SUN PHARMACEUTICAL INDUSTRIES LTD. Long-term analyses of the reSURFACE 1 and 2 extension studies found that ILUMYA offers sustained and improved results in patients with moderate-to-severe plaque psoriasis who received treatment for up to four years with no new safety concerns recorded.1,2 Furthermore, the safety profile of ILUMYA was reconfirmed in a five-year analysis that demonstrated low and similar exposure-adjusted incidence rates of malignancies from year four to year five. A majority of malignancies were singular events with similar incidence rates as seen in the general US population.3
Another post-hoc analysis of 335 patients who were predominately bio naive showed that those who achieved PASI 50 or higher after 6 months of treatment with ILUMYA saw continued improvement and sustained response rates when they maintained treatment for up to three years. Those patients who achieved PASI 90 at week 28 had rapid improvements as early as week 4.4
ILUMYA 100 mg was well-tolerated, with a low rate of adverse events (AEs) that were comparable or numerically lower than placebo or etanercept based upon exposure-adjusted rates for many AE categories. The most common (1%) adverse reactions associated with ILUMYA are upper respiratory infections, infection site reactions, and diarrhea.
'Notably, 85 percent of the patients included in our analysis had never used a biologic before even though they have been living with psoriasis for over a decade,' said lead investigator
Six additional long-term analyses showed ILUMYA offers similar efficacy and safety results in patients with metabolic syndrome or patients who are over 65 years of age, factors that may make treatment more complex.5 6,7,8,9,10 Metabolic syndrome has a higher prevalence in patients with moderate-to-severe psoriasis compared to the overall population and an impact on response rates to many anti-TNF and IL-17 treatments.8 The analyses found that metabolic syndrome had minimal effect on the positive results seen in people treated with ILUMYA for up to three years and there was no increase in cardiac events or worsening of diabetes, compared to those without metabolic syndrome.
Furthermore, a 10-year cost analysis study revealed that ILUMYA is among the most cost-effective first-line therapies for treating moderate-to-severe plaque psoriasis and is more cost-effective than many other biologics, including risankizumab, secukinumab, guselkumab, ixekizumab, adalimumab, ustekinumab, etanercept, or certolizumab pegol.11
'It is exciting to share this wealth of clinical insights that continue to confirm the potential of ILUMYA to manage moderate-to-severe plaque psoriasis effectively and safely across different types of patients and as a cost-effective, first-line biologic treatment option,' said
About the reSURFACE Extension Studies
The Phase-3 studies (reSURFACE 1 and reSURFACE 2) were randomized, placebo-controlled, multicenter, three-part studies designed to evaluate efficacy and safety of ILUMYA 100 mg and 200 mg in moderate-to-severe plaque psoriasis compared to placebo and comparative drug and to assess safety and tolerability. Participants with at least 50 percent improvement in PASI 50 at base study completion who received ILUMYA within 12 weeks of base study end (week 52 or 64) were eligible to enroll in the extension study and continued on the same ILUMYA dose once every 12 weeks. Researchers evaluated PASI and PGA response (score of 0 or 1 with 2 grade reduction from baseline) and incidence rates for prespecified adverse events, including severe infections, cardiovascular events and drug-related hypersensitivities.
About ILUMYA (tildrakizumab-asmn)
ILUMYA (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, in
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Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and
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