December 2021
IQWIG says Rinvoq has added benefit at higher doses, but with safety issues
IQWIG has assessed the benefit assessment of Rinvoq (upadacitinib) in patients with atopic dermatitis. Rinvoq is approved for treating adults and adolescents with atopic dermatitis candidates for systemic therapy. It is approved under two different strengths, 15 mg, and 30 mg.
IQWIG considered dupilumab as appropriate comparator therapy. The German institute considered that Rinvoq has a major added benefit in men and considerable added benefit in females at higher doses. However, the added benefit was not proven in adolescents and lower doses.
AbbVie has presented a head-to-head trial versus dupilumab, 24 week time period was considered. The study has considered high doses of Rinvoq; IQWIG was satisfied with it as lower doses are assumed to be indicated for less severe cases. Further, the study included severe patients who were treated with prior systemic therapy. Rinvoq has shown positive and negative symptoms versus dupilumab - there was relief in symptoms but with adverse events. Adverse events are more severe in women resulted in the 'considerable' added benefit. In men, there was a major added benefit.
G-BA will make the final decision on the added benefits.
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