Safety and efficacy of Filgotinib in patients aged 65 years and older: results from a phase 3 study in patients with active rheumatoid arthritis and prior inadequate response or intolerance to biological DMARDS (bDMARDS-IR).
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Authors
Walker, David
Issue Date
2019
Type
Article
Language
en
Keywords
Rheumatoid arthritis (RA) , Filgotinib
Alternative Title
Abstract
Background: Filgotinib (FIL), an oral selective Janus kinase 1 (JAK1) inhibitor, demonstrated efficacy and safety vs placebo (PBO) in bDMARD-IR patients with active RA in a global phase 3 study (FINCH2, ClinicalTrials.gov NCT02873936).1
Objectives: We performed a prespecified subgroup analysis of the safety and efficacy of FIL in patients aged ≥65 years vs <65 years in FINCH2 to understand FIL effects in older patients.
Methods: 449 patients were randomized 1:1:1 to FIL 200 mg, FIL 100 mg, or PBO on a background of csDMARDs for 24 weeks. The primary efficacy endpoint was ACR20 response at week 12.
Results: Of 448 patients who received ?1 dose of study drugs, 113 (25.2%) were ?65 years of age; baseline disease characteristics were similar for both age groups. Safety and efficacy parameters by age group are in Tables 1 and 2. The most common treatment-emergent adverse events (TEAEs, by System Organ Class) category was infections and infestations; nasopharyngitis, upper respiratory tract infections, and bronchitis were the most common infections and infestations in the FIL arms in both age groups. There were no cases of opportunistic infection, active tuberculosis, malignancy, gastrointestinal perforation, or death. Efficacy outcomes were similar for both groups.
Conclusion: Overall, older age was not associated with higher incidence of safety events (serious infections, herpes zoster, MACE occurred in the group <65 yrs) and efficacy was similar in older and younger bDMARD-IR patients with active RA.
Description
Citation
Kalunian, K., Gottenberg, J., Genovese, M.C. et al. (2019) FRI0154?SAFETY AND EFFICACY OF FILGOTINIB IN PATIENTS AGED 65 YEARS AND OLDER: RESULTS FROM A PHASE 3 STUDY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS AND PRIOR INADEQUATE RESPONSE OR INTOLERANCE TO BIOLOGICAL DMARDS (BDMARD-IR). Annals of the Rheumatic Diseases; 78 : 748-749.
Publisher
License
Journal
Annals of the Rheumatic Diseases
Volume
Issue
PubMed ID
ISSN
1468-2060