OFFICIAL HIGHLIGHTS

American Diabetes Association

Conference summaries


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
  • Nemolizumab resulted in a rapid and clinically relevant improvement of pruritus and nodular lesions in PN with rapid onset of action.
  • Nemolizumab appears to be well tolerated.

Prurigo nodularis (PN) is a subtype of chronic prurigo that is highly pruritic, chronic, difficult to treat and associated with high disease burden. [1] The pathogenesis of PN is not completely understood, although inflammatory pathways have strongly implicated the involvement of IL-31. [2] Nemolizumab is a humanised monoclonal antibody targeting the IL-31 receptor alpha subunit that is under development for treatment of severe pruritic skin diseases.

  • This phase II study investigated the efficacy and safety of nemolizumab in moderate-to-severe PN and associated severe pruritus.

Type of study, patients, and inclusion criteria

  • Multicentre (20 sites, EU), randomised, double-blinded, placebo-controlled, parallel group study.
  • Patients had to have had a clinical diagnosis of PN for at least 6 months, with least 20 nodules on the body with bilateral distribution and severe pruritus (NRS (Numerical Rating Scale) ≥7).
  • A total of 70 patients were randomised to placebo (N=36) or nemolizumab (N=34).

Primary outcome measure

  • The primary endpoint was percent reduction from baseline in peak pruritus NRS at week 4.
  • Overall, baseline characteristics were similar between groups.
  • Changes in the primary endpoint, percent change in peak pruritus NRS, were significant within week 1 and remained significant at all time points thereafter.
  • The absolute change in peak pruritus NRS at week 12 was-5.2 for nemolizumab vs -1.7 for placebo; P ≤0.001.
  • 4-point peak pruritus NRS responder rate at week 12 was 52.9% for nemolizumab vs 8.3% for placebo: Δ-44.6, P <0.001; ITT (Figure).
  • There was no difference in peak pruritus between patients with and without atopic predisposition.
  • At week 18, significantly more patients reached IGA success with nemolizumab (44.1% than with placebo (5.6%; P = 0.001).
  • At week 18, significantly more patients achieved PASI75 with nemolizumab (38.2% than with placebo (8.4%; P <0.001).
  • Nemolizumab was also associated with significant improvement in sleep disturbance from baseline vs placebo.
  • In the nemolizumab group 5.9% of patients discontinued the study medication for an adverse event vs 5.6% for placebo.
  • Overall, the adverse event profile was similar between groups.
  • Nemolizumab resulted in a rapid and clinically relevant improvement of pruritus and nodular lesions in PN with onset of effect on pruritus as early as week 1 with 38% of patients clear or almost clear of skin lesions.
  • Nemolizumab was significantly more effective than placebo in all clinical endpoints
  • Nemolizumab was well tolerated with a similar safety profile vs placebo.

Key messages/Clinical perspectives

  • Nemolizumab demonstrated highly encouraging results compared to placebo in treatment of PN in phase II trials, warranting additional studies.


References

References


  1. Zeidler C, Tsianakas A, Pereira M, et al. Chronic Prurigo of Nodular Type: A Review. Acta Derm Venereol. 2018 Feb 7;98(2):173-9.
  2. Sonkoly E, Muller A, Lauerma AI, et al. IL-31: a new link between T cells and pruritus in atopic skin inflammation. J Allergy Clin Immunol. 2006 Feb;117(2):411-7.

Presenter disclosure information: S Ständer: has received research funds from DFG, EADV, BMBF, and IZKF and has served as a consultant for Almirall, Bayer, Beiersdorf, Bellus Health, Bionorica, Cara Therapeutics, Celgene, DS Biopharma, Galderma, Kneipp, Maruho, Menlo Therapeutics, Marz, NeRRe Therapeutics, Novartis, Nuformix, Perrigo, Sienna Therapeutics, ACO HUD Nordic, Toray, Trevi Therapeutics and as an investigator for Dermasence, Galderma, Kiniksa, Menlo Therapeutics, Trevi Therapeutics, Novartis, Sanofi, Vanda Therapeutics.

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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