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Quality of Life Improves with Alemtuzumab Over 6 Years in Relapsing-Remitting Multiple Sclerosis Patients with or without Autoimmune Thyroid Adverse Events: Post Hoc Analysis of the CARE-MS Studies.
Neurol Ther. 2020 May 14 [Online ahead of print]NT

Abstract

INTRODUCTION

In clinical trials of alemtuzumab, autoimmune thyroid adverse events (AEs) were frequent. Here, we assess the impact of thyroid AEs on health-related quality of life (HRQL) in alemtuzumab-treated patients with relapsing-remitting multiple sclerosis (RRMS).

METHODS

In phase 3 CARE-MS I (NCT00530348) and II (NCT00548405) trials, patients with RRMS were administered alemtuzumab 12 mg/day on 5 consecutive days at baseline and on 3 consecutive days 12 months later. Patients could participate in an extension study (NCT00930553) through year 6. HRQL was assessed at baseline and annually using the Functional Assessment of Multiple Sclerosis (FAMS), EuroQoL-5 Dimension Visual Analog Scale (EQ-5D VAS), and 36-Item Short-Form Survey (SF-36) questionnaires. Outcomes were analyzed in patients with or without thyroid AEs (nonserious or serious). A subset of patients with thyroid AEs was analyzed to assess HRQL before and during the onset of thyroid AEs.

RESULTS

A total of 811 CARE-MS patients were treated with alemtuzumab. Of these, 342 (42%) patients experienced thyroid AEs over 6 years; serious thyroid AEs occurred in 44 (5%) patients. At year 6, HRQL outcomes generally remained slightly improved or similar to core study baseline in alemtuzumab-treated patients with or without thyroid AEs: FAMS (least-squares mean change from baseline without thyroid AEs, 0.7; with nonserious thyroid AEs, 5.1; with serious thyroid AEs, - 5.3), EQ-5D VAS (2.0; 3.0; - 6.8), SF-36 mental component summary (MCS [0.6; 1.6; - 2.8]), SF-36 physical component summary (PCS [0.8; 1.0; 1.1]). Over 6 years, 63-82% of patients in each group had improved/stable SF-36 MCS and PCS scores. Among patients with thyroid AE onset in year 3 (peak incidence), there were minimal differences between HRQL outcomes before onset (year 2) and after onset (year 3).

CONCLUSION

Autoimmune thyroid AEs (serious and nonserious) had minimal impact on HRQL in alemtuzumab-treated patients. These data may aid therapeutic decisions in patients with relapsing MS.

Authors+Show Affiliations

SCDO Neurologia-CRESM (Centro Riferimento Regionale Sclerosi Multipla), University Hospital San Luigi Gonzaga, Orbassano, Turin, Italy. antonio.bertolotto@gmail.com.Hospital Universitario Quirónsalud Madrid, Madrid, Spain.Oslo University Hospital Ullevål and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.University Vita-Salute San Raffaele, Milan, Italy.First Medical Faculty, Charles University, Prague, Czech Republic.Neurology Associates, Maitland, FL, USA.Advanced Neurosciences Institute, Franklin, TN, USA.Vithas Nisa Hospital, Seville, Spain.Medical Neuroscience Cluster, Medical University of Vienna, Vienna, Austria.Advanced Neurology of Colorado, Fort Collins, CO, USA.1st Neurology Department, Aeginition Hospital, National and Kapodistrian University of Athens, Athens, Greece.MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA.Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany.Sanofi, Cambridge, MA, USA.Sanofi, Cambridge, MA, USA.Sanofi, Cambridge, MA, USA.Sanofi, Cambridge, MA, USA.University of Alberta, Edmonton, AB, Canada.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32410147

