Treatment with mogamulizumab-kpkc (Poteligeo) led to clinically meaningful improvements in patient-reported skin symptoms and health-related quality of life (HRQOL) among patients with mycosis fungoides (MF) and Sézary syndrome (SS) treated in real-world clinical practice, according to data from the international, observational PROSPER trial (NCT05455931) presented at the
Among 73 enrolled patients (n = 73), which included 56% with MF (n = 41) and 44% with SS (n = 32), mogamulizumab elicited clinically meaningful improvement in skin redness as early as week 4 (P < .001), with the minimal important difference (MID) threshold exceeded from week 4 in both subtypes and the benefit maintained through week 48. Clinically meaningful improvements in skin itch (P < .002) and flaking skin (P < .001) were similarly observed as early as week 4, and skin pain improved by week 12 (P = .001).
"[Patients with] MF/SS reported improvements in their HRQOL and in their symptoms. Improvements were seen as early as 4 weeks and continue to improve in most domains up to 48 weeks," lead study author Julia J. Scarisbrick, MBChB, MD, said in a presentation of the data.
Scarisbrick is a consultant dermatologist at University Hospital Birmingham in Birmingham, United Kingdom.
PROSPER was an international, observational, prospective, mixed-methods study conducted across 19 sites in 6 countries with the aim of describing the real-world experiences of patients with MF/SS receiving mogamulizumab.
Investigators enrolled patients at least 18 years of age with confirmed MF or SS who were eligible to begin treatment with mogamulizumab per reimbursable indication.2 Patients needed to be willing to complete the symptom diary and patient-reported outcome (PRO) assessments. Patients receiving mogamulizumab as part of an interventional clinical trial were not allowed to participate.
PROs were collected for up to 48 weeks of treatment and at discontinuation, captured using a cutaneous T-cell lymphoma (CTCL)–specific Symptom Diary to measure skin itch, skin flaking, skin redness, and skin pain on a numeric rating scale every 24 hours, plus body temperature regulation and sleep problems on a Likert scale over 7 days.1 The Brief Fatigue Inventory (BFI) and the MF/SS-CTCL QOL measure of HRQOL were administered at the first-dose visit and every 12 weeks through week 48.
Among the 73 enrolled patients, 76% had blood involvement, including 66% of those with MF and 88% of those with SS, and 86% had stage IB or higher disease, including 76% of patients with MF and 100% of those with SS. Most patients had received at least 1 prior treatment before initiating mogamulizumab.
Patients received a mean of 9.3 mogamulizumab cycles over a mean of 37 weeks (± 17), and 60% were still receiving mogamulizumab at the end of the 48-week follow-up period.
Real-world activity of mogamulizumab in pretreated MF/SS was also recently reported
Clinically meaningful improvement in skin redness emerged at week 4 (P < .001), which improved further at week 12 and was maintained to week 48, with the MID threshold exceeded from week 4 in both patients with MF and SS. Skin itch improved as early as week 4 (P < .002), with further improvement at week 12 maintained to week 48; the MID threshold was exceeded from week 4 in patients with SS and from week 12 in patients with MF. Flaking skin improved as early as week 4 (P < .001), with further improvement at weeks 12 and 24 maintained to week 48, and the MID threshold exceeded from week 4 in both subtypes. Skin pain showed clinically meaningful improvement at week 12 (P = .001) that was maintained to week 48, with the MID threshold exceeded from week 12 in patients with SS and week 24 in patients with MF.
Rapid improvement in body temperature regulation was reported from baseline, with early improvements observed in both subtypes at week 4 (17% of patients with SS and 14% of MF patients) and numerically greater improvement among patients with MF at weeks 24 and 48.
On the BFI total fatigue score, improvement from baseline was observed at weeks 12 and 48 in SS patients (P = .043 for both time points), with little change in patients with MF; the MID threshold was reached by patients with SS at week 48. For sleep problems, the proportion of all patients with at least a 2-point improvement from baseline rose from 4% at week 4 to 23% at week 24 and 30% at week 48, with improvements seen in both subtypes—28% of SS vs 16% of MF at week 24, and 42% of SS vs 24% of MF at week 48. Consistent with the symptom and fatigue findings, investigators reported improvements in HRQOL as measured by the MF/SS-CTCL QOL instrument over the treatment period.
