AbbVie aims to advance its immunology pipeline by initiating a global Phase 3 trial of Rinvoq (upadacitinib) for Hidradenitis Suppurativa (HS) treatment. AbbVie’s Humira is already approved for HS and its biosimilars are available across major markets.
HS is a challenging chronic inflammatory condition with limited therapeutic options. The study is aimed to evaluate the efficacy and safety of Rinvoq in adults and adolescents with moderate to severe HS who have not responded to anti-tumour necrosis factor (TNF) therapy and/or one approved non-anti-TNF inhibitor therapy for HS.
HS manifests as painful bumps, nodules, or abscesses on the skin that can cause scarring and form tunnels underneath the skin. It typically occurs in areas where hair grows or where skin rubs against skin. Despite potentially affecting up to one per cent of the global population, HS often remains undiagnosed for seven to ten years, with limited treatment options.
The Step-Up HS study is the first Phase 3 trial, aiming to enrol around 1,300 participants worldwide. It will be a randomised, placebo-controlled, double-masked, trial aimed to assess the efficacy of Rinvoq compared to a placebo in adults and adolescents with moderate to severe HS who haven’t responded to previous treatments. The study will have three periods, evaluating the safety and efficacy of Rinvoq versus placebo.
The primary endpoint of the study is to evaluate the percentage of participants achieving HS clinical response (HiSCR) 50. This refers to a reduction of at least 50 percent in the total count of abscesses and inflammatory nodules (AN), with no raise in abscess count, and draining fistula measure compared to the baseline at week 16.
AbbVie has presented the Phase 2 data of Rinvoq at AAD conference. The primary endpoint is a >50% reduction in HiSCR count at week 12. 38.3% of patients achieved the primary endpoint versus 23.8% of patients on placebo, a difference of nearly 15%. The efficacy in TNF-naive patients was similar to that observed in TNF- inadequate response patients.
In the Phase 2 trial, the safety profile was consistent with Rinvoq’s established profile.
Novartis presented the long-term data of SUNSHINE and SUNRISE trials, demonstrating the efficacy and symptom improvement in moderate-to-severe hidradenitis suppurativa patients.
Over 55% of patients achieved HS Clinical Response (HiSCR) at Week 52, and 60% were free of flares. Over 50% of patients had reduced pain, a burdensome symptom in HS patients.
No new safety signals were observed in the HS trials. Novartis announced that it submitted the data to Europe and United States regulatory agencies. Cosentyx, if approved, will be the first interleukin-17 inhibitor that would be approved for moderate-to-severe HS.