Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis

Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22.


Objective: Baricitinib is an orally administered inhibitor of JAK1 and JAK2 that has been shown to be effective in treating rheumatoid arthritis (RA). This study was undertaken to analyze changes in lymphocyte cell subsets during baricitinib treatment and to correlate these changes with clinical outcomes.

Methods: An integrated analysis was conducted by pooling data from 3 completed phase III trials comparing placebo with baricitinib treatment (RA-BEAM, RA-BUILD, and RA-BEACON) and 1 ongoing long-term extension study (RA-BEYOND) in patients with active RA (n = 2,186).

Results: Baricitinib treatment was associated with an early transient increase in total lymphocyte count at week 4, which returned to baseline by week 12. Transient changes within normal reference ranges in T cells and subsets were observed with baricitinib treatment, up to week 104. B cells and relevant subpopulations increased after 4 weeks of baricitinib treatment, with no further increases noted through 104 weeks of treatment. Natural killer (NK) cells temporarily increased after 4 weeks of baricitinib treatment, before decreasing below baseline levels and then stabilizing over time. With baricitinib treatment, few correlations were observed between changes in lymphocyte subsets and clinical end points, and most correlations were also observed within the placebo group. A modest potential association between low NK cell numbers and treatment-emergent infections was observed in the baricitinib 4 mg/day treatment group, but not for serious infections or herpes zoster.

Conclusion: Overall, these findings demonstrate that changes in lymphocyte subsets were largely within normal reference ranges across the baricitinib phase III RA clinical program and were not associated with increased risk of serious infections.

Trial registration: NCT01710358 NCT01721057 NCT01721044 NCT01885078.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adalimumab / pharmacology
  • Adult
  • Antirheumatic Agents / pharmacology*
  • Arthritis, Rheumatoid / blood
  • Arthritis, Rheumatoid / drug therapy*
  • Azetidines / pharmacology*
  • Clinical Trials, Phase III as Topic
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Lymphocyte Count
  • Lymphocyte Subsets / drug effects*
  • Male
  • Middle Aged
  • Purines
  • Pyrazoles
  • Randomized Controlled Trials as Topic
  • Sulfonamides / pharmacology*
  • Treatment Outcome


  • Antirheumatic Agents
  • Azetidines
  • Purines
  • Pyrazoles
  • Sulfonamides
  • Adalimumab
  • baricitinib

Associated data