Baricitinib as monotherapy for treatment of rheumatoid arthritis: analysis of real-world data

Current Medical Research and Opinion 2024;40:1993–2002 doi: 10.1080/03007995.2024.2416979.

Edwards et al. report on real-world data for baricitinib monotherapy in rheumatoid arthritis, showing significant disease activity reduction across multiple registries and observational studies. These findings reinforce the viability of baricitinib monotherapy in clinical practice for RA patients, complementing existing guidelines.

October 2024

Buch et al. demonstrated that filgotinib sustained its efficacy in rheumatoid arthritis patients through Wk156 in the FINCH 4 long-term extension study, showing stable safety profiles. The study reported high ACR response rates and remission based on Boolean criteria, underlining filgotinib's potential for extended clinical benefits.

September 2024

Tanaka et al. observed that in Japanese patients with rheumatoid arthritis treated with tofacitinib, those with absolute lymphocyte counts (ALCs) <0.5x10³ cells/mm³ had a higher risk of serious infections and herpes zoster events compared to patients with higher ALC levels. This threshold may help identify increased infection risk in this population

July 2024

van Vollenhoven et al. compared the efficacy and safety of upadacitinib monotherapy to methotrexate monotherapy over five years in methotrexate-naïve patients with rheumatoid arthritis. The study found that upadacitinib provided better long-term efficacy and higher rates of disease activity remission than methotrexate; however, it was associated with higher incidences of adverse events, particularly at the higher dose of 30 mg.

Patients classified as having a high neutrophil-to-lymphocyte ratio (NLR-High) who received filgotinib 200mg + MTX/csDMARDs exhibited consistently better responses after 12 weeks across clinical trials, clinical endpoints, and PROs, compared with NLR-Low patients. Taylor et al. analysed data from the 3 FINCH trials to investigate the potential association of baseline NLR with improved clinical response to filgotinib in MTX-naïve or MTX-experienced RA populations.

April 2024

Burmester, et al. found that long-term filgotinib exposure was well tolerated in patients with moderate-to-severe active RA, with a stable rate of TEAEs over time. However, potential dose-dependent relationships for herpes zoster infections, malignancies and all-cause mortality were observed in patients aged ≥65 years, indicating the potential impact of age on the safety profile of Filgotinib. Therefore, some patients aged ≥65 years may benefit from the filgotinib 100 mg dose option.

January 2024

This pooled analysis of four Phase 3 RCTs investigated the long-term efficacy baricitinib in patients with active RA who were MTX-IR, csDMARD-IR, or bDMARD-IR. They found that baricitinib demonstrated efficacy up to 6.5 years and was well tolerated.

December 2023

Rates of malignancy were similar between upadacitinib, adalimumab, and MTX. They were also consistent across RA, PsA, AS and nr-axSpA. A dose-dependent increased rate of NMSC was observed with upadacitinib in RA. For RA and PsA, being older (≥65 years) and male was associated with
an increased risk of malignancy excluding NMSC.

September 2023

Fleischmann, et al investigated the safety and efficacy of otilimab versus tofacitinib and placebo in RA patients treated with MTX (contRAst 1) or csDMARDs (contRAst 2). They found that while otilimab achieved the primary endpoint of ACR20 versus placebo in Week 12, it did not demonstrate non-inferiority to tofacitinib.

The ContRAst 3 study investigated otilimab, in RA patients with inadequate responses to multiple treatments. Otilimab did not significantly improve ACR20 versus placebo at Weeks 12 or 24. In addition, there we no significant improvements in secondary endpoints, including disease activity, disability, and pain.

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