Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study

Kabashima, Kenji; Furue, Masutaka; Hanifin, Jon M.; Pulka, Grażyna; Wollenberg, Andreas; Galus, Ryszard; Etoh, Takafumi; Mihara, Ryosuke; Nakano, Miwa; Ruzicka, Thomas

doi:10.1016/j.jaci.2018.03.018

Cited by 199 publications

(143 citation statements)

References 28 publications

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“…3 Proinflammatory cytokines from T cells and keratinocytes play a key role in the pathogenesis of AD and atopic itch, as previously reviewed. [5][6][7][8][9][10][11] However, there is growing appreciation for the contribution of the nervous system in AD-associated itch. [5][6][7][8][9][10][11] However, there is growing appreciation for the contribution of the nervous system in AD-associated itch.…”

Section: Introductionmentioning

confidence: 99%

Neuroimmune interactions in chronic itch of atopic dermatitis

Yosipovitch

Berger

Fassett

2019

Acad Dermatol Venereol

102

100

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Section: Introductionmentioning

confidence: 99%

Neuroimmune interactions in chronic itch of atopic dermatitis

Yosipovitch

Berger

Fassett

2019

Acad Dermatol Venereol

102

100

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“…Participant flow through study Part A and Part B has been previously reported . Of the 264 patients in the ITT population, 138 who received placebo or nemolizumab in Part A had available WPAI‐AD data and were included in the current analysis (Table ).…”

Section: Resultsmentioning

confidence: 99%

“…Details of the study design have been reported previously . Briefly, Part A was an evaluation of four nemolizumab dose regimens (0.1, 0.5 or 2.0 mg/kg s.c. every 4 weeks [Q4W] or 2.0 mg/kg s.c. every 8 weeks [Q8W]).…”

Section: Methodsmentioning

confidence: 99%

“…18 Nemolizumab was also well tolerated, with no new safety concerns identified with long-term use. 17,18 To date, work productivity in patients with AD has not been well studied. Therefore, the objective of the current post-hoc analysis was to investigate the effects of nemolizumab on work productivity and activity impairment (WPAI) in patients with moderate to severe AD in the 12-week, placebo-controlled study (Part A) and subsequent long-term extension (Part B) using the Work Productivity and Activity Impairment -Atopic Dermatitis (WPAI-AD) questionnaire as the assessment index.…”

Section: Introductionmentioning

confidence: 91%

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Nemolizumab in moderate to severe atopic dermatitis: An exploratory analysis of work productivity and activity impairment in a randomized phase II study

Mihara¹,

Kabashima

Furue

et al. 2019

The Journal of Dermatology

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Atopic dermatitis negatively impacts work productivity. This study investigated the impact of nemolizumab on work productivity and activity impairment in adults with moderate to severe atopic dermatitis inadequately controlled by topical treatments in a two‐part, phase II, randomized control trial. The Work Productivity and Activity Impairment – Atopic Dermatitis questionnaire was an exploratory end‐point. Part A was a 12‐week, placebo‐controlled study in which patients received s.c. nemolizumab 0.1, 0.5 or 2.0 mg/kg every 4 weeks or 2.0 mg/kg every 8 weeks. Part B was a 52‐week extension in which all patients received active treatment. A total of 138 patients had Work Productivity and Activity Impairment – Atopic Dermatitis data; 104 were employed at baseline. At week 12, patients receiving nemolizumab every 4 weeks showed greater mean (standard error) Work Productivity and Activity Impairment – Atopic Dermatitis improvement (score reduction) from baseline versus placebo: Percent Work Time Missed (0.1, 0.5 or 2.0 mg/kg vs placebo): –4.0% (3.9%), –1.7% (4.2%) and –1.6% (4.2%) versus 4.9% (4.5%); Percent Impairment While Working, –15.8% (6.0%), –24.1% (6.5%) and –34.3% (6.4%) versus –16.5% (7.1%); Percent Overall Work Impairment, –16.3% (6.0%), –23.1% (6.5%) and –34.5% (6.3%) versus –16.6% (7.1%); and Percent Activity Impairment, –13.4% (5.3%), –23.5% (5.3%) and –41.9% (5.5%) versus –10.9% (5.7%). Improvements were sustained through week 64. Nemolizumab‐treated patients with moderate to severe atopic dermatitis reported improvements in Work Productivity and Activity Impairment through week 64.

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“…that is a central mediator of itch markedly reduced pruritus in two phase II studies, but had only moderate effects at EASI scores. 122,123 Targeting epithelial cytokines such as IL-17C and fezakinumab (IL-22 antibody) or IL-22R are at early stages of development. There is clear evidence that AE is a heterogeneous disease, probably comprising several endotypes.…”

Section: Future Developments: Focussing On Type 2 Immunity and Epitmentioning

confidence: 99%

New biological treatments for asthma and skin allergies

Eyerich

Metz

Bossios

et al. 2019

Allergy

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Allergies are typically endemic, complex and heterogeneous diseases with a high impact at quality of life. Mechanistically, type 2 immune responses involving eosinophil and basophil granulocytes, mast cells and humoral factors such as IgE are key drivers of allergic diseases. Fighting allergic diseases knows three strategies: prevention, symptomatic and causative therapy. While remarkable progress was made in understanding molecular events in allergies as a prerequisite for effective prevention and desensitization, this review article focuses on the most efficient symptomatic treatments—that is using more and more specific antibodies neutralizing particular immune pathways. We highlight and classify recent and upcoming developments in the three prototype chronic allergic diseases allergic asthma, chronic spontaneous urticaria and atopic eczema. In all three examples, biologics such as dupilumab or omalizumab become reliable and efficient therapeutic options. Finally, we give an outlook how a diagnostic and therapeutic workflow might look like in the near future for these three major burdens of society.

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Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study

Abstract: Nemolizumab for up to 64 weeks was efficacious and overall well tolerated in patients with moderate-to-severe atopic dermatitis inadequately controlled by topical therapy.

Cited by 199 publications

References 28 publications

Neuroimmune interactions in chronic itch of atopic dermatitis

Neuroimmune interactions in chronic itch of atopic dermatitis

Nemolizumab in moderate to severe atopic dermatitis: An exploratory analysis of work productivity and activity impairment in a randomized phase II study

New biological treatments for asthma and skin allergies

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