Evaluation of a Janus kinase 1 inhibitor, PF‐04965842, in healthy subjects: A phase 1, randomized, placebo‐controlled, dose‐escalation study

Peeva, Elena; Hodge, Martin R.; Kieras, Elizabeth; Vazquez, Michael L.; Goteti, Kosalaram; Tarabar, Sanela; Alvey, Christine; Banfield, Christopher

doi:10.1111/bcp.13612

Cited by 41 publications

(58 citation statements)

References 36 publications

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“…Blood samples for analyses of hsCRP, a biomarker of Jak1 inhibition downstream of IL-6, and IP-10, a biomarker of Jak1 inhibition downstream of IFN-g (Peeva et al, 2018), were collected at specified study visits (weeks 1, 2, 4, 8, and 12 of the study period and weeks 14 and 16 of the follow-up period). Samples were analyzed for hsCRP using an immunonephelometry assay with a measuring range of 0.020e0.955 mg/dl.…”

Section: Safety Assessmentsmentioning

confidence: 99%

TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial

Forman¹,

Pariser

Poulin

et al. 2020

Journal of Investigative Dermatology

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Section: Safety Assessmentsmentioning

confidence: 99%

TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial

Forman¹,

Pariser

Poulin

et al. 2020

Journal of Investigative Dermatology

Self Cite

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“…The Phase I study (NCT01835197) evaluated abrocitinib safety, tolerability, pharmacokinetics and pharmacodynamics in 79 healthy adults. 24 This was a single-center, double-blind (subject and investigator), and sponsor open study. 24 The patients received a single ascending dose phase (SAD) of placebo or 3, 10, 30, 100, 200, 400, or 800 mg of abrocitinib and placebo or 30 mg once daily, 100 mg once daily, 200 mg once daily, 400 mg once daily, 100 mg twice daily, or 200 mg twice daily of abrocitinib for 10 consecutive days [multiple ascending dose phase] (MAD).…”

Section: Resultsmentioning

confidence: 99%

The Efficacy and Safety of Abrocitinib as a Treatment Option for Atopic Dermatitis: A Short Report of the Clinical Data

Napolitano¹,

Fabbrocini²,

Ruggiero³

et al. 2021

DDDT

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Atopic dermatitis (AD) is a chronic, pruritic, inflammatory skin disease that predominantly affects children. However, it can persist in adulthood and/or start at older ages. Both dysfunction of the epidermal barrier and immune dysregulation are known to play a role in the pathogenesis of AD. In the last years, numerous studies showed that Janus kinase (JAK) enzymes have a key role in AD pathogenesis. Therefore, oral and topical JAK inhibitors are new emerging treatments for AD. We report the data relating to abrocitinib, an oral JAK1 inhibitor. For this purpose, we examined articles already published concerning, in particular, concluded clinical trials. Furthermore, we also report the design of current ongoing clinical trials. The search was carried out considering the main search engines relating to medical literature and clinical trials. From all the data we collected, abrocitinib proved to be an effective drug in significantly reducing the severity of moderate-to-severe AD when compared to placebo. Furthermore, the efficacy was similar to other well-established treatment for AD, such as dupilumab. Adverse events were generally mild; indeed, the drug was definitively suspended only in few patients.

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“… 42 , 43 A phase II randomized, double-blind, placebo-controlled trial assessed the safety and the efficacy of abrocitinib in AD patients via improvement in IGA scores, with a focus on the proportion of patients achieving IGA scores of 0 or 1 (clear or almost clear skin). 44 IGA scores of 0 or 1 were achieved by 43.8% of patients in the 200 mg abrocitinib group and by 5.8% in the placebo group at the end of 12 weeks of treatment (p<0.001). 42 Two phase III randomized, double-blind, placebo-controlled trials, JADE MONO-1 and JADE MONO-2, assessed co-primary efficacy endpoints of the percentage of patients achieving an improvement of 75% in the EASI scores (EASI-75) and IGA scores of 0 or 1 at the end of 12 weeks of treatment.…”

Section: Efficacy Of Oral Jak Inhibitors For Treatment Of Admentioning

confidence: 94%

Section: Efficacy Of Oral Jak Inhibitors For Treatment Of Ad Abrocitinibmentioning

confidence: 99%

<p>Emerging Role of Janus Kinase Inhibitors for the Treatment of Atopic Dermatitis</p>

Singh¹,

Heron²,

Ghamrawi³

et al. 2020

ITT

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Background Atopic dermatitis (AD) is a common chronic, inflammatory skin condition. The pathogenesis of AD involves many cytokines that utilize the Janus kinase/signal transducer and activator of transcription (JAK-STAT) signaling cascade; therefore, JAK inhibitors may be used in the treatment of AD. This review aims to evaluate the pathophysiology, efficacy, and safety of JAK inhibitors and their emerging role as a therapeutic option for patients with AD. Methods A PubMed search of Phase I, II, and III clinical trials was conducted for relevant literature published between January 2015 and June 2020 utilizing the key terms: JAK inhibitors, atopic dermatitis, efficacy, safety, and treatment. The search was subsequently expanded to include additional terms. Results In multiple Phase II and III clinical trials, JAK inhibitors were more efficacious than placebo or vehicle controls and slightly more efficacious in direct comparisons to corticosteroids. Overall, JAK inhibitors have a moderate safety profile for use in AD. Some of the more severe theoretical adverse events included thrombosis and reactivation of viral infections. While data remain limited for the long-term efficacy and safety of JAK inhibitor use in patients with AD, many ongoing clinical trials have promising preliminary results. Discussion Short-term data suggest that both topical and oral JAK inhibitors are efficacious and safe for use in patients with AD, although cases of thrombosis and viral disease have been reported. While the current standard treatments for AD are likely preferred, failed therapy with these agents or corticosteroid phobia may be indications for the use of JAK inhibitors in patients with AD.

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Evaluation of a Janus kinase 1 inhibitor, PF‐04965842, in healthy subjects: A phase 1, randomized, placebo‐controlled, dose‐escalation study

Abstract: These results support further evaluation of PF-04965842 for clinical use in patients with inflammatory diseases.

Cited by 41 publications

References 36 publications

TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial

TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial

The Efficacy and Safety of Abrocitinib as a Treatment Option for Atopic Dermatitis: A Short Report of the Clinical Data

<p>Emerging Role of Janus Kinase Inhibitors for the Treatment of Atopic Dermatitis</p>

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