Professor Julia Scarisbrick of University of Birmingham on Friday, April 12, 2024, presented interim findings from the Kyowa Kirin, Inc. (Kyowa Kirin, TSE: 4151)-sponsored study, “Real-World Observational Study of Mogamulizumab in Adult Patients with Mycosis Fungoides and Sézary Syndrome (PROSPER)”.
Findings spotlighted in oral presentation at the 5th annual World Congress of Cutaneous Lymphomas meeting in Pasadena, CA PRINCETON, N.J., April 15, 2024 /PRNewswire/ -- Professor Julia Scarisbrick of University of Birmingham on Friday, April 12, 2024, presented interim findings from the Kyowa Kirin, Inc. (Kyowa Kirin, TSE: 4151)-sponsored study, “Real-World Observational Study of Mogamulizumab in Adult Patients with Mycosis Fungoides and Sézary Syndrome (PROSPER)”, a prospective observational study evaluating the real-world impact of mogamulizumab on disease symptoms and health-related quality of life (HRQoL) in patients with these subtypes of cutaneous T-cell lymphoma (CTCL). CTCL is a rare form of non-Hodgkin lymphoma that most prominently affects the skin, presenting as patches, plaques, tumors, or reddening of the entire skin, and may be associated with severe itching. In a proportion of cases, the disease may spread to the lymph nodes, blood, and/or other organs. In the current interim analysis, symptom scores (mean) were reported for 20 adult patients with relapsed or refractory disease (8 MF; 12 SS) over their first 16 weeks of mogamulizumab treatment. Prior to treatment initiation, patients reported their symptom burden using a 1 – 10 numeric scale. Skin itch (6.6), skin redness (6.2), flaking skin (5.9), and skin pain (4.0). Additionally, over half of patients reported having sleep problems either “frequently” or “every night” while 47% reported difficulties regulating body temperature “frequently” or “always.” Improvement in all symptoms was reported within 4 weeks of treatment initiation and by week 16, symptom severity had decreased considerably with the greatest improvement seen in skin redness (-2.9) closely followed by skin itch (-2.7), flaking skin (-2.5) and skin pain (-2.2). Of note, the proportion of patients reporting sleep problems or difficulties regulating body temperature either “frequently” or “always” decreased to less than 20%. “We know that CTCL patients not only suffer from the stress of a cancer diagnosis, but that these stresses are compounded by visual lesions and varying levels of discomfort,” says Scarisbrick, the study’s principal investigator. “The PROSPER study is helping us understand these burdens better and the impact mogamulizumab may have on patients’ symptoms and quality of life.” About PROSPER POTELIGEO® (mogamulizumab-kpkc) Indication Important Safety Information Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction. Infections: Monitor patients for signs and symptoms of infection and treat promptly. Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease. Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications. Adverse Reactions You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Disclosure Notice About Kyowa Kirin View original content to download multimedia:https://www.prnewswire.com/news-releases/first-interim-analysis-of-prosper-study-details-patient-reported-symptom-burden-of-mycosis-fungoides-and-sezary-syndrome-302116170.html SOURCE Kyowa Kirin | ||
Company Codes: Tokyo:4151, OTC-PINK:KYKOY |