The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray)
Nabiximols (THC/CBD Oromucosal Spray, Sativex) is used as an add-on therapy to treat moderate to severe spasticity of Multiple Sclerosis (MS). To examine the impact of physiotherapy (PT) programs on effectiveness and persistence of nabiximols treatment in people with MS-related spasticity. This is a...
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| Veröffentlicht in: | PloS one 2019-07, Vol.14 (7), p.e0219670-e0219670 |
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| creator | Grimaldi, Alessandro Enrico De Giglio, Laura Haggiag, Shalom Bianco, Assunta Cortese, Antonio Crisafulli, Sebastiano Giuseppe Monteleone, Fabrizia Marfia, Gerola Prosperini, Luca Galgani, Simonetta Mirabella, Massimiliano Centonze, Diego Pozzilli, Carlo Castelli, Letizia |
| description | Nabiximols (THC/CBD Oromucosal Spray, Sativex) is used as an add-on therapy to treat moderate to severe spasticity of Multiple Sclerosis (MS).
To examine the impact of physiotherapy (PT) programs on effectiveness and persistence of nabiximols treatment in people with MS-related spasticity.
This is an observational multicenter study with a follow-up period of 12 weeks, conducted in routine care settings in Italy. Patients with moderate to severe MS-related spasticity who started nabiximols were included. Spasticity was evaluated by the patient-rated 0-10 numerical rating scale (NRS). Clinical data were collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) months after enrollment.
A total of 297 MS patients were selected, 290 completed the 3 months follow-up period. Mean NRS scores were 7.6 ± 1.1 at T0, 5.8 ± 1.4 at T1 and 5.5 ± 1.5 at T2. At T1, 77% of patients reached ≥20% improvement (initial response, IR); 22% reached ≥30% improvement (clinically relevant response, CRR). At T1, patients undergoing PT had a higher probability to reach CRR (Odds Ratio = 2.6 95% CI 1.3-5.6, p = 0.01). Nabiximols was discontinued in 30/290 (10.3%) patients at T1 (early discontinuers) and in 71/290 (24.5%) patients at T2 (late discontinuers). The probability of being late discontinuers was reduced in patients undergoing PT (Hazard Ratio = 0.41; 95% CI 0.23-0.69, p = 0.001).
Our real-life study confirms nabiximols' effectiveness in MS-related spasticity and suggests that the association of a PT program may improve overall response and persistence to nabiximols treatment. |
| doi_str_mv | 10.1371/journal.pone.0219670 |
| format | Article |
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To examine the impact of physiotherapy (PT) programs on effectiveness and persistence of nabiximols treatment in people with MS-related spasticity.
This is an observational multicenter study with a follow-up period of 12 weeks, conducted in routine care settings in Italy. Patients with moderate to severe MS-related spasticity who started nabiximols were included. Spasticity was evaluated by the patient-rated 0-10 numerical rating scale (NRS). Clinical data were collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) months after enrollment.
A total of 297 MS patients were selected, 290 completed the 3 months follow-up period. Mean NRS scores were 7.6 ± 1.1 at T0, 5.8 ± 1.4 at T1 and 5.5 ± 1.5 at T2. At T1, 77% of patients reached ≥20% improvement (initial response, IR); 22% reached ≥30% improvement (clinically relevant response, CRR). At T1, patients undergoing PT had a higher probability to reach CRR (Odds Ratio = 2.6 95% CI 1.3-5.6, p = 0.01). Nabiximols was discontinued in 30/290 (10.3%) patients at T1 (early discontinuers) and in 71/290 (24.5%) patients at T2 (late discontinuers). The probability of being late discontinuers was reduced in patients undergoing PT (Hazard Ratio = 0.41; 95% CI 0.23-0.69, p = 0.001).
