CRITICAL APPRAISAL OF EFFECTIVENESS OF ORAL FINGOLIMOD ON RELAPSING MULTIPLE SCLEROSIS
Abstract: Oral fingolimod has
been recently accepted as a treatment for relapsing Multiple Sclerosis (MS) by
the Indonesian Food and Drug Administration. The number of MS patients is
increasing in Indonesia. There is a critical need of systematically reviewing
the new medication for both efficacy and safety. This review aimed to appraise
the clinical evidences of oral fingolimod for the effective treatment of
relapsing MS. We searched in Pubmed database. We limited our search to only
articles that were in full text, published within the last 10 years, and in
English. We used the Jadad scale to measure the quality of the evidences. We
only found 3 trials, all conducted with randomized and double blind design. The
three trials were: the FREEDOMS I, FREEDOMS II, and TRANSFORMS studies. The
FREEDOMS studies compared with placebo, and the TRANSFORMS study compared with
injectable interferon. All of the studies have good quality in methodology
(Jadad scale >3). The results of the three studies showed the benefit of
oral fingolimod in reducing MS relapse compared with placebo with relative risk
reduction range from 48% to 54%, and also in reducing new lesions in T2 brain
MRI with relative risk reduction range from 35% to 74%. Our critical appraisal
found that oral fingolimod improved clinical outcomes. The availability of oral
fingolimod in Indonesia makes it one of the options in treatment of MS relapse
in Indonesia and has been demonstrated to be effective and safe with relatively
small risk.
Keywords: critical appraisal;
fingolimod; multiple sclerosis; relapse
Penulis: Rizaldy Taslim
Pinzon, Rosa De Lima Renita Sanyasi
Kode Jurnal: jpfarmasidd170456
