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Taltz ® (ixekizumab) injection
80 mg/mL
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What is the efficacy and safety of Taltz® (ixekizumab) in pediatric patients with 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 observed in adults with moderate-to-severe plaque psoriasis.
IXORA-PEDS: Trial Overview
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 ratio of 2:1 to receive ixekizumab every 4 weeks (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 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
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
Please refer to the published manuscripts for additional study design details, baseline characteristics, and outcomes.1,2
A detailed visual representation of the IXORA-PEDS trial results through week 12 may be accessed here.
IXORA-PEDS: 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 (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).
Week 12 responses were sustained through week 108 (IXORA-PEDS: Efficacy Responses at Week 12, Week 48, Week 60, and Week 108).1,2
|
Week 12 |
Week 48 |
Week 60 |
Week 108 |
|
|
Placebo |
Ixekizumab Q4W |
Ixekizumab Q4W |
Ixekizumab Q4W |
Ixekizumab Q4W |
PASI 50 |
21 (38) |
106 (92)a |
106 (92) |
90 (95.7) |
89 (94.5) |
PASI 75 |
14 (25) |
102 (89)a |
103 (90) |
85 (90.0) |
86 (91.7) |
PASI 90 |
3 (5) |
90 (78)a |
95 (83) |
76 (80.3) |
74 (79.0) |
PASI 100 |
1 (2) |
57 (50)a |
63 (55) |
50 (53.2) |
52 (55.1) |
sPGA (0,1) |
6 (11) |
93 (81)a |
93 (81) |
75 (80.0) |
74 (78.3) |
sPGA (0) |
1 (2) |
60 (52)a |
65 (57) |
51 (54.2) |
49 (52.4) |
Itch NRS ≥4-point improvementb |
8 (20) |
59 (71)a |
65 (78) |
58 (82.9) |
55 (78.5) |
CDLQI/DLQI (0,1)c |
13 (23) |
74 (64)a |
87 (76) |
63 (67.0)d |
57 (60.6)e |
PatGA (0,1) |
9 (16) |
91 (79)a |
99 (86) |
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 = 50% improvement from baseline in Psoriasis Area and Severity Index; 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; PatGA = Patient’s Global Assessment of Disease Severity; Q4W = every 4 weeks; sPGA = static Physician’s Global Assessment.
Note: Missing data were imputed using nonresponder imputation for week 12 and week 48 and modified nonresponder imputation for week 60 and week 108 unless otherwise specified. For the modified nonresponder imputation, response rates were obtained through the average response rate of imputation data.
ap<.001 vs placebo.
bAssessed for patients with baseline itch NRS ≥4. Placebo, N=40; Ixekizumab Q4W, N=83 for week 12 and week 48 and N=70 for week 60 and week 108.
cCDLQI was assessed for patients 6 to 16 years of age. DLQI was assessed for patients ≥17 years of age.
dObserved data from 80 patients with data available.
eObserved data from 75 patients with data available.
IXORA-PEDS: Safety
IXORA-PEDS: Adverse Events in the Double-Blind Treatment Period and Combined Treatment Periods Through Week 108 summarizes the safety profile and adverse events of special interest in IXORA-PEDS. The authors concluded the safety profile of ixekizumab in IXORA-PEDS was generally consistent with that observed in adults with moderate-to-severe plaque psoriasis.1,2
|
Double-Blind Treatment Period |
Combined Treatment Periods, All Ixekizumab Safety Populationa |
||
Placebo |
Ixekizumab Q4W |
Total Ixekizumab |
||
n (%) |
IR per 100 Patient-Years |
|||
TEAE overall |
25 (45) |
64 (56) |
172 (87.7) |
50.2 |
TEAE by severityb |
||||
Mild |
16 (29) |
47 (41) |
81 (41.3) |
23.6 |
Moderate |
9 (16) |
17 (15) |
79 (40.3) |
23.0 |
Severe |
0 |
0 |
12 (6.1) |
3.5 |
Death |
0 |
0 |
0 |
0 |
Serious AE |
0 |
1 (1)c |
15 (7.7) |
4.4 |
Discontinuation due to AEs |
1 (2)d |
0 |
5 (2.6)e |
1.5 |
Infections |
14 (25) |
37 (32) |
145 (74.0) |
42.3 |
Serious infections |
0 |
0 |
2 (1.0)f |
0.6 |
Opportunistic infections |
0 |
0 |
0g |
0.6 |
Injection-site reactions |
1 (2) |
14 (12) |
40 (20.4) |
11.7 |
Allergic reactions/hypersensitivity |
1 (2) |
6 (5) |
20 (10.2) |
5.8 |
Potential anaphylaxis |
0 |
0 |
0 |
0 |
Cytopenia |
0 |
1 (1) |
3 (1.5)h |
0.9 |
Hepatic |
0 |
0 |
4 (2.0)i |
1.2 |
Malignancies |
0 |
0 |
1 (0.5)j |
0.3 |
Depression |
0 |
1 (1) |
8 (4.1) |
2.3 |
Interstitial lung disease |
0 |
0 |
0 |
0 |
Inflammatory bowel disease (adjudicated) |
0 |
1 (1) |
4 (2) |
1.2 |
Crohn's disease |
0 |
1 (1) |
4 (2) |
1.2 |
Ulcerative colitis |
0 |
0 |
0 |
0 |
Abbreviations: AE = adverse event; IR = incidence rate; Q4W = every 4 weeks; TEAE = treatment-emergent adverse event.
aAll patients exposed to ixekizumab in the induction, maintenance, and extension periods through the 108-week final database lock (342.81 total patient-years of exposure), including patients switched to ixekizumab from placebo or etanercept following the double-blind induction treatment period.
bPatients with multiple occurrences of the same event are counted under the highest severity.
cAccidental overdose of antihistamine.
dGuttate psoriasis.
eCrohn's disease, n=2; Astrocytoma, n=1; Pityriasis rubra pilaris, n=1; Psoriasis, n=1.
fOne each of acute otitis media and tonsillitis.
gOne each of varicella zoster virus infection and herpes simplex virus infection were reported. Both infections were mild, and neither event met the criteria for an opportunistic infection as defined in the program safety analysis plan.
hIncludes broad and narrow grades of neutropenia and leukopenia.
iIncludes cases of transaminitis, elevated blood alkaline phosphatase, increased hepatic enzymes, and hepatic steatosis.
jAstrocytoma.
Enclosed Prescribing Information
References
The published references below are 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. Published online April 13, 2022. https://dx.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 ixekizumab in a phase 3, randomized, double-blind, placebo-controlled study in pediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS) up to 108 weeks. Poster presented at: Annual Meeting of the American Academy of Dermatology (AAD); March 25-29, 2022; Boston, MA.
Date of Last Review: April 18, 2022