Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Case-control study nested in the cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(L03AB07) interferon beta-1a
interferon beta-1a
(L03AX13) glatiramer acetate
glatiramer acetate
(L03AB08) interferon beta-1b
interferon beta-1b
(L03AB13) peginterferon beta-1a
peginterferon beta-1a
(L04AA31) teriflunomide
teriflunomide
(L04AA27) fingolimod
fingolimod
(L04AX07) dimethyl fumarate
dimethyl fumarate
(L04AA34) alemtuzumab
alemtuzumab
(L04AA23) natalizumab
natalizumab

Medical condition to be studied

Multiple sclerosis
Neoplasm malignant
Population studied

Short description of the study population

The study focused on patients with multiple sclerosis (MS), aged 18 or older, affiliated to the general scheme, diagnosed between January 2007 and December 2014, and with at least 12 months of history identified from the SNDS database.
The untreated MS sub-cohort includes patients without any disease modifying drugs (DMD) treatment or hospitalization for MS treatment administration.
The newly treated MS sub-cohort includes patients who receive their first DMD treatment or hospitalization for MS treatment.
Non-MS patients are those from the general population of the EGB database, aged 18 or older at January 2007 and without any MS diagnosis between January 2007 and December 2015.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Patients with multiple sclerosis

Estimated number of subjects

100000
Study design details

Main study objective

To estimate the incidence of any malignancies (including or excluding non-melanoma skin cancer) and by individual malignancy type, overall and stratified by age, gender and history of malignancy in:-MS patients in comparison to a sample of non-MS patients from the general population -Untreated patients of the MS cohort -Patients of the MS cohort newly treated with DMD, according to the DMD group

Outcomes

The primary outcome is defined as the first occurrence of malignancy (excluding metastasis) identified during the study period. As defined by the algorithm of the French National Health Insurance, malignancy will be identified by any hospitalization or LTD with ICD-10 codes of cancer or by any specific anti-cancer treatment dispensing, excluding cancer recurrences and secondary tumours.

Data analysis plan

-Description of MS patients, untreated and newly treated MS patients, cases and controls: demographic characteristics, MS variables at inclusion or index date as applicable, relapse, medical history, medication, healthcare consumption during the pre-inclusion or pre-initiaion period as applicable, relapse, medication, number of visits with any healthcare provider during the follow-up -Estimation of crude annual incidence rates (exact Poisson) and standardized incidence rates for all malignancies and by individual malignancy type in each cohort or sub-cohort, stratified by age, gender, history of malignancy, and according to type of IS if enough cases among the newly treated MS patients -Estimation of association between DMD exposure and risk of malignancy in the sub-cohort of newly treated MS patients (intention-to-treat, Cox proprotional hazard model after adjusting for propensity score), and among cases and controls nested in this sub-cohort (conditional logistic regression model)
Documents
Study publications
Bosco‐Lévy P, Foch C, Grelaud A, Sabidó M, Lacueille C, Jové J, Boutmy E, Blin …