Our real-life study confirms nabiximols' effectiveness in MS-related spasticity and suggests that the association of a PT program may improve overall response and persistence to nabiximols treatment.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0219670</identifier><identifier>PMID: 31361750</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Biology and Life Sciences ; Botulinum toxin ; Cannabidiol - therapeutic use ; Care and treatment ; Chi-square test ; Clinical medicine ; Combined Modality Therapy ; Diagnosis ; Dronabinol - therapeutic use ; Drug Combinations ; Exercise ; Female ; Follow-Up Studies ; Humans ; Male ; Marijuana ; Medicine and Health Sciences ; Middle Aged ; Multiple sclerosis ; Multiple Sclerosis - complications ; Multiple Sclerosis - drug therapy ; Multiple Sclerosis - therapy ; Muscle Spasticity - complications ; Muscle Spasticity - drug therapy ; Muscle Spasticity - therapy ; Neurosciences ; Observational studies ; Oral Sprays ; Patients ; People and places ; Physical fitness ; Physical Sciences ; Physical therapy ; Physical Therapy Modalities ; Research and Analysis Methods ; Spasticity ; Studies ; Systematic review ; Tizanidine ; Withholding Treatment</subject><ispartof>PloS one, 2019-07, Vol.14 (7), p.e0219670-e0219670</ispartof><rights>COPYRIGHT 2019 Public Library of Science</rights><rights>2019 Grimaldi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2019 Grimaldi et al 2019 Grimaldi et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-67ed4179d7ee4a276f762552a918891c17f587a6f26842b82c041c14a6db2ba13</citedby><cites>FETCH-LOGICAL-c692t-67ed4179d7ee4a276f762552a918891c17f587a6f26842b82c041c14a6db2ba13</cites><orcidid>0000-0002-7856-0126</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6667203/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6667203/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793,79600,79601</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31361750$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Aktas, Orhan</contributor><creatorcontrib>Grimaldi, Alessandro Enrico</creatorcontrib><creatorcontrib>De Giglio, Laura</creatorcontrib><creatorcontrib>Haggiag, Shalom</creatorcontrib><creatorcontrib>Bianco, Assunta</creatorcontrib><creatorcontrib>Cortese, Antonio</creatorcontrib><creatorcontrib>Crisafulli, Sebastiano Giuseppe</creatorcontrib><creatorcontrib>Monteleone, Fabrizia</creatorcontrib><creatorcontrib>Marfia, Gerola</creatorcontrib><creatorcontrib>Prosperini, Luca</creatorcontrib><creatorcontrib>Galgani, Simonetta</creatorcontrib><creatorcontrib>Mirabella, Massimiliano</creatorcontrib><creatorcontrib>Centonze, Diego</creatorcontrib><creatorcontrib>Pozzilli, Carlo</creatorcontrib><creatorcontrib>Castelli, Letizia</creatorcontrib><title>The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray)</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Nabiximols (THC/CBD Oromucosal Spray, Sativex) is used as an add-on therapy to treat moderate to severe spasticity of Multiple Sclerosis (MS).
To examine the impact of physiotherapy (PT) programs on effectiveness and persistence of nabiximols treatment in people with MS-related spasticity.
This is an observational multicenter study with a follow-up period of 12 weeks, conducted in routine care settings in Italy. Patients with moderate to severe MS-related spasticity who started nabiximols were included. Spasticity was evaluated by the patient-rated 0-10 numerical rating scale (NRS). Clinical data were collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) months after enrollment.
A total of 297 MS patients were selected, 290 completed the 3 months follow-up period. Mean NRS scores were 7.6 ± 1.1 at T0, 5.8 ± 1.4 at T1 and 5.5 ± 1.5 at T2. At T1, 77% of patients reached ≥20% improvement (initial response, IR); 22% reached ≥30% improvement (clinically relevant response, CRR). At T1, patients undergoing PT had a higher probability to reach CRR (Odds Ratio = 2.6 95% CI 1.3-5.6, p = 0.01). Nabiximols was discontinued in 30/290 (10.3%) patients at T1 (early discontinuers) and in 71/290 (24.5%) patients at T2 (late discontinuers). The probability of being late discontinuers was reduced in patients undergoing PT (Hazard Ratio = 0.41; 95% CI 0.23-0.69, p = 0.001).
