Clara Grazia Chisari, Joe Guadagno, Peyman Adjamian, Carlos Vila Silvan, Teresa Greco, Makarand Bagul, Francesco Patti
{"title":"多发性硬化症相关痉挛患者接受那比克西莫司治疗后痉挛类别变化的事后评估。","authors":"Clara Grazia Chisari, Joe Guadagno, Peyman Adjamian, Carlos Vila Silvan, Teresa Greco, Makarand Bagul, Francesco Patti","doi":"10.1177/17562864231195513","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Over 80% of individuals with multiple sclerosis (MS) experience MS-associated spasticity (MSS). In many European countries, after failure of first-line treatments, moderate or severe MSS can be treated with nabiximols, a cannabis-based add-on treatment.</p><p><strong>Objective: </strong>This <i>post hoc</i> analysis assessed the shift of participants treated with nabiximols from higher (severe or moderate) to lower (moderate or mild/none) spasticity.</p><p><strong>Methods: </strong>Previously published data from two randomised controlled trials (RCTs), GWSP0604 (NCT00681538) and SAVANT (EudraCT2015-004451-40), and one large real-world study (consistent with EU label), all enriched for responders, were re-analysed. Spasticity severity, measured using the 0-10 numerical rating scale (spasticity NRS), was categorised as none/mild (score <4), moderate (score ⩾4-7), or severe (score ⩾7).</p><p><strong>Results: </strong>In the two RCTs, the shift of participants with severe MSS into a lower category was significantly greater at week 12 for those receiving nabiximols <i>versus</i> placebo [GWSP0604: OR (95% CI), 4.4 (1.4, 14.2), <i>p</i> = 0.0125; SAVANT: 5.2 (1.2, 22.3), <i>p</i> = 0.0267]. In all three studies, over 80% of assessed patients with severe spasticity at baseline reported a shift into a lower category of spasticity after 12 weeks.</p><p><strong>Conclusions: </strong>A meaningful proportion of MSS patients treated with nabiximols shifted to a lower category of spasticity severity, typically maintained to the end of the 12-week study period.</p>","PeriodicalId":22980,"journal":{"name":"Therapeutic Advances in Neurological Disorders","volume":"16 ","pages":"17562864231195513"},"PeriodicalIF":4.7000,"publicationDate":"2023-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c5/03/10.1177_17562864231195513.PMC10515604.pdf","citationCount":"0","resultStr":"{\"title\":\"A <i>post hoc</i> evaluation of the shift in spasticity category in individuals with multiple sclerosis-related spasticity treated with nabiximols.\",\"authors\":\"Clara Grazia Chisari, Joe Guadagno, Peyman Adjamian, Carlos Vila Silvan, Teresa Greco, Makarand Bagul, Francesco Patti\",\"doi\":\"10.1177/17562864231195513\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Over 80% of individuals with multiple sclerosis (MS) experience MS-associated spasticity (MSS). In many European countries, after failure of first-line treatments, moderate or severe MSS can be treated with nabiximols, a cannabis-based add-on treatment.</p><p><strong>Objective: </strong>This <i>post hoc</i> analysis assessed the shift of participants treated with nabiximols from higher (severe or moderate) to lower (moderate or mild/none) spasticity.</p><p><strong>Methods: </strong>Previously published data from two randomised controlled trials (RCTs), GWSP0604 (NCT00681538) and SAVANT (EudraCT2015-004451-40), and one large real-world study (consistent with EU label), all enriched for responders, were re-analysed. Spasticity severity, measured using the 0-10 numerical rating scale (spasticity NRS), was categorised as none/mild (score <4), moderate (score ⩾4-7), or severe (score ⩾7).</p><p><strong>Results: </strong>In the two RCTs, the shift of participants with severe MSS into a lower category was significantly greater at week 12 for those receiving nabiximols <i>versus</i> placebo [GWSP0604: OR (95% CI), 4.4 (1.4, 14.2), <i>p</i> = 0.0125; SAVANT: 5.2 (1.2, 22.3), <i>p</i> = 0.0267]. In all three studies, over 80% of assessed patients with severe spasticity at baseline reported a shift into a lower category of spasticity after 12 weeks.</p><p><strong>Conclusions: </strong>A meaningful proportion of MSS patients treated with nabiximols shifted to a lower category of spasticity severity, typically maintained to the end of the 12-week study period.</p>\",\"PeriodicalId\":22980,\"journal\":{\"name\":\"Therapeutic Advances in Neurological Disorders\",\"volume\":\"16 \",\"pages\":\"17562864231195513\"},\"PeriodicalIF\":4.7000,\"publicationDate\":\"2023-09-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c5/03/10.1177_17562864231195513.PMC10515604.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Neurological Disorders\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17562864231195513\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Neurological Disorders","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17562864231195513","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
A post hoc evaluation of the shift in spasticity category in individuals with multiple sclerosis-related spasticity treated with nabiximols.
Background: Over 80% of individuals with multiple sclerosis (MS) experience MS-associated spasticity (MSS). In many European countries, after failure of first-line treatments, moderate or severe MSS can be treated with nabiximols, a cannabis-based add-on treatment.
Objective: This post hoc analysis assessed the shift of participants treated with nabiximols from higher (severe or moderate) to lower (moderate or mild/none) spasticity.
Methods: Previously published data from two randomised controlled trials (RCTs), GWSP0604 (NCT00681538) and SAVANT (EudraCT2015-004451-40), and one large real-world study (consistent with EU label), all enriched for responders, were re-analysed. Spasticity severity, measured using the 0-10 numerical rating scale (spasticity NRS), was categorised as none/mild (score <4), moderate (score ⩾4-7), or severe (score ⩾7).
Results: In the two RCTs, the shift of participants with severe MSS into a lower category was significantly greater at week 12 for those receiving nabiximols versus placebo [GWSP0604: OR (95% CI), 4.4 (1.4, 14.2), p = 0.0125; SAVANT: 5.2 (1.2, 22.3), p = 0.0267]. In all three studies, over 80% of assessed patients with severe spasticity at baseline reported a shift into a lower category of spasticity after 12 weeks.
Conclusions: A meaningful proportion of MSS patients treated with nabiximols shifted to a lower category of spasticity severity, typically maintained to the end of the 12-week study period.
期刊介绍:
Therapeutic Advances in Neurological Disorders is a peer-reviewed, open access journal delivering the highest quality articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of neurology. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in neurology, providing a forum in print and online for publishing the highest quality articles in this area.