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Use of sarilumab in patients
with failed TNF
inhibitors can promote long term clinical efficacy in rheumatoid arthritis.
Sarilumab (a human monoclonal antibody) has
been known to offer consistent effectiveness over a period of 5 years in
patients who had unmanagable rheumatoid arthritis (RA) with the TNF inhibitors, as
concluded from a study by Roy
Fleischmann et al.
RA patients in the 24-week TARGET trial who received placebo or
sarilumab 150 or 200 mg every 14 days, along with conventional synthetic DMARDs
(csDMARDs), were suitable to obtain a combination of sarilumab 200 mg every 14
days and csDMARDs in the long-term extension study (OLE).
Decrease of OLE dose to 150 mg every 2 weeks was in accordance with the
judgment by study investigators or protocol-mandated safety concerns.
OLE study had 454 (83%) out of
546 patients on sarilumab therapy. The cumulative study period was 1654.8
patient-years and 268 patients (51%) had an exposure of more than equal to 4
years'. Incidence rates per 100 PY of adverse effects (AEs) was 160.4,
discontinuation due to AEs was 8.1 and infection was 57.8. The most frequently observed AE was neutropenia.
Seventy four patients (14.2%) had total neutrophil count <1000 cells/mm3 and
which was controlled in 48 patients on sarilumab therapy. A follow-up of 5
years depicted a sustained clinical efficacy. Similar efficacy was witnessed in
patients who had TNFi failure, and between patients who either continued 200 mg
or decreased to 150 mg.
Rheumatology
Long-term safety and efficacy of sarilumab over 5 years in patients with rheumatoid arthritis refractory to TNF inhibitors
Roy Fleischmann et al.
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