Abrocitinib
Oral JAK1 inhibitor abrocitinib for treatment of moderate-to-severe atopic dermatitis in adults inadequately controlled by or unsuitable for topical therapy.
Source:
SwissMedic
Active Ingredients:
Indications
Representation
No sex-specific representation data
Efficacy
No sex-specific efficacy data
Posology
No sex-specific posology data
Potential Side Effects
No sex-specific potential side effect data
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
49%
51%
Clinical study participation by sex
48.9-58.6%
41.4-51.1%
Representation Gap
No sex-specific data
-0.1% to +9.6%
-9.6% to +0.1%
Sex-specific efficacy/accuracy
No sex-specific data
Efficacy in male patients was consistent with the overall study population, with no clinically meaningful sex-related differences in achievement of IGA 0/1 or EASI-75 responses versus placebo.
Efficacy in female patients was consistent with the overall study population, with no clinically meaningful sex-related differences in achievement of IGA 0/1 or EASI-75 responses versus placebo.
Sex-specific posology
No sex-specific data
The recommended adult dose is 100 mg orally once daily, taken at approximately the same time each day with or without food; tablets should be swallowed whole and may be used with or without concomitant medicated topical therapies. Treatment should not be initiated if baseline platelet count, neutrophils, lymphocytes or haemoglobin are markedly reduced, and therapy should be discontinued if there is insufficient clinical improvement after 12 weeks. Missed doses should be taken as soon as possible unless it is less than 12 hours before the next scheduled dose, and treatment should be temporarily interrupted for serious infection or significant laboratory abnormalities in line with monitoring guidance.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Pregnancy / lactation
N / A
Use is contraindicated during pregnancy and breastfeeding. There are no or limited human data, but animal studies have shown reproductive toxicity including embryo-foetal lethality, skeletal variations, dystocia and reduced postnatal survival at exposures above the clinical range; abrocitinib is excreted into rat milk, a risk to the breastfed infant cannot be excluded, and women of childbearing potential should use effective contraception during treatment and for 1 month after the final dose.
Sex-specific non-clinical findings
Nonclinical data indicate sex-specific reproductive effects: oral administration of abrocitinib caused temporary reductions in female fertility that reversed about one month after treatment cessation, while no adverse effects on male fertility or spermatogenesis were observed at high exposure multiples.
Disease prevalence by sex
Men
49%
Women
51%
Clinical study participation by sex
Men
48.9-58.6%
Women
41.4-51.1%
Representation Gap
No sex-specific data
Men
-0.1% to +9.6%
Women
-9.6% to +0.1%
Sex-specific efficacy/accuracy
No sex-specific data
Men
Efficacy in male patients was consistent with the overall study population, with no clinically meaningful sex-related differences in achievement of IGA 0/1 or EASI-75 responses versus placebo.
Women
Efficacy in female patients was consistent with the overall study population, with no clinically meaningful sex-related differences in achievement of IGA 0/1 or EASI-75 responses versus placebo.
Sex-specific posology
No sex-specific data
The recommended adult dose is 100 mg orally once daily, taken at approximately the same time each day with or without food; tablets should be swallowed whole and may be used with or without concomitant medicated topical therapies. Treatment should not be initiated if baseline platelet count, neutrophils, lymphocytes or haemoglobin are markedly reduced, and therapy should be discontinued if there is insufficient clinical improvement after 12 weeks. Missed doses should be taken as soon as possible unless it is less than 12 hours before the next scheduled dose, and treatment should be temporarily interrupted for serious infection or significant laboratory abnormalities in line with monitoring guidance.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Pregnancy / lactation
Men
N / A
Women
Use is contraindicated during pregnancy and breastfeeding. There are no or limited human data, but animal studies have shown reproductive toxicity including embryo-foetal lethality, skeletal variations, dystocia and reduced postnatal survival at exposures above the clinical range; abrocitinib is excreted into rat milk, a risk to the breastfed infant cannot be excluded, and women of childbearing potential should use effective contraception during treatment and for 1 month after the final dose.
Sex-specific non-clinical findings
Nonclinical data indicate sex-specific reproductive effects: oral administration of abrocitinib caused temporary reductions in female fertility that reversed about one month after treatment cessation, while no adverse effects on male fertility or spermatogenesis were observed at high exposure multiples.
General information
General Efficacy
Not reported
General Posology
Not reported
Further Dose Adjustments
Not reported
Possible Side Effects
The most commonly reported adverse reactions (≥2% with the 200 mg dose) in placebo‑controlled studies were nausea (15.1%; very common), headache (7.9%), acne (4.8%), herpes simplex (4.2%), increased blood creatine phosphokinase (3.8%), dizziness (3.4%) and upper abdominal pain (2.2%). Infections overall were more frequent with abrocitinib than placebo, with common events including herpes simplex, herpes zoster and pneumonia. Laboratory abnormalities included thrombocytopenia and lymphopenia, hyperlipidaemia, and creatine phosphokinase elevations; venous thrombotic events including deep vein thrombosis and pulmonary embolism were observed in the clinical trial programme only with the 200 mg dose, which is not approved in Switzerland. The most frequent serious adverse reactions were infections (0.3%), mainly herpes simplex, herpes zoster and pneumonia. Nausea led to discontinuation in about 0.4% of patients, and overall higher incidence rates of serious adverse events and treatment‑emergent adverse events leading to permanent discontinuation were reported in abrocitinib‑treated patients than in placebo recipients.
Contraindications
Not reported
Clinical Trial Type and Population
Not reported
EQUAL CARE® Evaluations
EQUAL CARE® Evaluation
Medication
Source