Real‐life use of oral disease‐modifying treatments in Austria

Abstract

Objectives To compare the efficacy, frequencies and reasons for treatment interruption of fingolimod, dimethyl fumarate (DMF) or teriflunomide in a nationwide observational cohort using prospectively collected data. Materials and methods Two cohorts of patients with relapsing‐remitting multiple sclerosis (RRMS) starting treatment with fingolimod, dimethyl fumarate or teriflunomide documented in the Austrian MS Treatment Registry (AMSTR) since 2014 and either staying on therapy for at least 12 months (12m cohort) or having at least one follow‐up visit (total cohort). The 12m cohort included 664 RRMS patients: 315 in the fingolimod, 232 in the DMF and 117 in the teriflunomide group. Multinomial propensity scores were used for inverse probability weighting to correct for the bias of this non‐randomised registry study. Results Estimated mean annualized relapse rates (ARR) over 12 months were 0.21 for fingolimod, 0.20 for DMF and 0.19 for teriflunomide treatment, causing an incidence rate ratio (IRR) of 1.01 for fingolimod vs DMF (P = 0.96) and 0.92 for teriflunomide vs DMF (P = 0.84). No differences were found regarding the probability for experiencing a relapse, EDSS change, EDSS progression and EDSS regression, except regarding less sustained EDSS progression for 12 weeks concerning DMF vs fingolimod (P = 0.02). The hazard ratio for treatment interruption comparing fingolimod vs DMF was 1.03 (P = 0.86) and 1.07 comparing teriflunomide vs DMF (P = 0.77). Conclusions In the AMSTR, there was no difference concerning ARR, probability for a relapse, EDSS change, treatment interruption, EDSS progression or regression between oral DMTs, except regarding less sustained EDSS progression for 12 weeks concerning DMF vs fingolimod.

Oral therapies for treatment of relapsing–remitting multiple sclerosis in Austria: a 2-year comparison using an inverse probability weighting method

“…Comparing our present results with prior published 12 months' data [20], we found a significantly higher EDSS impairment, lower EDSS regression and a higher interruption rate in the TERI group. The longer observation period on treatment (at least 24 months) produced more robust data especially in regards to disease progression and regression.…”

“…The Austrian MS Treatment Registry (AMSTR) [20,21], established in 2006 to maintain quality control and comply with reimbursement regulations of the Austrian sick funds, allows to obtain clinical data, to assess indications, the clinical profiles of the treated patients and to monitor safety in real life. The AMSTR is part of the dense MS network in Austria, which is constituted by all MS clinics from neurological departments and some dedicated neurological doctoral offices.…”

“…Studies matching the clinical efficacy provided conflicting results [9][10][11][12][13][14][15][16][17][18][19][20]. These discrepancies ask for further investigations to confirm or rebut the published findings, especially by real-life experiences.…”

Pregnancy Outcomes in Patients With Multiple Sclerosis Exposed to Natalizumab—A Retrospective Analysis From the Austrian Multiple Sclerosis Treatment Registry

“…The AMSTR had been established in 2006 as part of MS network activities in Austria, consisting of all MS clinics and some specially qualified neurological practices (“MS-centres,” in total comprising ~4,300 patients). It maintains quality control and compliance with reimbursement regulations including treatment indications of the Austrian sick funds and contains the clinical profiles of the included patients and MRI and safety data ( 11 – 13 ). In Austria, prescriptions of disease-modifying therapies (DMTs) for MS are exclusively reserved for MS centers.…”

Multiple sclerosis

“…Teriflunomide and fingolimod provide oral options but differ in their efficacy, safety, and side effect profiles (Table 4). 17-29 While teriflunomide does have a risk of some worrisome side effects, (eg, hepatotoxicity, leukopenia, paresthesia), overall it has demonstrated similar or better tolerability compared to other oral DMTs in observational studies 30,31. The most important clinical risks with teriflunomide include hepatotoxicity (managed with routine laboratory monitoring), and teratogenicity.…”