PMID- 32410147 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20210112 IS - 2193-8253 (Print) IS - 2193-6536 (Electronic) IS - 2193-6536 (Linking) VI - 9 IP - 2 DP - 2020 Dec TI - 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. PG - 443-457 LID - 10.1007/s40120-020-00191-7 [doi] AB - 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. FAU - Bertolotto, Antonio AU - Bertolotto A AD - SCDO Neurologia-CRESM (Centro Riferimento Regionale Sclerosi Multipla), University Hospital San Luigi Gonzaga, Orbassano, Turin, Italy. antonio.bertolotto@gmail.com. FAU - Arroyo, Rafael AU - Arroyo R AD - Hospital Universitario Quironsalud Madrid, Madrid, Spain. FAU - Celius, Elisabeth G AU - Celius EG AD - Oslo University Hospital Ulleval and Institute of Clinical Medicine, University of Oslo, Oslo, Norway. FAU - Comi, Giancarlo AU - Comi G AD - University Vita-Salute San Raffaele, Milan, Italy. FAU - Havrdova, Eva Kubala AU - Havrdova EK AD - First Medical Faculty, Charles University, Prague, Czech Republic. FAU - Honeycutt, William David AU - Honeycutt WD AD - Neurology Associates, Maitland, FL, USA. FAU - Hunter, Samuel F AU - Hunter SF AD - Advanced Neurosciences Institute, Franklin, TN, USA. FAU - Izquierdo, Guillermo AU - Izquierdo G AD - Vithas Nisa Hospital, Seville, Spain. FAU - Kornek, Barbara AU - Kornek B AD - Medical Neuroscience Cluster, Medical University of Vienna, Vienna, Austria. FAU - Miller, Tamara AU - Miller T AD - Advanced Neurology of Colorado, Fort Collins, CO, USA. FAU - Mitsikostas, Dimos D AU - Mitsikostas DD AD - 1st Neurology Department, Aeginition Hospital, National and Kapodistrian University of Athens, Athens, Greece. FAU - Singer, Barry A AU - Singer BA AD - MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA. FAU - Ziemssen, Tjalf AU - Ziemssen T AD - Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany. FAU - Chung, Luke AU - Chung L AD - Sanofi, Cambridge, MA, USA. FAU - Daizadeh, Nadia AU - Daizadeh N AD - Sanofi, Cambridge, MA, USA. FAU - Afsar, Salman AU - Afsar S AD - Sanofi, Cambridge, MA, USA. FAU - Hashemi, Lobat AU - Hashemi L AD - Sanofi, Cambridge, MA, USA. FAU - Senior, Peter AU - Senior P AD - University of Alberta, Edmonton, AB, Canada. LA - eng PT - Journal Article DEP - 20200514 PL - New Zealand TA - Neurol Ther JT - Neurology and therapy JID - 101637818 PMC - PMC7606412 OAB - This study looked at alemtuzumab, an approved treatment for multiple sclerosis (MS). People who receive alemtuzumab may develop thyroid problems. The researchers wanted to know whether people who developed thyroid problems with alemtuzumab had a worse quality of life compared with those who did not. The researchers measured quality of life using a questionnaire. The questionnaire looked at people's physical, social, and psychological well-being over 6 years. A total of 811 people with MS treated with alemtuzumab took part in this study. Of these, 469 people (58%) did not develop thyroid problems and 342 people (42%) developed thyroid problems. The thyroid problems were serious in 44 people. The researchers observed that thyroid problems during alemtuzumab treatment did not make quality of life worse in most people. Some people with serious thyroid problems had worsened quality of life; this was mostly among people who required certain treatments for their thyroid problems. Quality of life did not change much in people while the thyroid problems were ongoing. This study shows that thyroid problems after alemtuzumab treatment for MS have little negative impact on quality of life for most people. These findings may help healthcare providers make decisions about MS treatment. OABL- eng OTO - NOTNLM OT - Alemtuzumab OT - Health-related quality of life OT - Relapsing-remitting multiple sclerosis OT - Thyroid adverse events EDAT- 2020/05/16 06:00 MHDA- 2020/05/16 06:01 PMCR- 2020/05/14 CRDT- 2020/05/16 06:00 PHST- 2019/12/11 00:00 [received] PHST- 2020/05/16 06:00 [pubmed] PHST- 2020/05/16 06:01 [medline] PHST- 2020/05/16 06:00 [entrez] PHST- 2020/05/14 00:00 [pmc-release] AID - 10.1007/s40120-020-00191-7 [pii] AID - 191 [pii] AID - 10.1007/s40120-020-00191-7 [doi] PST - ppublish SO - Neurol Ther. 2020 Dec;9(2):443-457. doi: 10.1007/s40120-020-00191-7. Epub 2020 May 14.