Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database.

Taylor, Peter C;Takeuchi, Tsutomu;Burmester, Gerd R;Durez, Patrick;Winthrop, Kevin L;et.al.
(2022) Annals of the rheumatic diseases — Vol. 81, n° 3, p. 335-343 (2022)

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  • Taylor, Peter Corcid-logo
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  • Takeuchi, Tsutomuorcid-logo
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  • Burmester, Gerd Rorcid-logo
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  • Durez, PatrickUCLouvain
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  • Winthrop, Kevin Lorcid-logo
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Abstract
(en) OBJECTIVE: To report long-term safety from the completed extension trial of baricitinib, an oral selective Janus kinase inhibitor, in patients with active rheumatoid arthritis (RA). METHODS: Treatment-emergent adverse events are summarised from an integrated database (9 phase III/II/Ib and 1 long-term extension) of patients who received any baricitinib dose (All-bari-RA). Standardised incidence ratio (SIR) for malignancy (excluding non-melanoma skin cancer (NMSC)) and standardised mortality ratio (SMR) were estimated. Additional analysis was done in a subset of patients who had ever taken 2 mg or 4 mg baricitinib. RESULTS: 3770 patients received baricitinib (14 744 patient-years of exposure (PYE)). All-bari-RA incidence rates (IRs) per 100 patient-years at risk were 2.6, 3.0 and 0.5 for serious infections, herpes zoster and major adverse cardiovascular events (MACE), respectively. In patients aged ≥50 with ≥1 cardiovascular risk factor, the IR for MACE was 0.77 (95% CI 0.56 to 1.04). The IR for malignancy (excluding NMSC) during the first 48 weeks was 0.6 and remained stable thereafter (IR 1.0). The SIR for malignancies excluding NMSC was 1.07 (95% CI 0.90 to 1.26) and the SMR was 0.74 (95% CI 0.59 to 0.92). All-bari-RA IRs for deep vein thrombosis (DVT)/pulmonary embolism (PE), DVT and PE were 0.5 (95% CI 0.38 to 0.61), 0.4 (95% CI 0.26 to 0.45) and 0.3 (95% CI 0.18 to 0.35), respectively. No clear dose differences were noted for exposure-adjusted IRs (per 100 PYE) for deaths, serious infections, DVT/PE and MACE. CONCLUSIONS: In this integrated analysis including long-term data of baricitinib from 3770 patients (median 4.6 years, up to 9.3 years) with active RA, baricitinib maintained a similar safety profile to earlier analyses. No new safety signals were identified. TRIAL REGISTRATION NUMBER: NCT01185353, NCT00902486, NCT01469013, NCT01710358, NCT02265705
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Taylor, P. C., Takeuchi, T., Burmester, G. R., Durez, P., Smolen, J. S., Deberdt, W., Issa, M., Terres, J. R., Bello, N., & Winthrop, K. L. (2022). Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Annals of the rheumatic diseases, 81(3), 335-343. https://doi.org/10.1136/annrheumdis-2021-221276 (Original work published 2022)