[8] The most common side effects include nausea (feeling sick), headache, acne, herpes simplex (viral infection of the mouth or the genitals), increased levels of creatine phosphokinase in the blood (an enzyme released into the blood when muscle is damaged), vomiting, dizziness and pain in the upper belly.
[10][11] In the EU, abrocitinib is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.
[9] In the US, abrocitinib is indicated for the treatment of people twelve years of age and older 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.
[13] In another meta-analysis including 2256 patients from three different studies have showed that abrocitinib improved the EASI scores in comparison with dupilumab, even in the second week of treatment.
[12] In other studies, abrocitinib (200 mg dose) achieved rapid relief from itching after four days of treatment compared with dupilumab and placebo in AD patients.
[14] The most common adverse effects in studies were upper respiratory tract infection, headache, nausea, and diarrhea.
[11] Abrocitinib can cause serious infections, malignancy, major cardiac events, thrombosis and other laboratory abnormalities including thrombocytopenia, lymphopenia, and lipid elevations.
[13] Symptoms such as acne, headache, and nausea, appeared in the first two weeks of starting abrocitinib, and it was not necessary to interrupt the treatment.
[17][18] Abrocitinib is quickly absorbed from the gut and generally reaches highest blood plasma concentrations within one hour.
[17][18] The US Food and Drug Administration (FDA) approved abrocitinib based on evidence from three controlled clinical trials enrolling a total of 1615 participants supporting efficacy and safety.
[11] The trials were conducted at multiple sites in 18 countries (i.e., United States, Canada, Australia, Mexico, Chile, Great Britain, Poland, Germany, Bulgaria, Hungary, Czech Republic, Latvia, Slovakia, Spain, Italy, Japan, Korea, Taiwan).
[11] Trial-AD-3 with concomitant background therapy was a 24-week, multicenter, randomized, double-blind, active-comparator (dupilumab) and placebo-controlled, phase 3 trial.
[9][24][25] In January 2022, the US Food and Drug Administration (FDA) approved abrocitinib for adults with moderate-to-severe atopic dermatitis.
Abrocitinib may play the role of an immune modulator in oral immunotherapy of peanut or may be administered alone as monotherapy in cases of allergy to certain food.
A constant improvement of lesions, a depletion of Wickham striae, and a disappearance of erosions were observed at weeks four and eight of treatment.