Real-world evidence on baricitinib safety and efficacy in rheumatoid arthritis

Real-world data was the topic of a recent webinar on the use of baricitinib in the treatment of rheumatoid arthritis (RA). Presenter Professor Rieke Alten (University Medicine Berlin) took the virtual audience through key research findings as well as insights from her own clinical practice.

Real-world evidence for baricitinib maintenance after 4 years on the market 

An observational, prospective, cohort study analysed drug maintenance data from patients in the Swiss RA register between September 2017 and June 2020 initiating treatment with baricitinib (n=273) or alternative biologic disease-modifying antirheumatic drugs (bDMARDs; n=755) after failure of traditional synthetic (ts) DMARDs (n=1,028).1

Baricitinib was prescribed to significantly older patients, with longer disease duration and higher treatment failures. Despite this, drug maintenance was significantly shorter for tumour necrosis factor inhibitors (TNFi’s) compared to baricitinib (hazard ratio [HR] for drug discontinuation 1.85; 95% CI, 1.40–2.43; p<0.001). There was no significant difference between baricitinib and other bDMARDs.

“Baricitinib demonstrated a higher overall drug maintenance than the TNFi’s and a similar drug maintenance for other mechanisms of action, both in the biologic DMARD naïve population and in the overall population,” said Professor Alten

Baricitinib shows good effectiveness and tolerability in patients with severe long-standing RA disease2

An observational, prospective, cohort study of data from the British Society for Rheumatology Biologics Register (Rheumatoid Arthritis) examined drug maintenance and disease activity (DAS28-ESR score) at six-months post-commencement of baricitinib for the first 3 years and annually thereafter.2 Patients with RA initiated on therapy (n=409) were assessed as an overall population as well as within subgroups:

  • Patients with prior b/tsDMARD experience
  • Patients without prior b/tsDMARD experience
  • Patients receiving baricitinib monotherapy

Of note was a predominantly female study population (76.3%) with a median disease duration of 13 years (range=5.0–19.0) and a median DAS28-ESR score of 5.7 (IQR, 5.1 – 6.4). Among patients completing six-month follow-up, 74.9% remained on baricitinib. While sample sizes were small, analysis suggested good effectiveness for baricitinib (DAS28-ESR score) in all subgroups:

  • No prior b/tsDMARD (3.3; IQR, 2.0–4.4; n=45)
  • Prior b/tsDMARD (3.5; IQR, 2.6–5.1; n=86)
  • Baricitinib monotherapy (3.3; IQR, 2.5–4.5; n=50)

“In this study with patients with severe long-standing disease, in which almost two-thirds had received prior biologic or traditional synthetic DMARDs, baricitinib showed good effectiveness and tolerability,” said Professor Alten.

Promising data on drug maintenance and remission in patients receiving baricitinib3

A multinational, prospective, observational cohort study involving participants from France, Germany, Spain, Italy, and the UK analysed the real-world effectiveness (% of patients achieving remission or low Clinical Disease Activity Index [CDAI] score) of baricitinib versus b/tsDMARDs.

Treatment adherence, changes from baseline CDAI score, and patient reported outcomes (PRO: quality of life, pain, physical functioning) were also assessed. 3,4 Participants were separated into two cohorts:

  • Cohort A – 2mg or 4mg baricitinib (n=509); 50.9% monotherapy
  • Cohort B – tsDMARDs or bDMARDs (n=565); 31.2% monotherapy.4

While discontinuation rates were similar at three-months for both cohorts (A=52/392; 13.3%; B=59/425; 13.9%), patients in cohort A (63/336; 18.8%) were less likely to have discontinued treatment at six-months (cohort B: 93/370; 25.1%). Participants in cohort A were also more likely to have achieved remission at six-months (A=25.6%; B=18.5%) and reported lower CDAI scores. PROs were similar for both cohorts in relation to pain (HAQ-DI score) and quality of life (EQ-5D-5L score).

Interim results from Japanese baricitinib surveillance study ‘reassuring’

The All-Case Post-Marketing surveillance study has been operational in Japan since September 2017 following the approval of baricitinib in July 2017.5 Initial safety data for 24-week therapy of baricitinib in Japanese patients with RA is now available.  Three-year safety data are currently being investigated.

The study demographics (n=3,445) highlight a predominantly female population (80.2%), with a mean age of 63.5 years (SD=13.1) and a mean RA duration of 11.59 years (SD=10.47): “Typical of a patient population with rheumatoid arthritis,” said Professor Alten.

No new safety concerns were identified. Commonly reported adverse effects included hepatic disfunction disorder (2.9%) and herpes zoster (2.9%). Frequency of adverse events remained stable across participant age groups (up to 85 years) and did not increase between 75 and 85 years of age. “For me, the data up to age 85 years is reassuring,” Professor Alten remarked.

This article was commissioned by Eli Lilly Australia Pty Ltd. Any views expressed in the article are those of the expert alone and do not necessarily reflect the views of the sponsor. Before prescribing please review the Olumiant® (link) full product information via the TGA website. Treatment decisions based on these data are the responsibility of the prescribing physician.

PP-BA-AU-0873; Date of preparation: March 2021

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