Monotherapy with THC/CBD Spray in Multiple Sclerosis Induced Spasticity (P7.249)

Abstract

OBJECTIVE: THC/CBD spray is approved for add-on therapy in multiple sclerosis (MS) induced spasticity. In this observational study we proved efficacy and side effects of a monotherapy in a clinical setting. BACKGROUND: Pivotal trial data suggested a 30% - benefit measured by a numeric rating scale (NRS) with mean intake of 8 sprays/day. The responder rate to THC/CBD was about 51% of treated patients. DESIGN/METHODS: In all MS patients treated with THC/CBD monotherapy from Sept 2011 to June 2013 Expanded disability status scale (EDSS), Ashworth scale (AS) of the upper (UE) and lower extremities (LE) and minimal muscle strength (MMS) of UE and LE were documented before treatment. NRS dosages, side effects and drop-outs with THC/CBD were analyzed. RESULTS: In 37 patients THC/CBD monotherapy was started in 37 MS patients. Mean NRS of the 28 responder was 6.9 before and 3.4 with THC/CBD, mean dosage was 4.2 sprays/day. The AS was 0.5 of the UE and 2.0 of the LE, EDSS was 6.9, MMS was 3.2 (UE) and 1.6 (LE). The 9 non-responder reported an NRS of 6.4 before and 5.4 with THC/CBD, showed an AS of 0.9 (UE) and 2.7 (LE), EDSS of 6.4, MMS of 3.4 (UE) and 1.8 (LE). Non-responder stopped because of unsatisfied efficacy (4), incontinence (1), fatigue (1), oral discomfort (2), increasing weakness (1). CONCLUSIONS: In our observational study of THC/CBD monotherapy, due to not tolerable side effects under previously given antispastic drugs a high responder rate of 76% was found. Four patients (11%) stopped treatment because of adverse events. The efficacy, measured by NRS showed a 51% reduction with a mean dosage of 4.2 sprays/day without increased weakness. The four patients who had no sufficient efficacy did not titrate dosages up to 12 sprays because of side effects. In our study THC/CBD monotherapy was well tolerated and showed a high responder rate. Further studies should be done to validate our findings.

Disclosure: Dr. Koehler has received personal compensation for activities with Almirall Hermal, Bayer Pharmaceuticals Corp., Biogen Idec, Genzyme Corp., Merck Serono, Novartis, Sanofi-Aventis Pharmaceuticals, Inc., and Teva Neuroscience. Dr. Poellmann has nothing to disclose. Dr. Feneberg has nothing to disclose. Dr. Meier has nothing to disclose.