The following article is part of conference coverage from the 2019 Annual Meeting of the Consortium of Multiple Sclerosis Centers, in Seattle, Washington. Neurology Advisor‘s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from CMSC 2019.
SEATTLE — Despite the occurrence of thyroid adverse events (AEs) or their severity, AEs had a minimal impact on quality of life (QOL) for patients with relapsing-remitting multiple sclerosis (MS) who had been treated with alemtuzumab, according to research presented at the 33rd Annual Meeting of the Consortium of Multiple Sclerosis Centers, held May 28 through June 1, 2019, in Seattle, Washington.
Researchers of the CARE-MS trials (trial registration: NCT00530348, NCT00548405) demonstrated that alemtuzumab significantly improved outcomes for patients with relapsing-remitting MS compared with subcutaneous interferon B-1a over 2 years of treatment as well as in a 4-year extension study (NCT00930553), during which 56% of patients did not receive further treatment beyond the initial course. Thyroid AEs were the most common autoimmune AE in these trials, and this analysis examined its impact on QOL over 6 years in pooled CARE-MS patients.
Participants received 2 courses of alemtuzumab treatment, with additional courses or other disease-modifying therapies as needed during the extension. The QOL outcomes for patients with or without thyroid AEs were assessed using a Short-Form 36-Item (SF-36) survey mental component summary (MCS) and physical component summary (PCS), EuroQol 5-dimension visual analogue scale (EQ-5D VAS), and Functional Assessment of MS (FAMS), with higher scores indicating improvement. Testing of thyroid function was performed at baseline and then quarterly. To examine QOL at the time of the onset of thyroid AEs, year 3 QOL outcomes were analyzed in participants with onset of thyroid AEs in year 3.
Among the 811 pooled alemtuzumab treated participants over 6 years, 37% had nonserious thyroid AEs, and 5% had serious thyroid AEs. At year 6, QOL outcomes were improved or similar to baseline scores in participants without thyroid AEs (median change from baseline, FAMS: 4.0, SF-36 PCS: 1.2, SF-36 MCS: 0.9, EQ-5D VAS: 2.0), as well as in those with nonserious thyroid AEs (FAMS: 4.0, SF-36 PCS: 0.8, SF-36 MCS: 2.4, EQ-5D VAS: 2.0) or serious thyroid AEs (FAMS: 2.5, SF-36 PCS: -0.1). At year 6, SF-36 MCS and EQ-5D VAS scores in participants with serious thyroid AEs were lower than at baseline (median change from baseline, -2.5 and -5.0, respectively). In each group, most participants showed improved or stable SF-36 MCS and PCS scores (SF-36 MCS: non-serious [80.7%] and serious [62.9%]; SF-36 PCS: 80.6% and 77.1%). Among patients experiencing year 3 thyroid AE onset, minimal differences were observed in QOL outcomes before onset in year 2 and during onset in year 3.
Study investigators conclude, “These findings suggest minimal impact of thyroid AEs on QOL despite the occurrence or seriousness of thyroid AEs.”
Study supported by Sanofi and Bayer HealthCare Pharmaceuticals.
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Honeycutt WD, Bertolotto A, Ziemssen T, et al. Alemtuzumab improves quality of life in relapsing-remitting multiple sclerosis patients who developed thyroid adverse events: 6-year follow-up. Presented at: The 33rd Annual Meeting of the Consortium of Multiple Sclerosis Centers; May 28-June 1, 2019; Seattle, WA. Abstract QOL05.