FDA New Drug and Biologic Approvals, 2018 Midyear Review

Mary L Windle, PharmD

Disclosures

August 01, 2018

In This Article

Rheumatoid Arthritis: Olumiant (baricitinib)

Indication: Indicated for adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

Mechanism: Janus kinases (JAKs) pathways inhibitor. JAK consists of a group of intracellular tyrosine kinases that transmit signals from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoieses and immune cell function.

Dosage: 2 mg PO once daily.

Approval was supported by the RA-BUILD, RA-BEYOND, and RA-BEACON phase III clinical trials. The RA-BUILD study was a double-blind 24-week study that included 684 biologic DMARD-naive patients with RA and inadequate response or intolerance to 1 or more conventional synthetic DMARDs. More patients achieved ACR20 response at week 12 with baricitinib 4 mg (62%) compared to placebo (39%) (P≤0.001).

The RA-BEYOND study showed that radiographic progression at 24 and 48 weeks was statistically significantly lower for baricitinib 2 or 4 mg than for placebo. However, only baricitinib 4 mg demonstrated statistically significant inhibition of progressive radiographic joint damage when compared to placebo at week 48.

In the RA-BEACON study (N=527), patients with RA received baricitinib 2 mg, baricitinib 4 mg, or placebo in addition to conventional DMARDs that they were taking. Patients in the study demonstrated an inadequate response or intolerance to at least one TNF inhibitor therapy. Study participants could have undergone prior therapy with other biological DMARDs. Patients who received baricitinib experienced significantly higher ACR20 response rates and gains in all individual ACR20 component scores at week 12. Rates of ACR20 response were significantly higher in those treated with baricitinib (49%) than those who received placebo (27%) at week 12.

References:

  • Dougados M, van der Heijde D, Chen YC, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis. 2017 Jan;76(1):88-95. https://www.ncbi.nlm.nih.gov/pubmed/27689735

  • Van der Heijde D, Dougados M, Chen YC, et al. Effects of baricitinib on radiographic progression of structural joint damage at 1 year in patients with rheumatoid arthritis and an inadequate response to conventional synthetic disease-modifying antirheumatic drugs. RMD Open. 2018 May 8;4(1). https://www.ncbi.nlm.nih.gov/pubmed/29765703

  • Smolen JS, Kremer JM, Gaich CL, et al. Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON). Ann Rheum Dis. 2017 Apr; 76(4): 694–700. https://www.ncbi.nlm.nih.gov/pubmed/27799159

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