Multicentre Observational Study of Treatment Satisfaction with Cladribine Tablets in the Management of Relapsing Multiple Sclerosis in the Arabian Gulf: The CLUE Study

Affiliations


Abstract

Introduction: Inconvenient administration and side effects of some disease-modifying therapies (DMTs) for relapsing multiple sclerosis (RMS) can deter adherence. We evaluated treatment satisfaction with cladribine tablets (CladT) for RMS in the Arabian Gulf.

Methods: This was a non-interventional, multicentre, prospective observational study in non-pregnant/lactating adults (aged ≥ 18 years) with RMS eligible for 1st treatment with CladT (EU labelling). The primary outcome was overall treatment satisfaction at 6 months (Treatment Satisfaction Questionnaire for Medication [TSQM]-14, v. 1.4), Global Satisfaction subscale. Secondary endpoints were TSQM-14 scores for convenience, satisfaction with side effects and satisfaction with effectiveness. Patients provided written informed consent.

Results: Of 63 patients screened, 58 received CladT and 55 completed the study. Mean age was 33 ± 9 years; mean weight 73 ± 17 kg; 31% male/69% female; mostly from the United Arab Emirates (52%) or Kuwait (30%). All had RMS (mean 0.9 ± 1.1 relapses in the past year), mean Expanded Disability Status Scale (EDSS) 1.4 ± 1.2; 36% were DMT-naïve. Mean [95% CI] score was high for overall treatment satisfaction (77.8 [73.0-82.6]), ease of use (87.4 [83.7-91.0]), tolerability (94.2 [91.0-97.3]) and effectiveness (76.2 [71.6-80.7]). Scores were similar irrespective of DMT history, age, gender, relapse history or EDSS. No relapses or serious treatment-emergent adverse events (TEAE) occurred. Two severe TEAE occurred (fatigue, headache) and 16% reported lymphopenia (two cases of grade 3 lymphopenia). Absolute lymphocyte counts at baseline and 6 months were 2.2 ± 0.8 × 109/L and 1.3 ± 0.3 × 109/L, respectively.

Conclusions: Treatment satisfaction, ease of use, tolerability and patient-perceived effectiveness for CladT were high, irrespective of baseline demographics, disease characteristics and prior treatment.

Keywords: Cladribine tablets; Disease-modifying therapy; Multiple sclerosis; Patient-reported outcomes.

Conflict of interest statement

Ahmed Shatila received honoraria for lectures (Sanofi-Genzyme, Merck, Genpharm, Roche, Novartis, Boehringeringer Ingelheim, Biologix) and for advisory boards (Sanofi-Genzyme, Roche, Novartis, Pfizer, Biologix); educational conferences travel and registration and hotel accommodation has been sponsored by Sanofi-Genzyme, Merck, Genpharm, Roche, Novartis, Biologix. Raed Alroughani received honoraria as a speaker and for serving in scientific advisory boards from Bayer, Biogen, Merck, Novartis, Roche, and Sanofi. Taoufik Alsaadi Alsaadi received consulting fees, honoraria, and research grants from Novartis, GlaxoSmithKline, Merck, Pfizer, and Hekma. Jihad Inshasi and Samar Farouk received honoraria as a speaker and for serving in scientific advisory boards from Bayer, Biogen, Merck, Novartis, Roche, and Sanofi. Victoria Mifsud received honoraria for participation in Advisory boards from Merck, Roche and Novartis. Amir Boshra and Shatha Sayegh are employees of Merck Serono Middle East FZ-Ltd. Mona Thakre, Abubaker Almadani, Beatrice Benedetti, Deeb Kayed, Derk Krieger, Miklos Szolics, Anu Jacob and Ali Hassan have nothing to disclose beyond the current work.


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