Satisfaction with alemtuzumab in relapsing multiple sclerosis patients: Results from the real-world PRO-ACT study
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...
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| Vydané v: | Multiple sclerosis journal - experimental, translational and clinical Ročník 8; číslo 4; s. 20552173221135888 |
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| Hlavní autori: | , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
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London, England
SAGE Publications
01.10.2022
Sage Publications Ltd |
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| ISSN: | 2055-2173, 2055-2173 |
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| Abstract | 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. |
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| AbstractList | 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.BackgroundPatient-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.To present results from the real-world PRO-ACT study in patients with multiple sclerosis who switched to alemtuzumab from another disease-modifying therapy.ObjectiveTo present results from the real-world PRO-ACT study in patients with multiple sclerosis who switched to alemtuzumab from another disease-modifying therapy.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).MethodsThis 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).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).ResultsOf 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).The primary endpoint was met; the safety of alemtuzumab was consistent with pivotal studies.ConclusionsThe primary endpoint was met; the safety of alemtuzumab was consistent with pivotal studies. 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. 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. |
| Author | Wray, Sibyl Gandhi, Roopali Hunter, Samuel F Nicholas, Jacqueline A Arroyo, Rafael Melas-Melt, Lydie Travis, Lori Miller, Tamara A Chirieac, Magdalena Rawlings, Andreea M Roesch, Nora Rodrigues, Amelie Khatri, Bhupendra Jacques, Francois |
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ISPOR 20th Annual International Meeting ident: bibr18-20552173221135888 – ident: bibr22-20552173221135888 doi: 10.1177/20552173221104009 – ident: bibr2-20552173221135888 doi: 10.1177/1352458518814117 – ident: bibr12-20552173221135888 doi: 10.1177/1756286420982134 – volume: 2014 start-page: 203183 year: 2014 ident: bibr7-20552173221135888 publication-title: Mult Scler Int – ident: bibr17-20552173221135888 doi: 10.1186/1471-2377-13-37 – ident: bibr11-20552173221135888 doi: 10.1177/1352458519849796 – ident: bibr8-20552173221135888 doi: 10.1177/1352458516677589 – ident: bibr13-20552173221135888 doi: 10.1186/1477-7525-2-12 – volume: 2013 start-page: 524894 year: 2013 ident: bibr14-20552173221135888 publication-title: Mult Scler Int – ident: bibr10-20552173221135888 doi: 10.1016/S0140-6736(12)61768-1 – volume: 75 start-page: 266 year: 2004 ident: bibr15-20552173221135888 publication-title: J Neurol Neurosurg Psychiatry doi: 10.1136/jnnp.2003.012666 – ident: bibr21-20552173221135888 doi: 10.7224/1537-2073.2014-030 – ident: bibr16-20552173221135888 doi: 10.3310/hta8090 – ident: bibr26-20552173221135888 doi: 10.1007/s00415-012-6577-4 – ident: bibr4-20552173221135888 doi: 10.1016/j.jval.2012.07.010 – ident: bibr6-20552173221135888 doi: 10.2165/11592160-000000000-00000 – ident: bibr19-20552173221135888 doi: 10.1016/j.jclinepi.2010.08.003 – ident: bibr24-20552173221135888 doi: 10.1007/s00415-017-8676-8 – ident: bibr9-20552173221135888 doi: 10.1016/S0140-6736(12)61769-3 – ident: bibr23-20552173221135888 doi: 10.1186/1477-7525-10-155 – ident: bibr3-20552173221135888 doi: 10.1016/B978-0-444-52001-2.00011-X – ident: bibr25-20552173221135888 doi: 10.1016/j.apmr.2015.09.027 – ident: bibr5-20552173221135888 doi: 10.1186/1471-2377-14-115 – volume: 18 start-page: P545 year: 2012 ident: bibr20-20552173221135888 publication-title: Mult Scler doi: 10.1177/1352458512458011 |
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Patient-reported outcomes are increasingly used in the management of patients with multiple sclerosis to understand the patient's perspective of... Background Patient-reported outcomes are increasingly used in the management of patients with multiple sclerosis to understand the patient's perspective of... Patient-reported outcomes are increasingly used in the management of patients with multiple sclerosis to understand the patient's perspective of disease and... |
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| Title | Satisfaction with alemtuzumab in relapsing multiple sclerosis patients: Results from the real-world PRO-ACT study |
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