Our real-life study confirms nabiximols' effectiveness in MS-related spasticity and suggests that the association of a PT program may improve overall response and persistence to nabiximols treatment.</description><subject>Biology and Life Sciences</subject><subject>Botulinum toxin</subject><subject>Cannabidiol - therapeutic use</subject><subject>Care and treatment</subject><subject>Chi-square test</subject><subject>Clinical medicine</subject><subject>Combined Modality Therapy</subject><subject>Diagnosis</subject><subject>Dronabinol - therapeutic use</subject><subject>Drug Combinations</subject><subject>Exercise</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Male</subject><subject>Marijuana</subject><subject>Medicine and Health Sciences</subject><subject>Middle Aged</subject><subject>Multiple sclerosis</subject><subject>Multiple Sclerosis - complications</subject><subject>Multiple Sclerosis - drug therapy</subject><subject>Multiple Sclerosis - therapy</subject><subject>Muscle Spasticity - complications</subject><subject>Muscle Spasticity - drug therapy</subject><subject>Muscle Spasticity - therapy</subject><subject>Neurosciences</subject><subject>Observational studies</subject><subject>Oral Sprays</subject><subject>Patients</subject><subject>People and places</subject><subject>Physical fitness</subject><subject>Physical Sciences</subject><subject>Physical therapy</subject><subject>Physical Therapy Modalities</subject><subject>Research and Analysis Methods</subject><subject>Spasticity</subject><subject>Studies</subject><subject>Systematic review</subject><subject>Tizanidine</subject><subject>Withholding 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Collection</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Grimaldi, Alessandro Enrico</au><au>De Giglio, Laura</au><au>Haggiag, Shalom</au><au>Bianco, Assunta</au><au>Cortese, Antonio</au><au>Crisafulli, Sebastiano Giuseppe</au><au>Monteleone, Fabrizia</au><au>Marfia, Gerola</au><au>Prosperini, Luca</au><au>Galgani, Simonetta</au><au>Mirabella, Massimiliano</au><au>Centonze, Diego</au><au>Pozzilli, Carlo</au><au>Castelli, Letizia</au><au>Aktas, Orhan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray)</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2019-07-30</date><risdate>2019</risdate><volume>14</volume><issue>7</issue><spage>e0219670</spage><epage>e0219670</epage><pages>e0219670-e0219670</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Nabiximols (THC/CBD Oromucosal Spray, Sativex) is used as an add-on therapy to treat moderate to severe spasticity of Multiple Sclerosis (MS).
To examine the impact of physiotherapy (PT) programs on effectiveness and persistence of nabiximols treatment in people with MS-related spasticity.
This is an observational multicenter study with a follow-up period of 12 weeks, conducted in routine care settings in Italy. Patients with moderate to severe MS-related spasticity who started nabiximols were included. Spasticity was evaluated by the patient-rated 0-10 numerical rating scale (NRS). Clinical data were collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) months after enrollment.
A total of 297 MS patients were selected, 290 completed the 3 months follow-up period. Mean NRS scores were 7.6 ± 1.1 at T0, 5.8 ± 1.4 at T1 and 5.5 ± 1.5 at T2. At T1, 77% of patients reached ≥20% improvement (initial response, IR); 22% reached ≥30% improvement (clinically relevant response, CRR). At T1, patients undergoing PT had a higher probability to reach CRR (Odds Ratio = 2.6 95% CI 1.3-5.6, p = 0.01). Nabiximols was discontinued in 30/290 (10.3%) patients at T1 (early discontinuers) and in 71/290 (24.5%) patients at T2 (late discontinuers). The probability of being late discontinuers was reduced in patients undergoing PT (Hazard Ratio = 0.41; 95% CI 0.23-0.69, p = 0.001).
Our real-life study confirms nabiximols' effectiveness in MS-related spasticity and suggests that the association of a PT program may improve overall response and persistence to nabiximols treatment.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>31361750</pmid><doi>10.1371/journal.pone.0219670</doi><tpages>e0219670</tpages><orcidid>https://orcid.org/0000-0002-7856-0126</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2019-07, Vol.14 (7), p.e0219670-e0219670 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2266999397 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Biology and Life Sciences Botulinum toxin Cannabidiol - therapeutic use Care and treatment Chi-square test Clinical medicine Combined Modality Therapy Diagnosis Dronabinol - therapeutic use Drug Combinations Exercise Female Follow-Up Studies Humans Male Marijuana Medicine and Health Sciences Middle Aged Multiple sclerosis Multiple Sclerosis - complications Multiple Sclerosis - drug therapy Multiple Sclerosis - therapy Muscle Spasticity - complications Muscle Spasticity - drug therapy Muscle Spasticity - therapy Neurosciences Observational studies Oral Sprays Patients People and places Physical fitness Physical Sciences Physical therapy Physical Therapy Modalities Research and Analysis Methods Spasticity Studies Systematic review Tizanidine Withholding Treatment |
| title | The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray) |
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