As we move to using short-acting drugs forthe treatment of RA in the time of a pandemic, doesbaricitinib live up to its trial data in clinical practice?

ABSTRACT

Background/AimsBaricitinib is an oral, reversible and selective inhibitor of JAK1 andJAK2 tyrosine kinases. It was approved for use in 2017 by NICE for thetreatment of moderate to severe rheumatoid arthritis (RA). Consideringthe current risk of COVID-19, the BSR have advocated the use ofshort-acting drugs such as baricitinib when escalating treatment in RA.As real-world data is limited, we aimed to explore the efficacy ofbaricitinib in clinical practice.MethodsObservational data was collected retrospectively for patients at theDudley Group NHSFT with RA (ACR/EULAR criteria) who had receivedat least one dose of baricitinib prior to 1st October 2019, with a followup period to 1st October 2020. Patients were identified from a localbiologics database. Further data was identified from patients' medicalrecords including, demographics, features of RA, previous RA therapyhistory and disease activity scores (DAS28) at 0, 6 and 12 months.Data was input into an Excel spreadsheet with subsequent analysisconducted using SPSS Version26.ResultsWe identified 26 RA patients (77% female) treated with baricitinib;mean age 61.6 (SD 14.6) years and median disease duration of 12.1(IQR 5.8-18.4) years. Rheumatoid factor and anti-CCP antibody werepositive in 73% and 65% respectively. 35% (n = 9) of patients werebiologically naïve, in whom baricitinib was chosen due to needlephobia (n = 7), or where anti-TNF drugs were considered inappropriate(bronchiectasis, ANA positivity). Mean DAS28 (SD) scores at baseline, 6 and 12 months were 5.9(0.8), 2.8(0.9) and 2.7(1.3) respectively, withsignificant reduction from baseline to both 6 and 12 months(P < 0.001). A drop of 1.2 in DAS28 was recorded in 94% of patientswith complete data at 6 months (n = 18, 4 missing, 4 discontinued). At6 and 12 months, 85% and 81% of patients remained on Baricitinib. Intotal five patients discontinued Baricitinib due to side effects ortolerability issues. Reasons for discontinuation did not includethromboembolic events, zoster or serious infections. When comparingnaïve and non-naïve groups, there was no significant difference in age, sex or disease duration. The number of previous biologics used bypatients were 1(n = 6), 2(n = 3), 3(n = 8). Biologically naive comparedto non-naïve patients had a higher DAS28 at baseline, (Mean [SD])(6.2[0.9] versus 5.7[0.8] NS) but lower at 6 months (2.1[1.6] versus3.1[1.1] P = 0.023) and greater DAS improvement at 6months (-4.4[1.2]versus -2.5[0.9] P < 0.002).ConclusionWe observed that up to 94% of patients responded to baricitinib with amean DAS improvement at 6 months of -3.1, biologic naïve patientsdoing best. Drug survival at 12 months was 81%. These trends arecomparable to findings in clinical trials. However, due to our smallsample size, the findings are vulnerable to type 1 and 2 errors andshould be interpreted with caution.