Abrocitinib

(Cibinqo®)

Abrocitinib

Drug updated on 9/4/2024

Dosage FormTablet (oral: 50 mg, 100 mg, 200 mg)
Drug ClassJanus kinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For the treatment of adults with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

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Summary
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  • Ztalmy (ganaxolone) is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.
  • This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
  • Eczema Area and Severity Index (EASI) Outcomes: High-dose upadacitinib (30 mg) demonstrates the highest efficacy in achieving EASI-75, EASI-90, and EASI-50 across multiple studies. Abrocitinib (200 mg) is effective but generally less so than high-dose upadacitinib, while Dupilumab, lebrikizumab, and tralokinumab show intermediate effectiveness.
  • Investigator Global Assessment (IGA) Outcomes: Upadacitinib (30 mg) is most effective in achieving IGA 0/1 responses, with abrocitinib (200 mg) showing significant but slightly lower efficacy. Dupilumab provides moderate results, outperforming baricitinib and tralokinumab.
  • Pruritus Numerical Rating Scale (NRS) Outcomes: Upadacitinib (30 mg) leads to the highest improvement in pruritus scores, followed by abrocitinib (200 mg), which outperforms lower doses and other JAK inhibitors.
  • Quality of Life Outcomes: Abrocitinib, particularly at the 200 mg dose, significantly improves Dermatology Life Quality Index (DLQI) and Patient Oriented Eczema Measure (POEM) scores.
  • High-dose JAK inhibitors, such as upadacitinib (30 mg) and abrocitinib (200 mg), are associated with an increased risk of adverse events (AEs), including headache, acne, elevated blood creatinine phosphokinase, and nausea. Severe adverse events occur more frequently with high-dose JAK inhibitors compared to dupilumab.
  • The risk of serious adverse events (SAEs), such as serious infections, non-melanoma skin cancer, major adverse cardiovascular events, and venous thromboembolism, is not significantly increased with JAK inhibitors in short-term studies.
  • Both abrocitinib (200 mg) and upadacitinib (30 mg) have higher rates of treatment-emergent adverse events (TEAEs) compared to placebo, with higher incidences observed for these doses relative to lower doses and other JAK inhibitors.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Cibinqo (abrocitinib) Prescribing Information.2022Pfizer Labs, New York, NY

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Systemic treatments for atopic dermatitis (eczema): Systematic review and network meta-analysis of randomized trials. 2023The Journal of Allergy and Clinical Immunology
Oral Janus kinase inhibitors in the treatment of atopic dermatitis: A systematic review and meta‐analysis.2023Skin Health and Disease
Efficacy and safety of abrocitinib and upadacitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A systematic review and meta-analysis.2023Heliyon
Comparing binary efficacy outcomes for systemic immunomodulatory treatments for atopic dermatitis in a living systematic review and network meta-analysis. 2023British Journal of Dermatology
The safety of systemic Janus kinase inhibitors in atopic dermatitis: A systematic review and meta-analysis of randomized controlled trials. 2023Journal of the European Academy of Dermatology & Venerelogy
Comparative efficacy and safety of abrocitinib, baricitinib, and upadacitinib for moderate‐to‐severe atopic dermatitis: A network meta‐analysis. 2022Dermatologic Therapy
Comparative efficacy of targeted systemic therapies for moderate to severe atopic dermatitis without topical corticosteroids: Systematic review and network meta-analysis.2022Dermatology and Therapy
Systemic immunomodulatory treatments for atopic dermatitis: Update of a living systematic review and network meta-analysis.2022JAMA Dermatology
Efficacy and safety of abrocitinib for the treatment of moderate-to-severe atopic dermatitis: A meta-analysis of randomized clinical trials.2022Journal of Demagogical Treatment
Efficacy of biologics and oral small molecules for atopic dermatitis: A systematic review and meta-analysis.2022Journal of Demagogical Treatment
Biological therapies for atopic dermatitis: A systematic review.2021Dermatology
Effectiveness and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis: A systematic review and meta-analysis of randomized clinical trials.2021Dermatology Research and Practice
Comparative efficacy and safety of systemic therapies used in moderate-to-severe atopic dermatitis: A systematic literature review and network meta-analysis.2021Journal of the European Academy of Dermatology and Venereology
Systematic review on the efficacy and safety of oral Janus kinase inhibitors for the treatment of atopic dermatitis.2021Frontiers in Medicine
Short-term effectiveness and safety of biologics and small molecule drugs for moderate to severe atopic dermatitis: A systematic review and network meta-analysis.2021Life
Efficacy and safety of Janus kinase inhibitors for the treatment of atopic dermatitis: A systematic review and meta-analysis.2021Dermatology
Comparing quality of life outcomes of JAK inhibitors and biological treatments for atopic dermatitis: A systematic review and network meta-analysis.2021Expert Review of Clinical Pharmacology

Clinical Practice Guidelines

Document TitleYearSource
Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies.2024Journal of the American Academy of Dermatology