Multicentre Observational Study of Treatment Satisfaction with Cladribine Tablets in the Management of Relapsing Multiple Sclerosis in the Arabian Gulf: The CLUE Study
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-interventi...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2023-06-01
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| Series: | Neurology and Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1007/s40120-023-00497-2 |
| _version_ | 1797555537786699776 |
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| author | Jihad Inshasi Samar Farouk Ahmed Shatila Ali Hassan Miklos Szolics Mona Thakre Deeb Kayed Derk Krieger Abubaker Almadani Taoufik Alsaadi Beatrice Benedetti Victoria Mifsud Anu Jacob Shatha Sayegh Amir Boshra Raed Alroughani |
| author_facet | Jihad Inshasi Samar Farouk Ahmed Shatila Ali Hassan Miklos Szolics Mona Thakre Deeb Kayed Derk Krieger Abubaker Almadani Taoufik Alsaadi Beatrice Benedetti Victoria Mifsud Anu Jacob Shatha Sayegh Amir Boshra Raed Alroughani |
| author_sort | Jihad Inshasi |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-10T16:49:57Z |
| format | Article |
| id | doaj.art-920f402b94c34212b388eaf7282a5af9 |
| institution | Directory Open Access Journal |
| issn | 2193-8253 2193-6536 |
| language | English |
| last_indexed | 2024-03-10T16:49:57Z |
| publishDate | 2023-06-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Neurology and Therapy |
| spelling | doaj.art-920f402b94c34212b388eaf7282a5af92023-11-20T11:21:52ZengAdis, Springer HealthcareNeurology and Therapy2193-82532193-65362023-06-011241309131810.1007/s40120-023-00497-2Multicentre Observational Study of Treatment Satisfaction with Cladribine Tablets in the Management of Relapsing Multiple Sclerosis in the Arabian Gulf: The CLUE StudyJihad Inshasi0Samar Farouk1Ahmed Shatila2Ali Hassan3Miklos Szolics4Mona Thakre5Deeb Kayed6Derk Krieger7Abubaker Almadani8Taoufik Alsaadi9Beatrice Benedetti10Victoria Mifsud11Anu Jacob12Shatha Sayegh13Amir Boshra14Raed Alroughani15Rashid Hospital and Dubai Medical College and Dubai Health Authority (DHA)Ibn Sina HospitalSheikh Shakhbout Medical CityTawam HospitalTawam HospitalAl Zahra HospitalMediclinic City HospitalMediclinic City HospitalRashid Hospital and Dubai Medical College and Dubai Health Authority (DHA)American Center for Psychiatry and NeurologyCleveland Clinic Abu DhabiCleveland Clinic Abu DhabiCleveland Clinic Abu DhabiMerck Serono Middle East FZ LtdMerck Serono Middle East FZ LtdAmiri HospitalAbstract 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.https://doi.org/10.1007/s40120-023-00497-2Multiple sclerosisCladribine tabletsPatient-reported outcomesDisease-modifying therapy |
| spellingShingle | Jihad Inshasi Samar Farouk Ahmed Shatila Ali Hassan Miklos Szolics Mona Thakre Deeb Kayed Derk Krieger Abubaker Almadani Taoufik Alsaadi Beatrice Benedetti Victoria Mifsud Anu Jacob Shatha Sayegh Amir Boshra Raed Alroughani Multicentre Observational Study of Treatment Satisfaction with Cladribine Tablets in the Management of Relapsing Multiple Sclerosis in the Arabian Gulf: The CLUE Study Neurology and Therapy Multiple sclerosis Cladribine tablets Patient-reported outcomes Disease-modifying therapy |
| title | Multicentre Observational Study of Treatment Satisfaction with Cladribine Tablets in the Management of Relapsing Multiple Sclerosis in the Arabian Gulf: The CLUE Study |
| title_full | Multicentre Observational Study of Treatment Satisfaction with Cladribine Tablets in the Management of Relapsing Multiple Sclerosis in the Arabian Gulf: The CLUE Study |
| title_fullStr | Multicentre Observational Study of Treatment Satisfaction with Cladribine Tablets in the Management of Relapsing Multiple Sclerosis in the Arabian Gulf: The CLUE Study |
| title_full_unstemmed | Multicentre Observational Study of Treatment Satisfaction with Cladribine Tablets in the Management of Relapsing Multiple Sclerosis in the Arabian Gulf: The CLUE Study |
| title_short | Multicentre Observational Study of Treatment Satisfaction with Cladribine Tablets in the Management of Relapsing Multiple Sclerosis in the Arabian Gulf: The CLUE Study |
| title_sort | multicentre observational study of treatment satisfaction with cladribine tablets in the management of relapsing multiple sclerosis in the arabian gulf the clue study |
| topic | Multiple sclerosis Cladribine tablets Patient-reported outcomes Disease-modifying therapy |
| url | https://doi.org/10.1007/s40120-023-00497-2 |
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