IL-17A blocker effective in paediatric psoriasis patients

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 [1].

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.

1. 
   
   1. Papp KA, et al. Late-breaking abstract D3T01.1B, EADV 2019, 9-13 Oct, Madrid, Spain.

 



Posted on 9 December 201912 March 2021