Baricitinib maintains consistent safety profile in long-term study in patients with rheumatoid arthritis

By Samar Mahmoud, MS
Published February 20, 2022

Key Takeaways

  • This integrated safety analysis found that baricitinib maintained a consistent safety profile in patients with rheumatoid arthritis (RA). 

  • This study included long-term data on patients treated with baricitinib and will be helpful in guiding treatment choices for patients with active RA.

RA is a chronic, inflammatory disease that can be effectively managed with long-term treatment options.

Why This Study Matters 

Baricitinib , an oral Janus kinase inhibitor, is approved for the treatment of adults with moderate-to-severe active RA. While previous safety trials have indicated that Baricitinib is safe, long-term data for long-term baricitinib use is needed. To address this need, this study sought to conduct an integrated analysis on patients with active RA, with a median follow-up period of 4.6 years.

Study Design 

This study consisted of a pooled analysis of 9 phase III/II/Ib studies and 1 long-term extension study of patients who received any baricitinib dose. Investigators estimated standardized incidence ratios for malignancy (excluding non-melanoma skin cancer) and standardized mortality ratios. An additional analysis was performed on a subset of patients who had ever taken 2 mg or 4 mg baricitinib.

Results and Conclusions

The study included 3770 patients who received baricitinib. For patients who received any baricitinib dose, the incidence rate of adverse events per 100 patient years of exposure were 2.6, 3.0 and 0.5 for serious infections, herpes zoster, and major adverse cardiovascular events (MACE), respectively.

The incidence rate for malignancy during the first 48 weeks was 0.6, remaining stable thereafter. Investigators did not observe any dose-dependent differences for exposure-adjusted incidence rates for deaths, serious infections, DVT/PE, and MACE. 

Related Research

Consider these findings from similar research studies:

  • Baricitinib once a day inhibits joint damage progression in patients with moderate-to-severe RA who are naive disease-modifying antirheumatic drugs (Source). 

  • Baricitinib treatment was effective and well-tolerated for up to 3 years in patients with active RA (Source).

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