A tale of two (cannabis) registries
In the last month, we have seen the almost simultaneous publication of the initial results from two different, formalized patient registries in the UK aimed at capturing real-world evidence from the use of cannabis-based medicinal products prescribed by healthcare professionals: Project Twenty21 (T21) and the UK Medical Cannabis Registry (UKMCR). Khiron Life Sciences has contributed to both registries by providing CBMP at a discounted price, thus facilitating the access of UK patients to their medicines. Interestingly, both registries used similar validated tools to measure overall health related quality-of-life (QoL), such as the Euro-Qol 5 Dimensions (EQ-5D), the Generalised Anxiety Disorder 7-Item Scale (GAD-7) and a sleep quality questionnaire. Additionally, participants were asked to complete condition-specific effectiveness measures and Patient-Reported Outcome Measures (PROMs), although these results are not yet available and, therefore, were not included in any of the peer-reviewed publications.1,2
Project T21, launched in August 2020 by the charity Drug Science, initially recruited 678 individuals with 75 of them completing the 3-month follow up by March 2021. Study demographics and experimental methods are included in the publication by Sakal and colleagues, who highlight the relatively poor health of their patient population as one of the most striking features.1 Means score of the EQ-VAS reported across the entire sample (47.3) was considerably lower than the normative value for the United Kingdom population (85.7).3 UKMCR, organized by Sapphire Clinics, the first CQC-registered Medical Cannabis Clinic in the UK, included 129 patients in the data analysis with only 50 recording PROMs at 3 months. Similarly, Erridge and colleagues report on the study demographics, but also include more granular results on changes in quality of life, generalized anxiety and sleep quality at 3 months of those 50 participants.2
|Registry||n of patients at 3-month follow-up||Primary condition Chronic pain (%)||Self-reported QOL at baseline EQ-VAS (0-100, mean ± SD)||Self-reported QOL at 3-month EQ-VAS (0-100, mean ± SD)|
|ProjectT21||75||55.6||40.7 ± 19.7||61.5 ± 18.8|
|UKMCR||50||55.3||45.4 ± 22.25||59.6 ± 25.4|
Although results are very preliminary, and it is unclear if these two patient populations are completely independent (if there are no T21 patients being prescribed CBMP at Sapphire Clinic), results from both registries seem to indicate a similar increase in self-reported quality of life in patients suffering from chronic pain and anxiety disorders as most common primary indications (see table). It will be interesting to see if in the coming months these two registries continue to offer a complementary vision of the current scenario for UK patients trying to access medical cannabis, thus building a real-world evidence base on the effectiveness of CBMPs to treat chronic conditions other than those currently approved by the National Institute for Health and Care Excellence (NICE).
1. Sakal, C., Lynskey, M., Schlag, A. K. & Nutt, D. J. Developing a real-world evidence base for prescribed cannabis in the United Kingdom: preliminary findings from Project Twenty21. Psychopharmacology (Berl). (2021) doi:10.1007/s00213-021-05855-2.
2. Erridge, S. et al. An initial analysis of the UK Medical Cannabis Registry: Outcomes analysis of first 129 patients. Neuropsychopharmacol. Reports npr2.12183 (2021) doi:10.1002/npr2.12183.
3. Janssen, M. F., Bonsel, G. J. & Luo, N. Is EQ-5D-5L Better Than EQ-5D-3L? A Head-to-Head Comparison of Descriptive Systems and Value Sets from Seven Countries. Pharmacoeconomics 36, 675–697 (2018).