Abrocitinib

Pfizer AG

Inhibition of the selective activation of JAK1; blockade of the intracellular signalling cascade of the JAK-STAT signalling pathway, resulting in a reduction in the inflammatory response.

Moderate to severe atopic dermatitis, authorised for use in people aged 18 and over.

Yes

Patients aged 18 years and over with severe atopic dermatitis (IGA 4 or SCORAD > 50 or EASI ≥ 21.1), provided that the patients have responded inadequately to intensified local treatment with topical corticosteroids and/or calcineurin inhibitors and phototherapy (where available and indicated) and to systemic treatment with a conventional immunosuppressant (excluding systemic corticosteroids) for at least one month. No reimbursement in combination with other systemic medicinal products. Discontinuation of treatment is indicated if there is a lack of therapeutic response (no reduction in IGA score by ≥ 2 points / ≥50% improvement in EASI 50 / ≥50% improvement in SCORAD 50) after 12 weeks.

50 mg and 100 mg film-coated tablets.

Complete blood count, liver enzymes, lipid profile, creatinine, CRP, pregnancy test, urinalysis, screening for HBV, HCV, HIV and TB (optional: including chest X-ray), update of vaccination status (including varicella/herpes zoster vaccination).

Complete blood count (CBC), CRP, transaminases, creatinine, β-hCG; lipid levels.

Month 1, 2, then every 3 months; lipid levels: month 2, then every 6 months.

The recommended dose of Cibinqo is 100 mg once daily. In patients with a platelet count <150 × 10³/mm³, an absolute lymphocyte count (ALC) <0.5 × 10³/mm³, an absolute neutrophil count (ANC) <1 × 10³/mm³ or a haemoglobin level <8 g/dL, treatment with Cibinqo should not be initiated.

At week 12 or week 16, both primary endpoints: IGA 0 or 1 and/or EASI 75.

Patients aged >65 years, with current or previous nicotine use, current or a history of malignant diseases; live vaccines must not be administered immediately before or during treatment. No data are available for patients with atopic dermatitis with a baseline creatinine clearance of less than 40 mL/min.
Caution is advised in cases of known diverticular disease (particularly when taking concomitant medication such as NSAIDs, corticosteroids, opioids and other medicines associated with an increased risk of diverticulitis) and in the presence of risk factors for deep vein thrombosis and pulmonary embolism.

14,619 CHF

If a patient develops a severe infection, sepsis or an opportunistic infection, consideration should be given to suspending treatment with Cibinqo until the infection has resolved.

If a patient develops a severe infection, sepsis or an opportunistic infection, consideration should be given to suspending treatment with Cibinqo until the infection has resolved.

Not described

Hypersensitivity to the relevant JAK inhibitor or to excipients; severe progressive or opportunistic infection; severe hepatic impairment (Child-Pugh class C); neutropenia < 1 x 10⁹/L (= 1 G/L); anaemia < 80 g/L, hormonal contraception or hormone replacement therapy, pregnancy and breastfeeding, severe renal impairment (GFR < 30 mL/min), heart failure, previous venous thromboembolism, congenital coagulation disorder, patients with malignancies, major surgery, active severe systemic infections.

Nausea (15.1 %), headaches (7.9 %), acne (4.8 %), herpes simplex (4.2 %), elevated creatine phosphokinase levels in the blood (3.8 %), dizziness (3.4 %) and upper abdominal pain (2.2 %), infections (e.g. nasopharyngitis, urinary tract infection, bronchitis, sinusitis, etc.), herpes zoster, anaemia, leukopenia, hyperlipidaemia, weight gain, insomnia, hypertension, diarrhoea, lower abdominal pain, rash, arthralgia, musculoskeletal pain, elevated liver enzymes, peripheral oedema, fever, fatigue, thrombosis/embolism.

Insufficient data

Ketoconazole, fluconazole, cyclosporine, rifampicin, chloroquine, probenecid. No interactions with MTX or biologics have been reported (however, their use is not recommended).

Requires treatment with isoniazid and vitamin B6 for 9 months; treatment with biologics may be started after 1 month. Alternatively, rifampicin for 4 months.

Increased risk of malignant diseases, in particular bronchial carcinomas, NMSCs and lymphomas.