Abstract Details

Title Long-term Effectiveness of 9-d-tetrahydrocannabinol:Cannabidiol Oromucosal Spray in Clinical Practice: results from a 18-months Multicenter Italian Study

Topic Multiple Sclerosis

Presentation(s) P5 - Poster Session 5 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-085

Objective

We aimed to provide real life data on clinical outcomes of a large population of Italian patients with treatment-resistant multiple sclerosis (MS) spasticity receiving 9-δ-tetrahydocannabinol and cannabidiol (THC:CBD) oromucosal spray (Sativex®).

Background THC:CBD oromucosal spray is used as mono or add-on therapy for moderate to severe MS spasticity resistant to other medications.

Design/Methods This 18-months observational, prospective, multicentre study evaluated patients with resistant MS spasticity treated with THC:CBD according to approved labelling. Data were collected from the mandatory Italian medicines agency (AIFA) e-registry from January 2015 to June 2018. Spasticity assessment with the 0-10 numerical rating scale (NRS) was performed at baseline, after 1 month of treatment (T1) and every 6 months until 18 months (T4) from the treatment initiation.

Results A total of 1845 patients were recruited from 32 Italian MS centres. At T1, 1502 (81.4%) of patients reached an NRS improvement of ≥20% and 814 (40.2%) a of ≥30%, with a mean NRS score reduction of 28.9% at T1 and of 36.8% at T4. Daily number of puffs was generally stable through the observation period (6.9±2.4 at T1 vs 6.3±3.1 at T4, p=0.8). At T4, 727 (39.4%) patients have discontinued treatment; 388 (53.4%) because of lack of effectiveness and 339 (46.6%) for adverse events: 127 (37.5%) reported vertigo, 118 (34.8%) sleepiness, 96 (28.3%) worsening of fatigue, and 54 (15.9%) cognitive symptoms. The multivariate analysis showed that higher NRS score at baseline (OR 2.21 95%CI 1.12-6.28, p<0.01) and higher difference of NRS between T1 and baseline (OR 2.03 95%CI 1.04-8.14, p<0.05) were associated to an increased probability to stay on therapy after 18 months.

Conclusions Real-life data from a large Italian MS population confirmed the long-term effectiveness of THC:CBD for the treatment of resistant MS spasticity in everyday clinical practice. Treatment effects were sustained for 18-months with a relatively stable number of puffs/day.

Authors/Disclosures
Francesco Patti, MD PRESENTER	Dr. Patti has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. The institution of Dr. Patti has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Almirall. Dr. Patti has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Meyers. Dr. Patti has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Johnson and Johnson. The institution of Dr. Patti has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck. The institution of Dr. Patti has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Patti has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. The institution of Dr. Patti has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Patti has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion, Almirall, Bayer, Biogen, Bristol Meyers and Squibb Merck, Roche, Sanofi, TEVA. Dr. Patti has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for University of Catania and AISM/FISM, Fondazione Italiana Sclerosi Multipla. Dr. Patti has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers in Neurology.
Clara Chisari, MD	Clara Chisari, MD has nothing to disclose.
Emanuele D'Amico	Emanuele D'Amico has nothing to disclose.
Claudio Solaro, MD (Neurology PA Micone Hospital)	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Assunta Bianco	Assunta Bianco has nothing to disclose.
	No disclosure on file
Fabio Buttari	No disclosure on file
	No disclosure on file
	No disclosure on file
Raffaella Cerqua	No disclosure on file
Gianfranco Costantino, MD	No disclosure on file
Federica Esposito	Federica Esposito has received personal compensation in the range of $0-$499 for serving as a Consultant for Merck. Federica Esposito has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Federica Esposito has received personal compensation in the range of $0-$499 for serving as a Consultant for Novartis. Federica Esposito has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Federica Esposito has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. The institution of Federica Esposito has received research support from Italian MS Society. The institution of Federica Esposito has received research support from Italian Ministry of Health. The institution of Federica Esposito has received research support from ERA Net. The institution of Federica Esposito has received research support from European Commission. Federica Esposito has received intellectual property interests from a discovery or technology relating to health care.
Claudio Gasperini, MD	Dr. Gasperini has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche, Merck, Genzyme, Novartis,Bayer, Teva, Almirall.
Angelica Guareschi (Ospedale San Raffaele)	No disclosure on file
Matilde Inglese, MD, PhD (University of Genoa)	Dr. Inglese has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for SANOFI GENZYME. Dr. Inglese has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BIOGEN. Dr. Inglese has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NOVARTIS. Dr. Inglese has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for MERCK-SERONO. Dr. Inglese has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ROCHE. Dr. Inglese has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for MS Journal.
	No disclosure on file
Roberta Lanzillo	Roberta Lanzillo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck, Biogen. Roberta Lanzillo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen, Roche, Novartis.
	No disclosure on file
Manuela Matta	No disclosure on file
	No disclosure on file
	No disclosure on file
Simona Pontecorvo	No disclosure on file
	No disclosure on file
	No disclosure on file
Francesco Sacca, MD, FAAN (University Federico II)	Dr. Sacca has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion. Dr. Sacca has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Argenx. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lexeo. Dr. Sacca has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genpharm. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medpharma. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Madison Pharma. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zai Lab. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dianthus. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Reata. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neopharm Israel. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Johnson&Johnson. Dr. Sacca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Sacca has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Astrazeneca. The institution of Dr. Sacca has received research support from AIFA. The institution of Dr. Sacca has received research support from FARA.
	No disclosure on file
Elisabetta Signoriello	Elisabetta Signoriello has nothing to disclose.
Gabriella Spinicci, MD (ASL n.8 Ospedale Binaghi Centro Sclerosi Mult)	No disclosure on file
Daniele Litterio A. Spitaleri (A.O. "S. Giuseppe Moscati")	Daniele Litterio A. Spitaleri has received research support from Novartis.
Eleonora Tavazzi, MD (Instituto Mondino)	No disclosure on file
	No disclosure on file
Mauro Zaffaroni (Teva Pharma Italia)	No disclosure on file
Mario Zappia, MD (Università Degli Studi Di Catania- Dept of Medical & Surgical Sciences)	No disclosure on file

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