Conference summaries


Efficacy and safety of ixekizumab in a phase 3, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis

Presented by: Prof. Kim A. Papp Department of Medicine, Division of Dermatology, University of Toronto, Toronto, Canada
  • In paediatric patients with moderate-to-severe plaque psoriasis, ixekizumab was superior to placebo in improving skin, itch and health-related quality of life, with no unexpected safety findings.

Ixekizumab (IXE) is a high-affinity monoclonal antibody that selectively targets interleukin-17A, and which has been approved for treatment of moderate-to-severe plaque psoriasis in adult patients. [1] There is an unmet medical need for effective and safe therapies for children and adolescents with moderate-to-severe plaque psoriasis.

  • This randomised, double-blind phase III study (NCT03073200) evaluated the efficacy and safety of IXE in paediatric patients with moderate-to-severe plaque psoriasis.

Type of study, patients, and inclusion criteria

  • Patients (6 to <18 years of age) with moderate-to-severe plaque psoriasis (Psoriasis Area and Severity Index (PASI) ≥12, static Physician’s Global Assessment (sPGA) ≥3, and body surface area involvement ≥10%) were randomised (2:1) to IXE every 4 weeks (Q4W) (N=115) or placebo (PBO) (N=56).
  • Patients randomised to IXE received 40 mg (<25 kg), 80 mg (25 to 50 kg), or 160 mg (>50 kg) starting doses (based on body weight), then 20 mg, 40 mg, or 80 mg (respectively) IXE Q4W through week 12
  • An active reference arm, etanercept (ETN), was also used.

Primary outcome measure

  • Co-primary endpoints were the proportion of patients achieving 75% improvement from baseline in PASI (PASI 75) and sPGA of clear or almost clear skin (sPGA 0,1) at week 12.
  • Overall, 98% (IXE), 97% (ETN) and 95% (PBO) of patients completed week 12 assessments; thus, the co-primary endpoints were achieved.
  • At week 12, IXE was superior to PBO for PASI 75/90/100 (IXE: 89%/78%/50%, PBO: 25%/5%/2%, P <0.001), sPGA 0,1 (IXE: 81%, PBO: 11%, P <0.001) and sPGA 0 (IXE: 52%, PBO: 2%, P <0.001) responses. At week 4, IXE was superior to PBO for PASI 75 (IXE: 54%, PBO: 9%, P <0.001) and sPGA 0,1 (IXE: 46%, PBO: 6%, P <0.001) (Figure).
  • IXE resulted in significantly (P <0.001) greater responses at week 12 for both Itch NRS ≥4 (IXE: 71%, PBO: 20%) and CLDQI/DLQI 0,1 (IXE: 64%, PBO: 23%).
  • Among patients receiving ETN, PASI 75/90/100 responses were 63%/40%/17%; sPGA (0,1) response was 53%; and sPGA (0) response was 17%.
  • Treatment-emergent adverse events (TEAEs) occurred in 45% (PBO) and 56% (IXE) of patients; none were severe.
  • The most common TEAEs in the IXE group (occurring in ≥10% of IXE-treated patients) were nasopharyngitis (11.3%) and headache (10.4%).
  • Significantly more patients treated with ixekizumab versus placebo achieved PASI 75 and sPGA (0,1) as early as week 4.
  • Most adverse events were mild or moderate in severity and the safety profile was generally consistent with that seen in adults with moderate-to-severe plaque psoriasis.

Key messages/Clinical perspectives

  • IXE was superior to PBO in improving skin, itch and health-related quality of life in paediatric patients with moderate-to-severe plaque psoriasis, with no unexpected safety findings.



  1. Liu L, Lu J, Allan BW, et al. Generation and characterization of ixekizumab, a humanized monoclonal antibody that neutralizes interleukin-17A. J Inflamm Res. 2016 Apr 19;9:39-50.

Presenter disclosure information: KA Papp: Amgen, Anacor, AbbVie, Akros Pharma, Allergan, Astellas, AstraZeneca, Baxalta, Baxter, BMS, Boehringer Ingelheim, Can-Fite, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly and Company, 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.

Medical writer: Patrick Moore, PhD

Reviewer: Martina Lambertini, MD

Local reviewers: Martina Lambertini, MD (Italian); Alain Brassard, MD (French); Jorge Moreno González, MD (Spanish); Swen Malte John, MD, PhD (German); Marcelo Arnone, MD (Portuguese)

Scientific Editor: Prof. Brigitte Dréno, MD



Efficacy and safety of ixekizumab in a phase 3, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis

Presented by: Prof. Kim A. Papp, Department of Medicine, Division of Dermatology, University of Toronto, Toronto, Canada


Efficacy and safety of baricitinib in combination with topical corticosteroids in moderate to severe atopic dermatitis: results of a phase 3 randomized, double-blind, placebo-controlled 16-week trial (BREEZE-AD7)

Presented by: Prof. Kristian Reich, Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation® Center, Hamburg, Germany


Phase 2b study of nemolizumab in patients with moderate to severe prurigo nodularis and associated severe pruritus

Presented by: Prof. Sonja Ständer, Department of Dermatology and Center for Chronic Pruritus (KCP), University Hospital Münster, Germany


Efficacy and safety of a 52-week, randomized, double-blind trial of ruxolitinib cream for the treatment of vitiligo

Presented by: Dr. Amit G. Pandya, University of Texas Southwestern Medical Center, Dallas, TX, USA



Emerging therapies for psoriasis

Presented by: Prof. Michel Gilliet, Department of Dermatology, Lausanne CHUV, Switzerland


New and emerging therapies in atopic dermatitis

Presented by: Prof. Dagmar Simon, Department of Dermatology, Inselspital, Bern University Hospital, Bern, Switzerland


Emerging treatments for onychomycosis

Presented by: Dr. Ditte Marie L. Saunte, Department of Dermatology, Institute for Clinical Medicine, Zealand University Hospital, Roskilde, Denmark



Isotretinoin for acne and rosacea

Presented by: Dr. Pedro Mendes-Bastos, Dermatology Centre, Hospital CUF Descobertas, Lisbon, Portugal


New drugs for alopecia areata

Presented by: Prof. Spyridon Gkalpakiotis, Department of Dermatovenereology, Third Faculty of Medicine and University Hospital of Kralovske Vinohrady, Prague, Czech Republic.


Update in dermatosurgery

Presented by: Prof. Eduardo Nagore, Department of Dermatology, Instituto Valenciano de Oncología, Valencia, Spain


New start of gene therapy in epidermolysis bullosa

Presented by: Prof. Leena K. Bruckner-Tuderman, University Medical Center, Albert-Ludwigs-University of Freiburg, Germany


Treatment resistance in metastatic melanoma

Presented by: Prof. Martin Röcken, Department of Dermatology, Eberhard-Karls-University Tübingen, Germany


Future of medical scar treatment

Presented by: Prof. Gabriella Fabbrocini, Department of Dermatology, University of Naples Federico II, Naples, Italy



Systemic treatments of non-melanoma skin cancer

Presented by: Prof. Henrik F. Lorentzen, Department of Dermatology, Aarhus University Hospital, Denmark


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