Treatment Satisfaction in Patients with Highly-active Relapsing Multiple Sclerosis Treated with Cladribine Tablets: CLARIFY-MS Study Interim Analysis
Bruno Brochet1,2, Raymond Hupperts3, Dawn Langdon4, Alessandra Solari5, Fredrik Piehl6, Jeanette Lechner-Scott7,8, Xavier Montalban9, Krzysztof Selmaj10, Martin Valis11, Eva Havrdova12, Konrad Rejdak13, Francesco Patti14, Nektaria Alexandri15, Axel Nolting15, Birgit Keller15
1INSERM U 1215, University of Bordeaux, 2Department of Neurology, University Hospital of Bordeaux, 3Zuyderland Medisch Centrum Sittard, Maastricht University Medical Center, 4Department of Psychology, Royal Holloway, University of London, 5Foundation IRCCS Neurological Institute C. Besta, 6Department of Clinical Neuroscience, Karolinska Institutet, 7University of Newcastle, 8Department of Neurology, John Hunter Hospital, 9Department of Neurology-Neuroimmunology, Centre d’Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d’Hebron, 10Center for Neurology, Medical University of Lodz, 11Charles University and University Hospital, 12Charles University, 13Medical University of Lublin, 14Azienda Ospedaliera-Universitaria, “Policlinico Vittorio Emanuele”, 15Merck KGaA, Darmstadt, Germany
To present an interim analysis of CLARIFY-MS (NCT03369665), 6 months after initiating treatment with cladribine tablets, assessing treatment satisfaction through the Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4 and safety through the collection of safety assessments in highly-active relapsing multiple sclerosis (RMS) patients.
The CLARIFY-MS aims to assess the impact of cladribine tablets (3.5mg/kg over 2 years; CT3.5) on health-related quality of life (HRQoL) and treatment satisfaction in patients with highly-active RMS.
CLARIFY-MS is an ongoing phase IV, open label, single arm, multicenter, 2-year study. RMS patients received CT3.5, with 2 weeks of active treatment per course (week 1 and 5 of each year). TSQM v1.4 was used to assess patient-reported treatment satisfaction (a score of 100 is the best possible rating). Treatment-emergent adverse events (TEAEs), serious adverse events (AEs) and lymphocyte counts were recorded.
Treatment satisfaction: Of 554 patients screened, 482 received cladribine tablets. The age and Expanded Disability Status Scale adjusted global treatment satisfaction score (95% confidence interval) at Month 6 was 70.0 (66.6–73.5). Treatment-experienced patients (prior treatment with disease-modifying drugs [DMDs]) reported similar treatment satisfaction scores to DMD-naïve patients (70.2 vs 68.7). At Month 6, >75% of patients rated the TSQM side effects score with 100. Mean side effects score, 91.9; mean convenience, 86.6. Safety: 275 patients (57.1%) experienced ≥1 TEAE, most commonly headache and lymphopenia. Most post-baseline lymphopenias were grade 1-2; 33 patients (6.8%) experienced grade 3 lymphopenia, no grade 4 lymphopenia was observed.
Interim analysis of CLARIFY-MS found that at 6 months, patients were generally satisfied with cladribine tablets treatment. The convenience of cladribine tablets treatment and side effect profile were especially important to patients. There were few serious adverse events in the first 6 months following cladribine tablets treatment; no grade 4 lymphopenia was observed.