PMID- 36407472 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20221122 IS - 2055-2173 (Print) IS - 2055-2173 (Electronic) IS - 2055-2173 (Linking) VI - 8 IP - 4 DP - 2022 Oct-Dec TI - Satisfaction with alemtuzumab in relapsing multiple sclerosis patients: Results from the real-world PRO-ACT study. PG - 20552173221135888 LID - 10.1177/20552173221135888 [doi] LID - 20552173221135888 AB - BACKGROUND: Patient-reported outcomes are increasingly used in the management of patients with multiple sclerosis to understand the patient's perspective of disease and treatment. These measures provide insights into important factors including treatment satisfaction, physical and psychological function, and quality of life. OBJECTIVE: To present results from the real-world PRO-ACT study in patients with multiple sclerosis who switched to alemtuzumab from another disease-modifying therapy. METHODS: This 24-month, prospective, multicenter, observational study had a primary endpoint of change in overall satisfaction, measured using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4. Secondary endpoints included the Multiple Sclerosis Impact Scale-29 (MSIS-29), Modified Fatigue Impact Scale-5 (MFIS-5), and the Patient-Determined Disease Steps (PDDS). Safety was monitored with adverse events (AEs). RESULTS: Of 199 enrolled patients, improvements were observed in mean TSQM scores for overall satisfaction (baseline, 50.3; year 2, + 13.2; p < 0.0001), effectiveness (49.3 and + 12.2; p < 0.0001), and side effects (77.6 and + 4.5; p = 0.04). Improvements were also observed in MSIS-29 physical (52.4 and -6.0; p < 0.0001), MSIS-29 psychological (53.4 and -7.0; p = 0.0003), and MFIS-5 (12.8 and -1.7; p < 0.0001). Most (95.0%) patients experienced >/= 1 AE (88.4% mild, 67.8% moderate). CONCLUSIONS: The primary endpoint was met; the safety of alemtuzumab was consistent with pivotal studies. CI - (c) The Author(s), 2022. FAU - Wray, Sibyl AU - Wray S AUID- ORCID: 0000-0001-5116-8776 AD - Hope Neurology, Knoxville, TN, USA. FAU - Jacques, Francois AU - Jacques F AUID- ORCID: 0000-0002-6530-9370 AD - Clinique Neuro-Outaouais, Gatineau, Canada. FAU - Miller, Tamara A AU - Miller TA AD - Advanced Neurology of Colorado, Fort Collins, CO, USA. FAU - Nicholas, Jacqueline A AU - Nicholas JA AD - OhioHealth Multiple Sclerosis Center, Riverside Methodist Hospital, Columbus, OH, USA. FAU - Arroyo, Rafael AU - Arroyo R AD - Hospital Universitario Quironsalud Madrid, Madrid, Spain. FAU - Travis, Lori AU - Travis L AD - The MS Center of Arizona, Center for Neurology and Spine, Phoenix, AZ, USA. FAU - Khatri, Bhupendra AU - Khatri B AD - MD Center of Neurological Disorders, Milwaukee, WI, USA. FAU - Chirieac, Magdalena AU - Chirieac M AD - Sanofi, Cambridge, MA, USA. FAU - Gandhi, Roopali AU - Gandhi R AD - Sanofi, Cambridge, MA, USA. FAU - Roesch, Nora AU - Roesch N AD - Sanofi, Cambridge, MA, USA. FAU - Rodrigues, Amelie AU - Rodrigues A AD - Ividata Life Sciences, Levallois-Perret, France. FAU - Melas-Melt, Lydie AU - Melas-Melt L AD - Ividata Life Sciences, Levallois-Perret, France. FAU - Rawlings, Andreea M AU - Rawlings AM AD - Sanofi, Cambridge, MA, USA. FAU - Hunter, Samuel F AU - Hunter SF AD - Advanced Neuroscience Institute, Franklin, TN, USA. LA - eng PT - Journal Article DEP - 20221115 PL - United States TA - Mult Scler J Exp Transl Clin JT - Multiple sclerosis journal - experimental, translational and clinical JID - 101668877 PMC - PMC9669692 OTO - NOTNLM OT - Alemtuzumab OT - disease-modifying therapies OT - multiple sclerosis OT - quality of life COIS- The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: SW reports receiving consulting, principal investigator, and/or speaking fees (Alkermes, Biogen, Celgene, Genentech, Novartis, Sanofi, and TG Therapeutics). FJ reports receiving honoraria for giving presentations, advisory board participation, research funding, and for an infusion clinic (Biogen, Merck Serono, Novartis, Roche, and Sanofi). TAM reports receiving speaking and/or consulting fees (Abbvie, Amgen, Biogen, Biohaven, BMS, Genentech, Lundbeck, Novartis, Reven, Sanofi, and Teva) and research support (Abbvie, Biogen, BMS, Celgene, Elan, EMD Serono, Genentech, Hoffman-La Roche, Ipsen, Merck, Novartis, Sanofi, and Teva). JAN reports receiving research grants (Biogen Idec, Genentech, Novartis, and PCORI) and consulting and/or speaking fees (Alexion, Bristol Myers Squib, EMD Serono, Genentech, Greenwich Biosciences, Novartis, Sanofi, and Viela Bio). RA reports receiving speaking fees from and advisory board participation for Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi, and Teva. LT reports receiving consulting fees (Acorda, Biogen Idec, EMD Serono, Mallinckrodt, Novartis, Pfizer, and Sanofi), and grant/research support (Biogen, EMD Serono, and Sanofi). BK reports consulting/honorarium (Acorda, Alexion, Biogen, Celgene, Genentech, Novartis, Sanofi, Serono, and Teva); contracted research (Alexion, Biogen, Genentech, Novartis, Ra Pharmaceuticals, and Sanofi). MC, RG, NR, and AMR are employees of Sanofi and may hold shares and/or stock options in the company. AR and LMM were employees of Sanofi at the time the study was conducted, and are currently employees of Ividata Life Sciences. SFH reports receiving consulting agreements, speaker honoraria, and grant/research financial support (AbbVie, Adamas, Alexion, Atara, Avanir, Biogen, Janssen, Mallinckrodt, Novartis, Osmotica, Roche, and Sanofi). EDAT- 2022/11/22 06:00 MHDA- 2022/11/22 06:01 PMCR- 2022/11/15 CRDT- 2022/11/21 04:32 PHST- 2022/07/01 00:00 [received] PHST- 2022/10/12 00:00 [accepted] PHST- 2022/11/21 04:32 [entrez] PHST- 2022/11/22 06:00 [pubmed] PHST- 2022/11/22 06:01 [medline] PHST- 2022/11/15 00:00 [pmc-release] AID - 10.1177_20552173221135888 [pii] AID - 10.1177/20552173221135888 [doi] PST - epublish SO - Mult Scler J Exp Transl Clin. 2022 Nov 15;8(4):20552173221135888. doi: 10.1177/20552173221135888. eCollection 2022 Oct-Dec.