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01 Dec 2020
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Fingolimod 0.5 mg an optimal therapy for relapsing-remitting MS

Audrey Abella
16 Oct 2020

The 0.5-mg dose of fingolimod has a superior benefit-risk profile over the 0.25-mg dose, and was superior to glatiramer acetate (GA) – a widely used, effective drug for multiple sclerosis (MS), for treating adults with relapsing or remitting forms of MS (RRMS), the ASSESS study has shown.

“Fingolimod 0.5 mg therapy met the primary objective of significantly reducing the rate of relapse over 12 months compared with GA therapy,” said the researchers. This was accompanied by greater improvements in several MRI parameters, they added.

Fingolimod 0.5 mg is the first oral disease-modifying therapy approved for RRMS. Evidence shows that annualized relapse rates (ARRs) dropped up to 55 percent with fingolimod 5, 1.25, and 0.5 mg vs interferon or placebo. [N Engl J Med 2010;362:387-401; Lancet Neurol 2014;13:545-556] “[However,] a dose lower than 0.5 mg could be efficacious [and] might have fewer adverse effects than the 0.5-mg dose,” they pointed out.

The team sought to evaluate the efficacy and safety of fingolimod 0.25 mg for RRMS to address the post-approval commitment with the US FDA. A total of 1,064 participants (mean age 40 years, 74 percent women) were randomized 1:1:1 to receive fingolimod 0.5 or 0.25 mg orally QD, or GA 20 mg SC QD, for 12 months. The two fingolimod doses were assessed against GA hierarchically through a step-down* procedure. [JAMA Neurol 2020;doi:10.1001/jamaneurol.2020.2950]

A 41-percent relative reduction in aggregate ARR was seen with fingolimod 0.5 mg vs GA (ARR, 0.15 vs 0.26; p=0.01). With fingolimod 0.25 mg, there was only a 15-percent relative ARR reduction vs GA, which did not reach statistical significance (ARR, 0.22 vs 0.26; p=0.42).

Compared with GA, both fingolimod doses led to fewer new or newly enlarging T2 lesions (mean, 2.6 [0.5 mg] and 3.3 [0.25 mg] vs 5.7; p<0.001 for both) and gadolinium-enhancing (GE) T1 lesions (mean, 0.4 [both fingolimod doses] vs 0.9).

A substantially higher percentage of participants had no new or newly enlarging T2 lesions with both fingolimod doses vs GA (n=156 [0.5 mg] and 155 [0.25 mg] vs 96; p<0.001 for both). A significantly greater fraction of participants were also free from GE T1 lesions with fingolimod 0.5 mg vs GA (n=261 vs 202; p=0.004).

All treatments had no effect on brain volume, given the similar percent changes from baseline brain volume across the study arms (mean, –0.65, –0.64, and –0.56 for fingolimod 0.5 mg, fingolimod 0.25 mg, and GA, respectively). These results dispute those of other studies showing reductions in the rate of brain volume loss with fingolimod vs interferon and placebo, noted the researchers.

Adverse event (AE) rates were similar across study arms (90 percent [fingolimod 0.5 mg], 88 percent [fingolimod 0.25 mg], and 87 percent [GA]). AEs leading to study drug discontinuation were more frequent with GA (14 percent) vs the two fingolimod doses (9 percent [0.5 mg] and 7 percent [0.25 mg]). “[T]he safety profile observed with both [fingolimod] doses was consistent with the profiles observed in other clinical trials of fingolimod 0.5 mg,” said the researchers.

These findings support those of a previous study reflecting the superiority of fingolimod 0.5 mg to frequently used injectable therapies such as IM interferon beta-1a. [N Engl J Med 2010;362:402-415] The more significant effects with fingolimod 0.5 mg in the current study underscore its potential as the optimal efficacious dose of fingolimod in this patient setting, they added.

 

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Most Read Articles
01 Dec 2020
Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, pertussis toxoid 2.5 mcg, filamentous haemagglutinin 5 mcg, fimbriae types 2 and 3 5 mcg, pertactin 3 mcg
Dr. Hsu Li Yang, Dr. Tan Thuan Tong, Dr. Andrea Kwa, 08 Jan 2021
Antimicrobial resistance has become increasingly dire as the rapid emergence of drug resistance, especially gram-negative pathogens, has outpaced the development of new antibiotics. At a recent virtual symposium, Dr Hsu Li Yang, Vice Dean (Global Health) and Programme Leader (Infectious Diseases), NUS Saw Swee Hock School of Public Health, presented epidemiological data on multidrug-resistant (MDR) gram-negative bacteria (GNB) in Asia, while Dr Tan Thuan Tong, Head and Senior Consultant, Department of Infectious Diseases, Singapore General Hospital (SGH), focused on the role of ceftazidime-avibactam in MDR GNB infections. Dr Andrea Kwa, Assistant Director of Research, Department of Pharmacy, SGH, joined the panel in an interactive fireside chat, to discuss challenges, practical considerations, and solutions in MDR gram-negative infections. This Pfizer-sponsored symposium was chaired by Dr Ng Shin Yi, Head and Senior Consultant of Surgical Intensive Care, SGH.
Pearl Toh, 26 Nov 2020
Inhaled corticosteroid (ICS) should be the mainstay of long-term asthma management — such is the key message of the latest Singapore ACE* Clinical Guidance (ACG) for asthma, released in October 2020.
3 days ago
Daily intake of cow’s milk formula in early life helps prevent the development of cow’s milk allergy later on without competing with breastfeeding, a recent study has found.