Taltz ® (ixekizumab) injection

80 mg/mL

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TALTZ® (ixekizumab): Phase 3 Trial 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 seen in adults with moderate-to-severe plaque psoriasis.

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IXORA-PEDS: Trial Overview

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

IXORA-PEDS: Ixekizumab Dosing Regimen Based on Patient Weight1

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

Inclusion Criteria

IXORA-PEDS inclusion criteria were patients who

  • have a diagnosis of moderate-to-severe plaque psoriasis for at least 6-months prior to baseline
  • have a PASI score ≥12 at screening and randomization
  • have a sPGA score ≥3 at screening and randomization
  • have a BSA involvement ≥10% at screening and randomization
  • are candidates for phototherapy or systemic treatment or considered not adequately controlled by topical treatments by the investigator
  • agree to use a reliable method of birth control or remain abstinent during the study
  • assent and consent by the pediatric patient and their parent or guardian to fully participate in the activities of the clinical study, and
  • are current on all immunizations in agreement with local immunization guidelines.1

Efficacy Outcome Measures

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: 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

IXORA-PEDS: PASI 75 and sPGA (0,1) Responses Through Week 12, ITT Population, NRI2

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).

IXORA-PEDS: PASI 90/100 and sPGA (0) Responses Through Week 12, ITT Population, NRI2

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).

Week 12 responses were sustained or further improved through week 48 (see IXORA-PEDS: Efficacy Responses at Week 12 and Week 48).1

IXORA-PEDS: Efficacy Responses at Week 12 and Week 481

 

Week 12

Week 48

 

Placebo
N=56
n (%)

Ixekizumab Q4W
N=115
n (%)

Ixekizumab Q4W
N=115
n (%)

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: Safety

The safety profile overview and AEs of special interest in IXORA-PEDS are summarized in IXORA-PEDS: Adverse Events in the Double-Blind Treatment Period and Combined Treatment Periods Through the 48-Week Interim Database Lock. The authors concluded the safety profile of ixekizumab in IXORA-PEDS was generally consistent with that seen in adults with moderate-to-severe plaque psoriasis.1

IXORA-PEDS: Adverse Events in the Double-Blind Treatment Period and Combined Treatment Periods Through the 48-Week Interim Database Lock1,2

 

Double-Blind Treatment Period

Combined Treatment Periods, All Ixekizumab Safety Populationa

 

Placebo
N=56
n (%)

Ixekizumab Q4W
N=115
n (%)

Total Ixekizumab
N=196
n (%)

TEAE overall

25 (45)

64 (56)

161 (82)

TEAE by severityb

Mild

16 (29)

47 (41)

80 (41)

Moderate

9 (16)

17 (15)

72 (37)

Severe

0

0

9 (5)

Death

0

0

0

Serious AE

0

1 (1)c

13 (7)

Discontinuation due to AEs

1 (2)d

0

3 (2)e

Infections

14 (25)

37 (32)

129 (66)

Serious Infections

0

0

2 (1)f

Opportunistic Infections

0

0

0

Injection-site reactions

1 (2)

14 (12)

39 (20)

Allergic reactions/hypersensitivity

1 (2)

6 (5)

16 (8)

Potential anaphylaxis

0

0

0

Cytopenia

0

1 (1)

3 (2)

Hepatic

0

0

4 (2)

Malignancies

0

0

0

Depression

0

1 (1)

6 (3)

Interstitial Lung Disease

0

0

0

Inflammatory Bowel Disease (adjudicated)

0

1 (1)

4 (2)

Crohn's Disease

0

1 (1)

4 (2)

Ulcerative Colitis

0

0

0

Abbreviations: AE = adverse event; PY = patient-years; Q4W = every 4 weeks; TEAE = treatment-emergent adverse event.

aAll patients exposed to ixekizumab in the induction, maintenance, and extension periods through the 48-week interim database lock (253.9 total PY 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; Pityriasis rubra pilaris, n=1.

fOne each of acute otitis media and tonsillitis.

Reference

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

AE = adverse event

BSA = body surface area

CDLQI = Children's Dermatology Life Quality Index

DLQI = Dermatology Life Quality Index

NRS = numeric rating scale

PASI = 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

Q4W = every 4 weeks

sPGA = static Physician Global Assessment

Date of Last Review: April 22, 2020


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