P220 An updated safety profile of baricitinib for the treatment of RA up to 7 years
Authors: Walker David , Kouris Ilias , Holzkämper Thorsten , Wu Marco W , Xavier Ricardo , Smolen Josef , Durez Patrick , Chen Yi-Hsing , Zhong Jinglin , Liao Ran , Genovese Mark C , Winthrop Kevin 
Published: April 2020

Background

Baricitinib (BARI) is a selective inhibitor of janus kinase (JAK) 1 and JAK2, approved for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults in over 50 countries. Objective: To evaluate the long-term safety of BARI in patients with RA with a specific focus on malignancies, major adverse cardiovascular events (MACE), serious infections and herpes zoster (HZ) events.

Methods

Data from nine completed studies (5 Phase 3, 3 Phase 2, 1 Phase 1b) and 1 long term extension (LTE) study were pooled for this analysis (data cut-off date: 13-Feb-2018). The all BARI data set included all patients exposed to any BARI dose.

Results

A total of 3,770 patients with RA were treated with BARI (10,127 patient years [PY]) with a maximum exposure of 7 years. Of these, 2,938 (78%) and 1,754 (47%) were on concomitant methotrexate or corticosteroids (CS; mean dose 6.2 mg/day), respectively. The incidence rates (IR) of malignancy (excluding non-melanoma skin cancer) were 0.8 (2-mg) and 1.0 (4-mg; as-randomized analysis) in the LTE. The IRs for MACE were similar between the all BARI and PBO group; however, the IR for DVT/PE were numerically higher in the BARI 4mg group during the PBO-controlled period. IRs for MACE remain stable over time. The IR of serious infections were numerically higher in the PBO group; the IR of tuberculosis and other opportunistic infections were similar between the all BARI and PBO group. During the PBO-controlled period, HZ IR was significantly higher for BARI 4-mg versus PBO (4.4 vs 1.1) (Table 1). Amongst 323 HZ patients, 11 (4%) had received prior HZ vaccination. Twenty-six [8%] cases were multidermatomal, and no visceral disease was reported. Multivariate analyses showed that older age and some geographical regions (Asia, especially Japan, Taiwan and South Korea) were associated with a higher risk of HZ.

Conclusion

This integrated analysis in patients with active RA exposed to BARI for up to 7 years shows that the safety profile of BARI is like that reported previously. The IRs of malignancies, MACE (including DVT/PE), serious infection, and HZ did not increase over time.

Disclosures

D. Walker: Honoraria; Lilly, Pfizer, Giliad, Novartis, Roche. Member of speakers’ bureau; Lilly, Pfizer, Roche. I. Kouris: Other; Lilly employee. T. Holzkämper: Shareholder/stock ownership; Lilly. Other; Lilly employee. M.W. Wu: Other; Lilly employee. R. Xavier: None. J. Smolen: Consultancies; Abbvie, Amgen, Astra Zeneca, Astro, BMS. Grants/research support; Abbvie, Eli Lilly, Novartis, Pfizer, Roche, Samsung, Sanofi-Aventis, UCB. P. Durez: Member of speakers’ bureau; Abbvie, BMS, Celltrion, Eli Lilly. Y. Chen: None. J. Zhong: Corporate appointments; Eli Lilly Contractor. R. Liao: Other; Lilly employee. M.C. Genovese: Consultancies; Eli Lilly. K. Winthrop: Consultancies; Pfizer, UCB, Eli Lilly, Gilead, Abbvie, Roche, BMS.