Real-World Evaluation of the Tolerability to Onabotulinum Toxin A: The RETO Study
Onabotulinumtoxin A (onabotA) has shown efficacy in chronic migraine (CM), with good tolerability and a low rate of adverse effects, most of them not severe. The aim of this study is to evaluate tolerability and adverse effects of onabotA in clinical practice and to analyze if there is a relationshi...
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| Format: | Article |
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MDPI AG
2022-12-01
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| Series: | Toxins |
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| Online Access: | https://www.mdpi.com/2072-6651/14/12/850 |
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| author | David García-Azorín Blanca Martínez María Gutiérrez Marina Ruiz-Piñero Ana Echavarría Álvaro Sierra Ángel L. Guerrero |
| author_facet | David García-Azorín Blanca Martínez María Gutiérrez Marina Ruiz-Piñero Ana Echavarría Álvaro Sierra Ángel L. Guerrero |
| author_sort | David García-Azorín |
| collection | DOAJ |
| description | Onabotulinumtoxin A (onabotA) has shown efficacy in chronic migraine (CM), with good tolerability and a low rate of adverse effects, most of them not severe. The aim of this study is to evaluate tolerability and adverse effects of onabotA in clinical practice and to analyze if there is a relationship between tolerability to treatment administration, adverse effects’ (AEs) occurrence and clinical response. We included patients with CM that received treatment with onabotA for the first time. Tolerability to treatment was evaluated by a 0–10 numeric rating scale (0: worst possible, 10: optimal tolerability). We assessed the presence of AEs by using a standardized questionnaire. Treatment response was based on the 50 and 75% responder rate between weeks 20 and 24, compared with the baseline, according to headache diaries. We analyzed whether the tolerability was associated with a higher frequency of AEs or a higher probability of clinical response. We included 105 patients, 87.7% female, with an age of 43.9 ± 10.7 years. Mean tolerability was 7.8/10 and 7.2/10 in the first and second onabotA administration, respectively. AEs were reported by (first-second) 71.4–68.6% patients. The percentage of patients with a 50% response was 56.3%. There was no association between tolerability and AEs’ occurrence or clinical response. |
| first_indexed | 2024-03-09T15:46:43Z |
| format | Article |
| id | doaj.art-7041dd73690641efa3b1c377671da686 |
| institution | Directory Open Access Journal |
| issn | 2072-6651 |
| language | English |
| last_indexed | 2024-03-09T15:46:43Z |
| publishDate | 2022-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Toxins |
| spelling | doaj.art-7041dd73690641efa3b1c377671da6862023-11-24T18:26:51ZengMDPI AGToxins2072-66512022-12-01141285010.3390/toxins14120850Real-World Evaluation of the Tolerability to Onabotulinum Toxin A: The RETO StudyDavid García-Azorín0Blanca Martínez1María Gutiérrez2Marina Ruiz-Piñero3Ana Echavarría4Álvaro Sierra5Ángel L. Guerrero6Headache Unit, Neurology Department, Hospital Clínico Universitario de Valladolid, 47005 Valladolid, SpainHeadache Unit, Neurology Department, Hospital Clínico Universitario de Valladolid, 47005 Valladolid, SpainHeadache Unit, Neurology Department, Hospital Clínico Universitario de Valladolid, 47005 Valladolid, SpainHeadache Unit, Neurology Department, Hospital Clínico Universitario de Valladolid, 47005 Valladolid, SpainHeadache Unit, Neurology Department, Hospital Clínico Universitario de Valladolid, 47005 Valladolid, SpainHeadache Unit, Neurology Department, Hospital Clínico Universitario de Valladolid, 47005 Valladolid, SpainHeadache Unit, Neurology Department, Hospital Clínico Universitario de Valladolid, 47005 Valladolid, SpainOnabotulinumtoxin A (onabotA) has shown efficacy in chronic migraine (CM), with good tolerability and a low rate of adverse effects, most of them not severe. The aim of this study is to evaluate tolerability and adverse effects of onabotA in clinical practice and to analyze if there is a relationship between tolerability to treatment administration, adverse effects’ (AEs) occurrence and clinical response. We included patients with CM that received treatment with onabotA for the first time. Tolerability to treatment was evaluated by a 0–10 numeric rating scale (0: worst possible, 10: optimal tolerability). We assessed the presence of AEs by using a standardized questionnaire. Treatment response was based on the 50 and 75% responder rate between weeks 20 and 24, compared with the baseline, according to headache diaries. We analyzed whether the tolerability was associated with a higher frequency of AEs or a higher probability of clinical response. We included 105 patients, 87.7% female, with an age of 43.9 ± 10.7 years. Mean tolerability was 7.8/10 and 7.2/10 in the first and second onabotA administration, respectively. AEs were reported by (first-second) 71.4–68.6% patients. The percentage of patients with a 50% response was 56.3%. There was no association between tolerability and AEs’ occurrence or clinical response.https://www.mdpi.com/2072-6651/14/12/850onabotAchronic migraineadverse effects |
| spellingShingle | David García-Azorín Blanca Martínez María Gutiérrez Marina Ruiz-Piñero Ana Echavarría Álvaro Sierra Ángel L. Guerrero Real-World Evaluation of the Tolerability to Onabotulinum Toxin A: The RETO Study Toxins onabotA chronic migraine adverse effects |
| title | Real-World Evaluation of the Tolerability to Onabotulinum Toxin A: The RETO Study |
| title_full | Real-World Evaluation of the Tolerability to Onabotulinum Toxin A: The RETO Study |
| title_fullStr | Real-World Evaluation of the Tolerability to Onabotulinum Toxin A: The RETO Study |
| title_full_unstemmed | Real-World Evaluation of the Tolerability to Onabotulinum Toxin A: The RETO Study |
| title_short | Real-World Evaluation of the Tolerability to Onabotulinum Toxin A: The RETO Study |
| title_sort | real world evaluation of the tolerability to onabotulinum toxin a the reto study |
| topic | onabotA chronic migraine adverse effects |
| url | https://www.mdpi.com/2072-6651/14/12/850 |
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