In a phase 3 study, the interleukin (IL)-17 blocker ixekizumab showed a similar efficacy in paediatric patients with moderate-to-severe psoriasis as previously demonstrated in adult patients .
Although the first symptoms of psoriasis symptoms present during childhood in one-third of patients, there is still an unmet need for effective and safe therapies for children and adolescents with moderate-to-severe plaque psoriasis. This was the rationale for the IXORA-PEDS study, presented at the EADV Congress by Dr Kim Papp (Probity Medical Research, Canada).
The study evaluated the efficacy and safety of ixekizumab in 203 psoriasis patients between 6 to 18 years old. In a double-blind induction period participants received ixekizumab (n=115; 40 mg, 80 mg, or 160 mg depending on body weight), etanercept (n=30; 0.8 mg/kg), or placebo (n=58) for 12 weeks. At week 12, all participants switched to open-label ixekizumab for the 60-week maintenance phase and the following extension period up to 108 weeks.
The co-primary endpoints of the study were the proportion of patients achieving a ≥ 75% improvement from baseline on their Psoriasis Area and Severity Index score (PASI 75) and a static Physician’s Global Assessment (PGA) of clear or almost clear skin (0/1) at week 12. Secondary outcomes included PASI 90, PASI 100, and an improvement of ≥ 4 for patients with an itch Numeric Rating Scale (NRS) score of ≥ 4 at baseline.
At week 12, 89% of patients treated with ixekizumab gained a PASI 75 response compared with 25% in the placebo group and 63% in the etanercept group. In the ixekizumab arm, 81% of patients achieved clear or almost clear skin according the PGA compared with 11% in the placebo group and 40% in etanercept group.
In addition, 78% of patients even achieved a PASI 90 response rate after 12 weeks, compared with 5% in the placebo group and 40% in the etanercept group. A complete clearance of skin lesions (i.e. PASI 100) was achieved by 50% of patients treated with ixekizumab, 20% of placebo-treated patients, and 17% for the etanercept group.
Therapy with the IL-17 inhibitor also led to a reduction in itch: 71% of patients treated with ixekizumab compared to 20% of placebo patients achieved an improvement in itch of ≥ 4 NRS score. As well as a clinically relevant gain in quality of life, assessed in the Children´s Dermatology Life Quality Index: 65% of patients in the ixekizumab group and 23% of placebo patients gained a Children´s Dermatology Life Quality Index result of 0/1 after 12 weeks, which means that quality of life is no longer impaired by psoriasis.
“I think particularly in paediatric patients it is important to look at the safety aspect. We did not see any surprising side effects,” said Prof. Papp. Most side effects were mild-to-moderate. One serious event was reported in the double-blind phase, which was not related to ixekizumab but to an overdose of antihistamines. “This study provides encouraging data supporting the potential for ixekizumab to become another treatment option for this patient population,” concluded Prof. Papp.
- Papp KA, et al. Late-breaking abstract D3T01.1B, EADV 2019, 9-13 Oct, Madrid, Spain.
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Table of Contents: EADV 2019
Letter from the Editor
IL-17A blocker effective in paediatric psoriasis patients
Rituximab beats mycophenolate mofetil in pemphigus vulgaris
Novel JAK1/2 inhibitor shows remarkable efficacy in alopecia areata
Acne highly influenced by climate, pollutants, and unhealthy diet
JAK inhibition plus TCS lead to high clearance rates in AD
No cancer risk with long-term use of tacrolimus, a topical calcineurin inhibitor, in children with AD
Green light for a second JAK inhibitor in AD
Topical ruxolitinib effective in vitiligo
Small molecules: interesting novel treatment options in AD
IL-1⍺ blockade: a new treatment option in AD
IL-4/IL-13 blockade leads to rapid itch reduction in adolescents
How to manage conjunctivitis in AD patients treated with a biologic
Biologics: increasingly used in paediatric dermatology
Spotlight on Psoriasis
IL-17 blocker: effective and safe in patients with comorbidities
ESPRIT registry: sharp decline in mortality in patients treated with a TNF blocker
Relationship psoriasis and NAFLD: new data on the hepato-dermal axis
Novel selective IL-23 blocker equally effective in patients with metabolic syndrome
Selective IL-23 blocker crushes fumaric acids in all assessed efficacy endpoints
No hint of teratogenicity through ixekizumab
New Insights in Photoprotection
Systemic photoprotection: a valuable addition to topical sun protection
The underestimated effect of visible light
Comorbidities more common in chronic urticaria, psoriasis, and AD
D-Dimer as future biomarker in CSU management?
Ligelizumab for CSU: symptom control and high response rates in re-treatment
Rosacea – From New Spectrum to New Therapy
New guidance on rosacea therapy according to phenotype
Best of the Posters
Above-the-neck melanoma more prone to metastases
Reduced sleep quality in dermatoses influenced by itch and pain
Anxiety and depression are common in families of AD infants
Certolizumab pegol efficacious for head and neck psoriasis
PsoBarrier EU: Large survey evaluating quality of care in Europe
Gut microbe curbs systemic inflammation in psoriasis