MedicalResearch.com Interview with:
Dr. Kristian Reich
Professor of Dermatology at the Georg-August-University Göttingen and inflammation specialist Dermatologikum Hamburg in Germany
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: While there is ongoing research into the causes and triggers of psoriasis, recent studies have identified IL-23 as a main driver of the IL-23/IL-17 pathway which is now thought to be the predominant pathway in the psoriasis inflammatory cascade. Selective Inhibition of IL-23 may present a new targeted strategy for treating patients with the condition. The hope for molecules selectively targeting IL-23, specifically the p19 component of the cytokine, is that newer therapies, like tildrakizumab, can more selectively control the disease allowing more patients to achieve higher and even more durable clinical responses.
The two pivotal Phase-3 studies (reSURFACE 1 and 2) evaluated the efficacy and safety of the IL-23 inhibitor tildrakizumab in adult patients with moderate-to-severe plaque psoriasis, and results through week 28 were presented for the first time as part of the Late Breaking News Session at EADV.
In the reSURFACE 1 and 2 pivotal Phase-3 studies, tildrakizumab, a selective IL-23p19 inhibitor, was evaluated against placebo and etanercept to assess efficacy, safety and tolerability. The co-primary efficacy endpoint of the two placebo-controlled studies was a) the proportion of patients with Psoriasis Area Sensitivity Index 75 (PASI 75) response at week 12 compared to placebo and the proportion of participants with a Physician’s Global Assessment (PGA) score of clear or minimal with at least a 2 grade reduction from baseline at week 12 compared to placebo. The reSURFACE 2 also included an etanercept comparator arm, with a key secondary endpoint comparing tildrakizumab and etanercept on PASI 75 and PGA. Other co-secondary endpoints of both placebo controlled studies included PASI 90 and PASI 100 responses at week 12 and PASI 75, 90 and 100 and PGA responses from baseline at Week 28.
In the trials, an average of 63 percent of patients achieved 75 percent skin clearance (PASI 75) by week 12 after only two injections, and 77 percent achieved PASI 75 after 28 weeks and three injections of the 100 mg dose of tildrakizumab. Similarly, an average of 57 percent and 66 percent of patients had a PGA score of “clear” or “minimal” with the 100 mg dose at weeks 12 and 28 respectively. Those receiving the 200 mg dose also saw an average of 64 percent and 78 percent of patients achieving PASI 75 at weeks 12 and 28 respectively. Also, 59 percent and 69 percent of the patients had PGA score of “clear” or “minimal” at weeks 12 and 28 respectively.
The data further showed that a higher number of patients on tildrakizumab achieved PASI 90 and 100 compared to placebo and etanercept. Additionally, the overall safety profile of tildrakizumab in both Phase-3 clinical trials was consistent with the safety data observed in previously reported studies, with low rates of serious adverse events reported that were and similar across the treatment groups.
MedicalResearch.com: What should readers take away from your report?
Response: Tildrakizumab significantly improved skin clearance to achieve the primary end point in both Phase-3 studies, offering a potential new treatment that helps people living with moderate-to-severe psoriasis and further validating the critical role of the IL-23 as a key regulatory cytokine helping to control the inflammatory process of the condition.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: In order to better understand the full potential of tildrakizumab within the concert of IL-23p19 inhibitors and other novel targeted therapies for psoriasis, we will need to look at the long-term efficacy and safety data. I look forward to seeking additional data from the reSURFACE trials, including data to week 52 and beyond and safety and efficacy data up to five years that will be a part of future presentations and publications.
MedicalResearch.com: Is there anything else you would like to add?
Response: For patients with psoriasis, their condition is always top of mind and they struggle on a daily basis with the often debilitating effects of this chronic condition. These initial reSURFACE Phase-3 data indicate that clinical responses to tildrakizumab increased over time offering a potential new treatment option with quarterly dosing for the many people living with this disease.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Reich K, et al. Tildrakizumab, selective IL-23p19 antibody, in the treatment of chronic plaque psoriasis: results from two randomized, controlled, Phase 3 trials (reSURFACE 1 and reSURFACE 2) [abstract]. Presented as a late breaking abstract at the European Academy of Dermatology and Venereology 2016.October 1, 2016.
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
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