Retrospective evaluation of the effectiveness of fingolimod treatment on clinical and MR imaging in patients with relapsing remitting multiple sclerosis

Dr. Hande BALTACI

Retrospective evaluation of the effectiveness of fingolimod treatment on clinical and MR imaging in patients with relapsing remitting multiple sclerosis

Thesis Type: Expertise In Medicine

Institution Of The Thesis: Gazi University, Tıp Fakültesi, Turkey

Approval Date: 2020

Thesis Language: Turkish

Student: Dr. Hande BALTACI

Supervisor: EMİNE BELGİN KOÇER

Open Archive Collection: AVESIS Open Access Collection

Abstract:

There are variable disease modifying and immunsuppressive drugs which have different action mechanisms for Multiple Sclerosis. Fingolimod is the first oral medication that is approved for second line treatment in RRMS patients and also can be used as a first line treatment in highly active RRMS patients in Turkey. Fingolimod is a safe and effective drug demonstrated by randomized controlled trials and real world studies. In our study, 59 MS patients who used fingolimod 1 year to 8 years were analyzed retrospectively. Effects of fingolimod on annualized relaps rates, new/enlarging MRI lesions, disability progression and NEDA-3 sustainability were investigated. The reasons for switching to fingolimod, permanent and temporary discontinuations were discussed; persistence with fingolimod and adverse events were noted. The experiences gained from using fingolimod in our clinic have been shared and some important events have been explained over individual patients. It was found that fingolimod had favorable effects on disease activity (MRI lesions and relapses) and provided stable EDSS scores in years independent of age, sex and previus disease modifying threapies, in line with the literature. Annualized relapse rates decreased by 86% compared to baseline and this effect continued in the ongoing years. EDSS remained ≤ 2,5 in 66,7% of patients after four years. The proportion of patients who can sustain NEDA-3 in the first year of treatment is 46,3%; it is 42,3% and 23,5% for the 2nd and 3rd years, respectively. However, demographic features and disease characteristics were not found to be associated to these favorable effects of fingolimod. Only higher baseline relaps rates was found to be associated to lower rates of sustained NEDA-3. Ninety one percent of patients remained in treatment at the end of the first year, this rate was 82.9% at the end of 2 years and 92.3% at the end of three year. None of the patiens using fingolimod has had serius side effects. One patient had VZV infection but easily treated with anti viral theraphy. There were cases when the drug was discontinued temporarily. Twent seven percent of patients requiered to discontinuation of fingolimod permanently. After discontinuation the drug for a pregnancy plan, one patient developed serious MRI activity which responded well to steroids. It is important to inform patients about disease reactivation that may develop after drug discontinuation. In our study, the reason for the lack of statistically significant results in subgroups of effects of fingolimod in the sustainability of NEDA-3 and relapses may be related to the small number of patients and the heterogeneous disease characteristics of these patients. In conclusion, in the majority of patients, fingolimod has positive effects on clinical and MRI and its safety profile is quite good in this single-center retrospective study. The results of the study provide information to identify the subgroups of patients who can benefit from the treatment at a better rate.