Effectiveness and safety of baricitinib in patients with alopecia areata: a systematic review and Meta-analysis of randomized controlled trials

Mahmoud, Abdelrahman Mohamed

doi:10.1080/03007995.2022.2135838

Cited by 8 publications

(12 citation statements)

References 30 publications

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“…An increased risk of thromboembolic events has been suggested based on study data from individual JAKi 1,9,10 . The actual, individual risk of thromboembolic events during JAKi treatment in dermatological indications is still very low 11,12 . The new safety assessment mainly concerns an increase in the general risk by coincident, independent risk factors for venous thromboembolism 3 .…”

Section: Risk Of Venous Thromboembolic Eventsmentioning

confidence: 99%

“…1,9,10 The actual, individual risk of thromboembolic events during JAKi treatment in dermatological indications is still very low. 11,12 The new safety assessment mainly concerns an increase in the general risk by coincident, independent risk factors for venous thromboembolism. 3 A relative contraindication for the use of JAKi would therefore apply primarily in cases of hereditary thrombophilia (such as APC resistance in Factor V Leiden mutation, hyperhomocysteinemia with polymorphism, prothrombin mutation, increased Factor VIII activity, and more rarely protein C deficiency, protein S deficiency, or antithrombin deficiency) as well as acquired thrombophilia (such as primary or secondary antiphospholipid syndrome, or severe liver dysfunction).…”

Section: Risk Of Venous Thromboembolic Eventsmentioning

confidence: 99%

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Recommendations for risk minimization when using Janus kinase inhibitors for the treatment of chronic inflammatory skin diseases

Wohlrab

Kegel

Große

et al. 2023

J Deutsche Derma Gesell

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SummaryIn accordance with article 20 of Regulation (EC) No 726/2004, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has re‐evaluated the safety of Janus kinase inhibitors for the treatment of inflammatory diseases and formulated safety information deviating from the previous indications in the respective summary of product characteristics of the products concerned. These refer to the consideration of a possibly increased risk of venous thromboembolic or severe cardiovascular events, an increased infection rate and an increase in the prevalence of skin cancer across drugs and indications. Therefore, in patients with independent risk factors (age 65 years and older, smokers or former smokers, patients with oral contraception or hormone replacement therapy and other risk factors), it is recommended to use Janus kinase inhibitors therapeutically only if there are no suitable treatment alternatives. To facilitate a pragmatic and thorough detection of high‐risk patients in everyday clinical practice, an interdisciplinary checklist was developed that is suitable as a working tool from the perspective of the dermatologist.

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Section: Risk Of Venous Thromboembolic Eventsmentioning

confidence: 99%

Section: Risk Of Venous Thromboembolic Eventsmentioning

confidence: 99%

Recommendations for risk minimization when using Janus kinase inhibitors for the treatment of chronic inflammatory skin diseases

Wohlrab

Kegel

Große

et al. 2023

J Deutsche Derma Gesell

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“…It used as an antiarrhythmic agent, and JAK inhibitor with proven and effective anti-inflammatory and anti-viral effects, used during Covid-19 as a immunomodulatory, 9,10 recently it got approved for treatment of alopecia. 11,12 BAR is the first FDA-approved once-daily pill for the treatment of severe alopecia areata, this International Journal of Nanomedicine 2023:18 2239-2251 JAK inhibitor demonstrated excellent hair regrowth compared to the placebo. 13 Moreover, it was also shown to decrease the proliferation of JAK1/JAK2 expression in mutated cells and causes caspase-mediated cell death.…”

Section: Introductionmentioning

confidence: 99%

Development of Diphenyl carbonate-Crosslinked Cyclodextrin Based Nanosponges for Oral Delivery of Baricitinib: Formulation, Characterization and Pharmacokinetic Studies

Aldawsari¹,

Alhowail²,

Anwer³

et al. 2023

IJN

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Background:The aim of the present investigation is to prepare baricitinib (BAR)-loaded diphenyl carbonate (DPC) β-cyclodextrin (βCD) based nanosponges (NSs) to improve the oral bioavailability. Methods: BAR-loaded DPC-crosslinked βCD NSs (B-DCNs) were prepared prepared by varying the molar ratio of βCD: DPC (1:1.5 to 1:6). The developed B-DCNs loaded with BAR were characterized for particle size, polydispersity index (PDI), zeta potential (ZP), % yield and percent entrapment efficiency (%EE). Results: Based on the above evaluations, BAR-loaded DPC βCD NSs (B-CDN3) was optimized with mean size (345.8±4.7 nm), PDI (0.335±0.005), Yield (91.46±7.4%) and EE (79.1±1.6%). The optimized NSs (B-CDN3) was further confirmed by SEM, spectral analysis, BET analysis, in vitro release and pharmacokinetic studies. The optimized NSs (B-CDN3) showed 2.13 times enhancement in bioavailability in comparison to pure BAR suspension. Conclusion: It could be anticipated that NSs loaded with BAR as a promising tool for release and bioavailability for the treatment of rheumatic arthritis and Covid-19.

