeks; sPGA = static Physician Global Assessment; W = week.
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Paller AS, Seyger MMB, Magariños GA, et al; IXORA-PEDS Study Group. Efficacy and safety of ixekizumab in a phase III, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS). Br J Dermatol. 2020;183(2):231-241. https://doi.org/10.1111/bjd.19147
2Paller AS, Seyger MMB, Magariños GA, et al; IXORA-PEDS Investigators. Long-term efficacy and safety of up to 108 weeks of ixekizumab in pediatric patients with moderate to severe plaque psoriasis: the IXORA-PEDS randomized clinical trial. JAMA Dermatol. 2022;158(5):533-541. https://doi.org/10.1001/jamadermatol.2022.0655
3Paller 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. Abstract presented at: 28th Annual Meeting of the European Academy of Dermatology and Venereology (EADV Virtual); October 9-13, 2019; Madrid, Spain.
4Paller AS, Seyger MMB, Magariños GA, et al. Long-term efficacy and safety of up to 108 weeks of ixekizumab in pediatric patients with moderate to severe plaque psoriasis (IXORA-PEDS). JAMA Dermatology. 2022;158(5):533-541. https://doi.org/10.1001/jamadermatol.2022.0655
Date of Last Review: August 22, 2022