Rinvoq exhibits ‘acceptable benefit and risk profile’ for AD treatment up to 140 weeks
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Key takeaways:
- EASI 75 and validated IGA-AD 0/1 response rates from week 16 were maintained through week 140.
- No new safety signals for Rinvoq were observed.
Rinvoq showed long-term efficacy and safety up to 140 weeks in the treatment of moderate to severe atopic dermatitis in adults and adolescents aged 12 years and older, AbbVie announced in a press release.
The results of three phase 3 studies — Measure Up 1, Measure Up 2 and AD Up — investigating the efficacy and safety of Rinvoq (upadacitinib) as AD treatment were presented at the European Academy of Dermatology and Venereology 2023 Congress.
“While upadacitinib is currently approved for seven indications, including atopic dermatitis, it is also being studied in other immune-mediated diseases,” Jonathan Silverberg, MD, PhD, MPH, lead study investigator and director of clinical research at George Washington University School of Medicine and Health Science, told Healio.
AbbVie recently announced new long-term results for Rinvoq from data-analyses of
Patients in the three included studies were randomly assigned to receive Rinvoq 15 mg or 30 mg or placebo, whereas treatment in AD Up was also in combination with topical corticosteroids.
Efficacy results showed that a significantly higher proportion of patients treated with Rinvoq vs. placebo achieved the co-primary endpoints of improvement in skin clearance according to EASI and validated IGA-AD scores by week 16 and maintained these scores through week 140.
In Measure Up 1, 88.8% of patients treated with 15 mg and 90.3% treated with 30 mg achieved EASI 75 and 63.4% and 65.5% achieved validated IGA-AD 0/1, respectively, by week 140.
Similar improvements in EASI 75 and validated IGA-AD 0/1 were seen in Measure Up 2 in the 15 mg group (82% and 49.2%) and 30 mg group (90.7% and 63.2%) by week 140.
The results from AD Up also proved long-term consistency in Rinvoq’s performance, with 81.5% and 52% of the 15 mg group and 90% and 56.8% of 30 mg group reaching EASI 75 and validated IGA-AD 0/1, respectively.
According to the press release, safety data also showed that Rinvoq was “generally well-tolerated” up to 140 weeks, with safety data consistent with the drug’s known safety profile. The most common adverse events included COVID-19, upper respiratory tract infection, acne and nasopharyngitis.
This demonstrates that when taken continuously for a long period of time, upadacitinib has “an acceptable benefit and risk profile” for the treatment of AD, according to the press release.
Concerning next steps for Rinvoq, Silverberg said that “studies are underway to better understand the comparative efficacy of different dosing strategies for Rinvoq in AD.”