AbbVie’s Skyrizi Demonstrates Durable Long-Term Efficacy in Plaque Psoriasis, Reinforcing Its Role in the Post-Humira Era

June 12, 2019 News /BioValleyBIOON/ -- AbbVie, the U.S. biotechnology giant, recently announced long-term (2-year) data from the Phase III IMMhance study (NCT02672852) evaluating its novel anti-inflammatory drug Skyrizi (risankizumab) for the treatment of plaque psoriasis at the 24th World Congress of Dermatology (WCD) held in Milan, Italy. The results showed that among patients who achieved sPGA 0/1 clearance at Week 28 and continued Skyrizi treatment, a substantially high proportion experienced complete clearance of skin plaques (defined as sPGA 0 and PASI 100) by Week 94: 73% and 72% of patients achieved sPGA 0 and PASI 100, respectively. No new safety signals were identified over the 2-year (104-week) study period.

IMMhance is an ongoing, multicenter, randomized, double-blind, placebo-controlled Phase III study conducted by AbbVie in collaboration with Boehringer Ingelheim, designed to evaluate the efficacy and safety of Skyrizi versus placebo in patients with moderate-to-severe plaque psoriasis. The study consists of two stages. In Stage 1, patients were randomized in a 4:1 ratio to receive either Skyrizi (n=407; 150 mg administered at baseline, Week 4, and every 12 weeks thereafter) or placebo (n=100). In Stage 2 (Weeks 28–104), patients initially randomized to Skyrizi who achieved an sPGA score of 0/1 (clear or almost clear) were re-randomized to either continue Skyrizi (maintenance group, n=111; dosed every 12 weeks, with the last dose administered at Week 88) or switch to placebo (withdrawal group, n=225). Safety was assessed in all patients, with follow-up continuing through Week 104.

Previously announced Phase 1 results showed that after 16 weeks of treatment, the Skyrizi group achieved the co-primary endpoints of PASI 90 and sPGA 0/1 compared to the placebo group (p<0.001). Phase 2 results demonstrated that the primary endpoint of sPGA 0/1 was also achieved at Week 52 (one year) of treatment.

The newly released data show that: (1) The proportion of patients in the Skyrizi maintenance group achieving complete clearance of skin plaques continued to increase from Week 52 to Week 94. The sPGA 0 and PASI 100 response rates were 65% and 64%, respectively, at Week 52, increasing to 73% and 72% at Week 94 (p<0.001). (2) At Week 104 (2 years), patients in the Skyrizi maintenance group maintained complete or almost complete clearance of skin plaques, with sPGA 0/1 and PASI 90 response rates of 81% and 78%, respectively; whereas the corresponding rates in the withdrawal group were 7% and 4% (p<0.001). (3) Among patients who withdrew treatment and experienced loss of response (sPGA score ≥3) at or after Week 32 (n=153), 84% regained clear or almost clear skin (sPGA 0/1) after 16 weeks of retreatment with Skyrizi. (4) No new safety signals were observed over the 2-year study period. At Week 16, the incidence of treatment-emergent adverse events was similar between Skyrizi and placebo, and remained stable over time in patients treated with Skyrizi.

AbbVieImmunologyMarek Honczarenko, Ph.D., Vice President of Development, stated: “The results demonstrate that Skyrizi has the potential to provide long-term relief from the symptoms and signs of psoriasis. Our studies show that Skyrizi not only achieves complete clearance of skin plaques in most patients after two years of treatment, but also that retreatment with Skyrizi following relapse can help patients regain skin clearance within 16 weeks. We are pleased to present this positive evidence of long-term efficacy, which supports the long-term efficacy and safety of Skyrizi for the treatment of adults with moderate-to-severe psoriasis.””

Psoriasis is the most prevalent in the United StatesAutoimmunitySexually transmitted diseases, affecting 7.5 million people.Skyrizi is a novel anti-inflammatory drug co-developed by AbbVie and Boehringer Ingelheim, with AbbVie holding global commercialization rights. The drug received approval from the European Union and the United States in the first half of this year for the treatment of adult patients with moderate-to-severe plaque psoriasis. Skyrizi is administered via subcutaneous injection at a recommended dose of 150 mg (two 75 mg injections), given at weeks 0 and 4, followed by maintenance dosing every three months (12 weeks). Skyrizi can be administered in a hospital setting or self-injected after appropriate training.

The active pharmaceutical ingredient of Skyrizi is risankizumab, a monoclonal antibody that selectively blocks interleukin-23 (IL-23), an immune-inflammatory mediator in the body, by specifically targeting the IL-23p19 subunit. IL-23 is a cytokine believed to play a key role in many chronic immune-mediated diseases. Currently, Skyrizi is in Phase III clinical trials for the treatment of psoriasis, Crohn's disease, and psoriatic arthritis.

Skyrizi is entering a highly crowded market, where it will compete with multiple drugs, including:NovartisCosentyx and Ilaris,Eli Lillysuch as Eli Lilly’s Taltz, Valeant’s Siliq, Johnson & Johnson’s Tremfya, and Sun Pharma’s Ilumya. Among these drugs, Tremfya and Ilumya are also biologic therapies that selectively target IL-23. Nevertheless, despite all this competition, the industry remains highly optimistic about Skyrizi’s commercial prospects. The pharmaceutical market research firm EvaluatePharma predicts that the drug’s annual sales will reach $2.2 billion in 2024. (Bioon.com)

Original Source:AbbVie Official Website