OFFICIAL HIGHLIGHTS

American Diabetes Association

Conference summaries


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
  • Baricitinib in combination with background topical corticosteroids significantly improved the signs and symptoms of moderate to severe atopic dermatitis compared to placebo.

Baricitinib is an oral selective Janus kinase (JAK) 1 and 2 inhibitor that effectively reduced disease severity in moderate to severe atopic dermatitis in two phase III monotherapy studies BREEZE-AD1 and BREEZE-AD2. [1]

  • The phase III study BREEZE-AD7 investigated the efficacy and safety of baricitinib in combination with topical corticosteroid (TCS) therapy in adults with moderate to severe atopic dermatitis.

Type of study, patients, and inclusion criteria

  • BREEZE-AD7 was a randomised, double-blind, placebo-controlled phase III trial.
  • Randomisation was 1:1:1 to placebo, baricitinib 2-mg, or 4-mg daily for 16 weeks.
  • The use of low-to-moderate potency TCS was allowed.
  • 329 patients were enrolled.

Primary outcome measure

  • The primary endpoint was the proportion of patients achieving Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 0 (clear) or 1 (almost clear) with a ≥2-point improvement from baseline at week 16.
  • The proportion of patients who achieved vIGA-AD score of 0 or 1, the primary endpoint, was significantly higher in the baricitinib 4-mg + TCS group than in the placebo + TCS group (30.6% versus 14.7%, P ≤0.01) (Figure).
  • There was also improvement in the primary outcome measure for the baricitinib 2-mg group (23.9%, P = 0.08), but this was not statistically significant.
  • Significantly more patients achieved an Eczema Area and Severity Index (EASI)-75 on 4-mg (47.7%, P ≤0.01) and 2-mg (43.1%, P ≤0.01) compared to placebo (22.9%) at week 16.
  • Significant improvement in itch was detected as early as week 2 for 4-mg and week 3 for 2-mg.
  • Improvements in night-time awakenings, skin pain, Dermatology Life Quality Index (DLQI), and Patient Oriented Eczema Measure (POEM) were observed by week 1 for 4-mg and by weeks 1 to 3 for 2-mg, and were maintained through week 16.
  • Baricitinib also resulted in a significant reduction in the amount of moderate potency TCS used during the study (39% and 28% (P ≤0.01) for 4-mg and 2-mg, respectively, compared to placebo).
  • Treatment-emergent adverse events were reported in 38%, 56% and 58% of patients, and serious adverse events in 3.7%, 1.8%, and 3.6% of patients on placebo, 2-mg, and 4-mg, respectively.
  • The most common adverse events were nasopharyngitis, upper respiratory tract infections, and folliculitis.
  • Baricitinib in combination with background TCS therapy significantly improved the signs and symptoms of moderate to severe atopic dermatitis compared to placebo, with a safety profile consistent with prior findings from baricitinib clinical development in atopic dermatitis.

Key messages/Clinical perspectives

  • Baricitinib may represent a potential novel treatment option for patients with moderate to severe atopic dermatitis with rapid onset of action.


References

References


  1. Simpson EL, et al. 24th World Congress of Dermatology; Milan, June 2019, Italy.

Presenter disclosure information: K Reich: AbbVie, Affibody, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, Celgene, Covagen, Eli Lilly and Company, Forward Pharma, Fresenius Medical Care, Galapagos, GlaxoSmithKline, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Medac, Merck Sharp & Dohme, Miltenyi, Novartis, Ocean Pharma, Pfizer, Samsung Bioepis, Sanofi, Takeda, UCB Pharma, Valeant, XBiotech, and Xenoport.

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
 

TEST YOUR KNOWLEDGE


After completing the program, test your knowledge with this quiz.

Keep learning Go to the QUIZ