Data from Pharmawand - Curated by EPG Health - Date added 13 March 2019
Sun Pharmaceutical Industries Ltd. announced that one of its wholly owned subsidiaries presented new Ilumya (tildrakizumab-asmn) clinical insights at the 2019 American Academy of Dermatology (AAD) Annual Meeting, including long-term data showing sustained skin clearance in some patients living with moderate-to-severe plaque psoriasis after three years of ongoing treatment with Ilumya. These findings from the Phase III reSURFACE 1 and reSURFACE 2 studies showed sustained response by some patients over time and Ilumya was well tolerated with low rates of adverse events. After up to 5 years of treatment, all prespecified adverse events were reported at rates <1.6 and <1.3 events per 100 patient-years in reSURFACE 1 and reSURFACE 2, respectively.
Of the adverse events of interest, severe infections (1.2 and 1.5 events per 100 patient-years, respectively) and malignancies (1.2 and 0.5 events per 100 patient-years, respectively) were the most frequently reported. Results from bio-naïve and bio-experienced patients showed that treatment with Ilumya achieved a PASI ?50 response at Week 28 and was maintained or continued to increase at Week 52, regardless of the patient’s previous exposure to biologic treatment.
Furthermore, additional one-year data analyses presented during the 2019 AAD Annual Meeting show that Iluyma is similarly effective and safe for moderate-to-severe plaque psoriasis patients who have the common condition metabolic syndrome and those who do not. People with psoriasis are predisposed to metabolic syndrome, and psoriasis has been shown to increase the prevalence of metabolic syndrome by three-fold. Patients with moderate-to-severe plaque psoriasis treated with Ilumya 100 mg who achieved PASI 75 at Week 52 were comparable between those with metabolic syndrome (84% [0.04]) and without (90% [0.02]) and reported similar adverse events, with no reports of cardiovascular events or diabetes worsening by metabolic syndrome status. The most common treatment-emergent adverse event was infection, occurring in 50.6% [n=40] of patients with metabolic syndrome and 53.1% [n=154] of patients without. The most commonly reported serious adverse events (>1.5% of patients with ?1 SAE) in patients with metabolic syndrome were gastrointestinal and cardiac disorders.
Additional analyses used the 10-year Markov model to demonstrate the cost effectiveness of Ilumya as a first-line treatment. The data results demonstrated that Ilumya is among the most cost-effective options compared to other biologic options including secukinumab, guselkumab, ixekizumab, adalimumab, ustekinumab, and etanercept.