Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo

Rosmarin, David; Passeron, Thierry; Pandya, Amit G.; Grimes, Pearl E.; Harris, John E.; Desai, Seemal R.; Lebwohl, Mark; Ruer‐Mulard, M.; Sénéschal, Julien; Wolkerstorfer, Albert; Kornacki, Deanna; Sun, Kang; Butler, Kathleen; Ezzedine, Khaled

doi:10.1056/nejmoa2118828

Cited by 114 publications

(112 citation statements)

References 35 publications

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“…Ruxolitinib is the first topical formulation approved for repigmentation in vitiligo patients. The FDA has approved ruxolitinib cream (1.5%) for treating non-segmental vitiligo in adult and pediatric patients 12 years and older ( Rosmarin et al, 2022 ).…”

Section: Jakinibs and Covid-19mentioning

confidence: 99%

Therapeutic implications of current Janus kinase inhibitors as anti-COVID agents: A review

et al. 2023

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Severe cases of COVID-19 are characterized by hyperinflammation induced by cytokine storm, ARDS leading to multiorgan failure and death. JAK-STAT signaling has been implicated in immunopathogenesis of COVID-19 infection under different stages such as viral entry, escaping innate immunity, replication, and subsequent inflammatory processes. Prompted by this fact and prior utilization as an immunomodulatory agent for several autoimmune, allergic, and inflammatory conditions, Jakinibs have been recognized as validated small molecules targeting the rapid release of proinflammatory cytokines, primarily IL-6, and GM-CSF. Various clinical trials are under investigation to evaluate Jakinibs as potential candidates for treating COVID-19. Till date, there is only one small molecule Jakinib known as baricitinib has received FDA-approval as a standalone immunomodulatory agent in treating critical COVID-19 patients. Though various meta-analyses have confirmed and validated the safety and efficacy of Jakinibs, further studies are required to understand the elaborated pathogenesis of COVID-19, duration of Jakinib treatment, and assess the combination therapeutic strategies. In this review, we highlighted JAK-STAT signalling in the pathogenesis of COVID-19 and clinically approved Jakinibs. Moreover, this review described substantially the promising use of Jakinibs and discussed their limitations in the context of COVID-19 therapy. Hence, this review article provides a concise, yet significant insight into the therapeutic implications of Jakinibs as potential anti-COVID agents which opens up a new horizon in the treatment of COVID-19, effectively.

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Section: Jakinibs and Covid-19mentioning

confidence: 99%

Therapeutic implications of current Janus kinase inhibitors as anti-COVID agents: A review

et al. 2023

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“…Trials reported a consistent incidence of 0.3% (1/311, 1/326) in ruxolitinib-treated patients compared with 0/109 in placebo, with one patient developing myocarditis and another developing coronary artery stenosis, both of which were deemed unrelated to treatment [ 53 ].…”

Section: Methodsmentioning

confidence: 99%

“…Nasopharyngitis occurred in 9/221 (4.1%) and 10/228 (4.4%) in ruxolitinib-treated patients compared with 4/109 (3.7%) and 1/115 (0.9%) in placebo [ 53 ].…”

Section: Common Adverse Effects Of Jak Inhibitorsmentioning

confidence: 99%

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A Review on the Safety of Using JAK Inhibitors in Dermatology: Clinical and Laboratory Monitoring

Samuel

Cornman

Kambala

et al. 2023

Dermatol Ther (Heidelb)

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Janus kinase (JAK) inhibitors are disease-modifying agents with efficacy in treating a spectrum of burdensome dermatologic conditions. The US Food and Drug Administration (FDA) recently placed a black box warning on this class of medications due to safety concerns based on data from studies investigating tofacitinib in patients with rheumatoid arthritis. Here we provide an overview of the timeline of FDA approval of JAK inhibitors in dermatology. We also discuss the available safety profiles of approved oral JAK1 inhibitors, namely abrocitinib and upadacitinib, oral baricitinib, a JAK1/2 inhibitor, deucravacitinib, a Tyk2 inhibitor, and the topical JAK1/2 inhibitor ruxolitinib in dermatology patients. Additionally, we offer suggestions for initial screening and laboratory monitoring for patients receiving JAK inhibitors. We found that the rates of venous thromboembolism reported in trials ranged from no events to 0.1–0.5% in dermatology-specific phase 3 clinical trials compared with no events in the placebo. The rates of cardiovascular events ranged from no events to 0.4–1.2% compared with no events to 0.5–1.2% in the placebo. The rates of serious infections were 0.4–4.8% compared with no events to 0.5–1.3% in the placebo. The rates of nonmelanoma skin cancer (NMSC) ranged from no event to 0.6–0.9% compared with no events in the placebo. The rates of non-NMSC ranged from no event to 0.2–0.7% compared with no event to 0.6% in the placebo. Most patients who developed these adverse events had risk factors for the specific event. The most common adverse events of oral JAK inhibitors included upper respiratory infections, nasopharyngitis, nausea, headache, and acne. Dermatologists should consider patients’ baseline risk factors for developing serious complications when prescribing oral JAK inhibitors.

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“…Its oral form has been approved by the US Food and Drug Administration (FDA) for polycythemia vera, myelofibrosis, and graft-vs-host disease, while ruxolitinib, 1.5%, cream is FDA approved for atopic dermatitis and vitiligo. 3,4 The broad association of JAK inhibition with cytokine signaling suggests that ruxolitinib may be useful in treating various inflammatory or autoimmune conditions. In this article, we present a case of rapid response of severe, recalcitrant LMDF with ruxolitinib, 1.5%, cream.…”

mentioning

confidence: 99%

Response of Severe Lupus Miliaris Disseminatus Faciei to Treatment With Ruxolitinib Cream

Gorham

Jacobs

2023

JAMA Dermatol

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Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo

Cited by 114 publications

References 35 publications

Therapeutic implications of current Janus kinase inhibitors as anti-COVID agents: A review

Therapeutic implications of current Janus kinase inhibitors as anti-COVID agents: A review

A Review on the Safety of Using JAK Inhibitors in Dermatology: Clinical and Laboratory Monitoring

Response of Severe Lupus Miliaris Disseminatus Faciei to Treatment With Ruxolitinib Cream

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