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“…The Janus kinase signal transducer and activator of transcription (JAK-STAT) is a key inflammatory pathway in a number of dermatologic, hematologic, and rheumatologic conditions, and JAK inhibitors are an emerging treatment option for these disorders . There are 4 recognized JAK proteins—JAK1, JAK2, JAK3, and tryosine kinase 2 (TYK2)—and 8 medications approved by the US Food and Drug Administration that inhibit this pathway.…”

Section: Introductionmentioning

confidence: 99%

“…he Janus kinase signal transducer and activator of transcription (JAK-STAT) is a key inflammatory pathway in a number of dermatologic, hematologic, and rheumatologic conditions, [1][2][3][4][5] and JAK inhibitors are an emerging treatment option for these disorders. [6][7][8][9][10][11][12][13] There are 4 recognized JAK proteins-JAK1, JAK2, JAK3, and tryosine kinase 2 (TYK2)and 8 medications approved by the US Food and Drug Administration that inhibit this pathway. Baricitinib and ruxolitinib phosphate target JAK1 and JAK2; fedratinib hydrochloride and pacritinib citrate target JAK2; tofacitinib citrate targets JAK1, JAK2, and JAK3; upadacitinib and abrocitinib target only JAK1; and deucravacitinib targets TYK2.…”

mentioning

confidence: 99%

Janus Kinase Inhibitors and Adverse Events of Acne

Martinez,

Manjaly,

Manjaly

et al. 2023

JAMA Dermatol

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ImportanceJanus kinase (JAK) inhibitors are increasingly used across a range of dermatologic conditions. Adverse events of acne have been noted in some studies in clinical practice, but the scope of this outcome across JAK inhibitors has not been established.ObjectiveTo systematically analyze all published phase 2 and 3 placebo-controlled randomized clinical trials (RCTs) of JAK inhibitors for the risk of acne as an adverse effect of these medications.Data SourcesComprehensive search of Ovid MEDLINE and PubMed databases through January 31, 2023.Study SelectionInclusion criteria were phase 2 and 3 placebo-controlled RCTs of JAK inhibitors published in English with reported adverse events of acne.Data Extraction and SynthesisTwo reviewers independently reviewed and extracted information from all included studies.Main Outcomes and MeasuresThe primary outcome of interest was the incidence of acne following JAK inhibitor use. A meta-analysis was conducted using random-effects models.ResultsA total of 25 unique studies (10 839 unique participants; 54% male and 46% female) were included in the final analysis. The pooled odds ratio (OR) was calculated to be 3.83 (95% CI, 2.76-5.32) with increased ORs for abrocitinib (13.47 [95% CI, 3.25-55.91]), baricitinib (4.96 [95% CI, 2.52-9.78]), upadacitinib (4.79 [95% CI, 3.61-6.37]), deucravacitinib (2.64 [95% CI, 1.44-4.86]), and deuruxolitinib (3.30 [95% CI, 1.22-8.93]). Estimated ORs were higher across studies investigating the use of JAK inhibitors for the management of dermatologic compared with nondermatologic conditions (4.67 [95% CI, 3.10-7.05]) as well as for JAK1-specific inhibitors (4.69 [95% CI, 3.56-6.18]), combined JAK1 and JAK2 inhibitors (3.43 [95% CI, 2.14-5.49]), and tyrosine kinase 2 inhibitors (2.64 [95% CI, 1.44-4.86]).Conclusions and RelevanceIn this systematic review and meta-analysis, JAK inhibitor use was associated with an elevated odds of acne. Patients should be properly counseled on this potential adverse effect of these medications before treatment initiation. Future studies are needed to further elucidate the pathophysiology of this association.

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Effectiveness and safety of baricitinib in patients with alopecia areata: a systematic review and Meta-analysis of randomized controlled trials

Cited by 8 publications

References 30 publications

Recommendations for risk minimization when using Janus kinase inhibitors for the treatment of chronic inflammatory skin diseases

Recommendations for risk minimization when using Janus kinase inhibitors for the treatment of chronic inflammatory skin diseases

Development of Diphenyl carbonate-Crosslinked Cyclodextrin Based Nanosponges for Oral Delivery of Baricitinib: Formulation, Characterization and Pharmacokinetic Studies

Janus Kinase Inhibitors and Adverse Events of Acne

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