The US Food and Drug Administration. approved Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in patients 12 years of age and older, the manufacturer announced Friday.
Rinvoq 15 mg dose may be initiated in patients 12 years of age and older
The approval is indicated for patients with atopic dermatitis who did not respond to previous treatment and are not well controlled with other medications or when the use of other medications is not recommended. A 15-mg dose of Rinvoq can be started in patients 12 years of age and older who weigh at least 40 kg (88 lb); in those under 65 years of age who do not achieve an adequate response to this dose, the dose may be increased to 30 mg once daily.
The approval was based on efficacy and safety data from more than 2,500 patients in three studies. Approximately 52 percent of these patients had been previously exposed to treatment for systemic atopic dermatitis.
RESULTS OF YOUR APPROVAL
In all three studies at 16 weeks, patients receiving Rinvoq once daily (15 mg and 30 mg) monotherapy and in combination with topical corticosteroids achieved the primary endpoints of at least a 75% reduction in the index eczema area and severity index and an investigator-validated eczema area and severity index. Global assessment for atopic dermatitis of clear or almost clear (0/1) with at least two grade reduction from baseline. A significant improvement in numerical rating scale of worst pruritus ≥4 was observed as early as the first week of treatment with Rinvoq compared to placebo.
The safety profile of Rinvoq in patients with atopic dermatitis was similar to that observed in patients with rheumatoid arthritis. Other adverse reactions specific to patients with atopic dermatitis included eczema herpeticum/Kaposi’s varicelliform eruption. Serious side effects of Rinvoq include infections such as tuberculosis, an increased risk of death in people over age 50 who have at least one cardiovascular risk factor, an increased risk of certain types of cancer, and blood clots.
Approval was granted to AbbVie.
Atopic dermatitis in Mexico
According to the World Health Organization, by 2050, half of the population will suffer from allergies. Allergic diseases develop after an inflammation known as type 2 occurs in the body. Atopic dermatitis is an immunoallergic disease that is caused by this type of inflammation.
Patients with this condition may present signs on their skin such as: dryness, cracking, redness, bleeding and scabs, in addition to the main symptom, which is associated with the great burden of the disease, is itching. It is estimated that in Mexico there are at least 12 million people who suffer from atopic dermatitis and it is known that up to 75% of severe cases present at least one allergic comorbidity: 60% rhinitis, 40% asthma, 30% food allergy and 13% nasal polyposis.
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