At the 2019 American Academy of Dermatology (AAD) conference held in early March in Washington, DC, AbbVie presented positive results on the efficacy and safety of a risankizumab over its Humira (adalimumab).
Considering the current challenges faced by AbbVie’s tumour necrosis factor (TNF) inhibitor Humira, GlobalData believes that AbbVie is seeking a strategic change in the psoriasis market. This will strengthen its portfolio and could soften the impact on sales caused by Humira biosimilars, especially in the European Union.
Psoriasis treatment: AbbeVie clinical trials
AbbVie’s Phase III clinical study, IMMvent, evaluated the efficacy and the safety of risankizumab, an interleukin (IL)-23 inhibitor, compared with Humira in patients with moderate-to-severe plaque psoriasis. A total of 605 patients were randomised in the double-blind, active comparator-controlled study. Patients were randomised 1:1 to 150mg Risankizumab (n=301, Week 0 and 4) or Humira (N=304, 80mg at Week 0, 40 mg every other week from Weeks 1–15).
At Week 16, patients who were initially randomised to risankizumab continued with the treatment (Week 16 and 28). At Week 16, patients treated with Humira who achieved a 90% reduction in Psoriasis Area and Severity Index scoring (PASI 90) response continued on Humira (Weeks 17–41); non-responders who did not achieve PASI 50 were switched to risankizumab (Week 16, 20 and 32).
Patients treated with Humira who achieved intermediate response (PASI 50–90) at Week 16 were randomised 1:1 to continue Humira (n=56; Weeks 17–41) or switch to risankizumab (n=53; Week 16, 20 and 32). The primary endpoint among re-randomised patients was PASI 90 at Week 44.
All of the trial’s primary and ranked secondary endpoints were achieved (P< 0.001). Among patients who were originally treated with Humira who achieved PASI 50–90 at Week 16, those who switched to risankizumab achieved significantly higher PASI 90 and PASI 100 at Week 44 compared with patients continuing with Humira (PASI 90, 66.0% with risankizumab versus 21.4% with Humira; PASI 100, 39.6% with risankizumab versus 7.1% with Humira; P<0.001 all comparisons).
Among Humira-treated patients who did not achieve PASI 50 who switched to risankizumab at Week 16, 60.5% achieved PASI 90 and 36.8% achieved PASI 100 at Week 44. In patients who were initially randomised to and continued on risankizumab, PASI 90 and PASI 100 at Week 44 were 75.7% and 52.8%.
The rates of treatment-emergent adverse events (TEAEs) leading to discontinuation were generally low, and the frequency of TEAEs was comparable between patients continuing on Humira and patients switching from Humira to risankizumab. A similar safety profile was observed between patients continuing risankizumab and patients switching directly from Humira to risankizumab.
In line with these positive results, AbbVie has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for risankizumab based on results from four Phase III clinical studies: IMMvent, IMMhance, ultIMMA-1, and ultIMMa-2.
Compensating for impact of Humira biosimilars
All four trials met their co-primary and ranked secondary endpoints, achieving a significantly higher response of clear or almost clear skin (Static Physicians Global Assessment [sPGA] 0/1 and PASI 90) compared to ustekinumab, Humira, and placebo at Week 16 and up to Week 52.
Overall, GlobalData believes that AbbVie’s strategy is shifting to compensate for the impact of Humira biosimilars. Strong results demonstrating efficacy and safety in all four trials show that risankizumab will be a strong contender in the psoriasis market.
Furthermore, in GlobalData’s Plaque Psoriasis: Global Drug Forecast and Market Analysis to 2027 report, it is anticipated that risankizumab will generate sales of $899.5 million by 2027.