Wednesday, 29 June 2016

Use of Off label Drugs in Italian Centres

D'Amico et al. The Use of Immunosuppressant Therapy for Multiple Sclerosis in Italy: A Multicenter Retroprospective Study. PLoS One. 2016; 11(6):e0157721.

INTRODUCTION: Immunosuppressive agents (ISA) have been used in multiple sclerosis (MS) for decades, frequently as off label licensed therapies. Given the new MS treatment landscape, what place do ISA have in combating MS?

METHODS: We conducted a retrospective multicentre study to investigate the frequency of ISA prescription in 17 Italian MS centres, and to describe the clinical factors related to ISA use.


RESULTS: Out of 6,447 MS patients, 2,034 (31.6%) were treated with ISA, with Azathioprine being the most frequently used ISA overall. MS patients treated with ISA alone were more frequently affected by the progressive course (both primary and secondary) of the disease (RRR 5.82, 95% CI 4.14-8.16, p<0.0001), had higher EDSS (RRR 3.69, 95% CI 2.61-5.21, p<0.0001), higher assignment age (RRR 1.04, 95% CI 1.03-1.06, p<0.0001) than patients treated with only disease modifying drugs (DMDs).


CONCLUSIONS: Progressive course, higher EDSS, higher assignment age were the strongest predictors of ISA prescription and use in our population.



You can read the paper.
6,447 patients were analysed. A number of 4,413 (68.4%) were treated with DMDs (INFs or GA) and 2,034 (31.6%) with ISA. Out of 2,034 ISA treated patients, AZA was the most frequently used in monotherapy (41.4%), followed by mitoxantrone (24,4%), then cyclophophamide (7.9%) and Methotrexate (4.4%). The 21.9% of the whole group assigned to ISA treatment had used more than one single ISA drug

DrK has been banging on about use of generic cladribine, but how many neuros in UK would use off-label DMT?  

However, maybe he is wasting his time with the Brits and maybe he should be talking to his Italian Colleagues. Based on this post it is clear that neuros in Italy are willing to try off label drugs as they are prescribing Azathioprine and other unlicenced drugs. However based on results recently published it would seem that azathioprine is being used, 



Based on the data above,  azathioprine  is in the league of the interferons, so  is not going to be as good a NEDA inducing drug as cladribine. So would Italian Neuros try something that may be more active.

However when the off label drugs are being applied they are being used in people with progressive MS and so one would think they are going to have no/modest activity. 

Remember what ever you take you need to be NEDA have you read  http://www.msbrainhealth.org/

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