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Taltz improves skin, itch, QoL in pediatric patients with psoriasis
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Phase 3 data presented at the European Academy of Dermatology and Venereology Congress demonstrated that treatment with Taltz resulted in a 75% improvement in Psoriasis Area of Severity Index score and static Physician Global Assessment of clear or almost clear skin at 12 weeks in pediatric patients with moderate to severe plaque psoriasis.
“We may have the opportunity to provide relief and meaningful benefit to a high needs, under-treated [and] vulnerable population,” study researcher Kim Papp, MD, PhD, founder and president of Probity Medical Research in Waterloo, Ontario, Canada, told Healio Dermatology.
The study included 201 patients with moderate to severe plaque psoriasis aged 6 to 18 years. Patients were randomly assigned to 12 weeks of placebo or Taltz (ixekizumab, Eli Lilly) 20 mg (< 25 kg), 40 mg (25 to 50 kg) or 80 mg (> 50 kg) with a starting dose of 40 mg, 80 mg or 160 mg based on body weight.
The coprimary endpoints were proportion of patients achieving PASI 75 and a static PGA (sPGA) of clear or almost clear skin (0 or 1) at week 12. Secondary endpoints included proportion of patients achieving PASI 90, sPGA of 0 and PASI 100 at week 12. Additional endpoints included a 4-point or greater improvement in Itch Numeric Rating Scale (NRS) in patients with a baseline score of at least 4, and PASI 75 and sPGA of 0 or 1 at week 4, according to the release. Children’s Dermatology Life Quality Index (CDLQI; for patients aged 6 to 16 years) and Dermatology Life Quality Index (DLQI; for patients aged 17 years or older) were also assessed.
Results demonstrated that a higher proportion of patients assigned to the study drug vs. placebo achieved PASI 75, PASI 90 and PASI 100: 89% vs. 25%; 78% vs. 5% and 50% vs. 2%, respectively (P < .001 for all). Similarly, 81% of patients assigned ixekizumab achieved sPGA of 0 or 1 vs. 11% assigned to placebo (P < .001), and 52% of those in the ixekizumab group achieved sPGA of 0 vs. 2% in the placebo group (P < .001).
“We’re encouraged by the positive results we saw for Taltz with this study and pleased that Taltz is the first and only IL-17A inhibitor with published clinical trial results in pediatric patients with moderate to severe plaque psoriasis,” Rhonda Pacheco, global brand development leader, Eli Lilly & Company, added during the interview.
At week 12, ixekizumab was associated with greater response vs. placebo in Itch NRS of at least 4 (71% vs. 20%; P < .001) and the proportion of patients achieving 0 or 1 on the CDLQI and DLQI (64% vs. 23%; P < .001).
Based on this data, Pacheco added that Lilly plans to submit approval to regulatory authorities for pediatric patients with moderate to severe plaque psoriasis. – by Stacey L. Adams
Reference:
Paller A, 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. Presented at: 28th European Academy of Dermatology and Venerology Congress; Oct. 9-13, 2019; Madrid.
Disclosures: Pacheco is employed by Lilly. Papp reports he is a consultant, scientific adviser, investigator, scientific officer or speaker for AbbVie, Akros Pharma, Allergan, Amgen, Anacor, Astellas, AstraZeneca, Baxalta, Baxter, BMS, Boehringer Ingelheim, Can-Fite, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly and Co., Forward Pharma, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, Leo Pharma, MedImmune, Meiji Seika Pharma, Merck Sharp & Dohme, Merck-Serono, Mitsubishi Tanabe Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Roche, Sanofi/Genzyme, Takeda, UCB and Valeant. Please see the abstract for all other authors’ relevant financial disclosures.