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American Diabetes Association

Conference summaries


Psoriasis

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.


References

References


  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


CLINICAL TRIALS

PSORIASIS

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

ATOPIC DERMATITIS

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

PRURIGO NODULARIS

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

VITILIGO

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 TERAPIES

PSORIASIS

Emerging therapies for psoriasis

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

ATOPIC DERMATITIS

New and emerging therapies in atopic dermatitis

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

ONYCHOMYCOSIS

Emerging treatments for onychomycosis

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

REVIEW & UPDATES

ACNE & ROSACEA

Isotretinoin for acne and rosacea

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

ALOPECIA AREATA

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.

DERMATOSURGERY

Update in dermatosurgery

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

EPIDERMOLYSIS BULLOSA

New start of gene therapy in epidermolysis bullosa

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

MELANOMA

Treatment resistance in metastatic melanoma

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

SCAR TREATMENT

Future of medical scar treatment

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

EDUCATION FORUM

NON-MELANOMA SKIN CANCER

Systemic treatments of non-melanoma skin cancer

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

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