Citation

Bertolotto, Antonio, et al. "Quality of Life Improves With Alemtuzumab Over 6 Years in Relapsing-Remitting Multiple Sclerosis Patients With or Without Autoimmune Thyroid Adverse Events: Post Hoc Analysis of the CARE-MS Studies." Neurology and Therapy, 2020.
Bertolotto A, Arroyo R, Celius EG, et al. Quality of Life Improves with Alemtuzumab Over 6 Years in Relapsing-Remitting Multiple Sclerosis Patients with or without Autoimmune Thyroid Adverse Events: Post Hoc Analysis of the CARE-MS Studies. Neurology and therapy. 2020.
Bertolotto, A., Arroyo, R., Celius, E. G., Comi, G., Havrdova, E. K., Honeycutt, W. D., Hunter, S. F., Izquierdo, G., Kornek, B., Miller, T., Mitsikostas, D. D., Singer, B. A., Ziemssen, T., Chung, L., Daizadeh, N., Afsar, S., Hashemi, L., & Senior, P. (2020). Quality of Life Improves with Alemtuzumab Over 6 Years in Relapsing-Remitting Multiple Sclerosis Patients with or without Autoimmune Thyroid Adverse Events: Post Hoc Analysis of the CARE-MS Studies. Neurology and Therapy. https://doi.org/10.1007/s40120-020-00191-7
Bertolotto A, et al. Quality of Life Improves With Alemtuzumab Over 6 Years in Relapsing-Remitting Multiple Sclerosis Patients With or Without Autoimmune Thyroid Adverse Events: Post Hoc Analysis of the CARE-MS Studies. Neurology and therapy. 2020 May 14; PubMed PMID: 32410147.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Quality of Life Improves with Alemtuzumab Over 6 Years in Relapsing-Remitting Multiple Sclerosis Patients with or without Autoimmune Thyroid Adverse Events: Post Hoc Analysis of the CARE-MS Studies. AU - Bertolotto,Antonio, AU - Arroyo,Rafael, AU - Celius,Elisabeth G, AU - Comi,Giancarlo, AU - Havrdova,Eva Kubala, AU - Honeycutt,William David, AU - Hunter,Samuel F, AU - Izquierdo,Guillermo, AU - Kornek,Barbara, AU - Miller,Tamara, AU - Mitsikostas,Dimos D, AU - Singer,Barry A, AU - Ziemssen,Tjalf, AU - Chung,Luke, AU - Daizadeh,Nadia, AU - Afsar,Salman, AU - Hashemi,Lobat, AU - Senior,Peter, Y1 - 2020/05/14/ PY - 2019/12/11/received PY - 2020/5/16/entrez PY - 2020/5/16/pubmed PY - 2020/5/16/medline KW - Alemtuzumab KW - Health-related quality of life KW - Relapsing-remitting multiple sclerosis KW - Thyroid adverse events JF - Neurology and therapy N2 - INTRODUCTION: In clinical trials of alemtuzumab, autoimmune thyroid adverse events (AEs) were frequent. Here, we assess the impact of thyroid AEs on health-related quality of life (HRQL) in alemtuzumab-treated patients with relapsing-remitting multiple sclerosis (RRMS). METHODS: In phase 3 CARE-MS I (NCT00530348) and II (NCT00548405) trials, patients with RRMS were administered alemtuzumab 12 mg/day on 5 consecutive days at baseline and on 3 consecutive days 12 months later. Patients could participate in an extension study (NCT00930553) through year 6. HRQL was assessed at baseline and annually using the Functional Assessment of Multiple Sclerosis (FAMS), EuroQoL-5 Dimension Visual Analog Scale (EQ-5D VAS), and 36-Item Short-Form Survey (SF-36) questionnaires. Outcomes were analyzed in patients with or without thyroid AEs (nonserious or serious). A subset of patients with thyroid AEs was analyzed to assess HRQL before and during the onset of thyroid AEs. RESULTS: A total of 811 CARE-MS patients were treated with alemtuzumab. Of these, 342 (42%) patients experienced thyroid AEs over 6 years; serious thyroid AEs occurred in 44 (5%) patients. At year 6, HRQL outcomes generally remained slightly improved or similar to core study baseline in alemtuzumab-treated patients with or without thyroid AEs: FAMS (least-squares mean change from baseline without thyroid AEs, 0.7; with nonserious thyroid AEs, 5.1; with serious thyroid AEs, - 5.3), EQ-5D VAS (2.0; 3.0; - 6.8), SF-36 mental component summary (MCS [0.6; 1.6; - 2.8]), SF-36 physical component summary (PCS [0.8; 1.0; 1.1]). Over 6 years, 63-82% of patients in each group had improved/stable SF-36 MCS and PCS scores. Among patients with thyroid AE onset in year 3 (peak incidence), there were minimal differences between HRQL outcomes before onset (year 2) and after onset (year 3). CONCLUSION: Autoimmune thyroid AEs (serious and nonserious) had minimal impact on HRQL in alemtuzumab-treated patients. These data may aid therapeutic decisions in patients with relapsing MS. SN - 2193-8253 UR - https://www.unboundmedicine.com/medline/citation/32410147/Quality_of_Life_Improves_with_Alemtuzumab_Over_6_Years_in_Relapsing_Remitting_Multiple_Sclerosis_Patients_with_or_without_Autoimmune_Thyroid_Adverse_Events:_Post_Hoc_Analysis_of_the_CARE_MS_Studies_ L2 - https://dx.doi.org/10.1007/s40120-020-00191-7 DB - PRIME DP - Unbound Medicine ER -
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