Long-Term Durability of Certolizumab Pegol in Patients with Rheumatoid Arthritis Over 5 Years: An Analysis of Pooled Clinical Trial Data

Vivian P Bykerk; Peter Nash; David Nicholls; Yoshiya Tanaka; Kevin Winthrop; Christina Popova; Nicola Tilt; Derek Haaland

doi:10.1007/s40744-023-00541-5

Long-Term Durability of Certolizumab Pegol in Patients with Rheumatoid Arthritis Over 5 Years: An Analysis of Pooled Clinical Trial Data

Rheumatol Ther. 2023 Jun;10(3):693-706. doi: 10.1007/s40744-023-00541-5. Epub 2023 Feb 27.

Authors

Vivian P Bykerk¹, Peter Nash², David Nicholls³, Yoshiya Tanaka⁴, Kevin Winthrop⁵, Christina Popova⁶, Nicola Tilt⁷, Derek Haaland^{8

9}

Affiliations

¹ Hospital for Special Surgery, New York, NY, USA.
² Griffith University, Queensland, Australia. drpnash@tpg.com.au.
³ University of the Sunshine Coast, Queensland, Australia.
⁴ University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
⁵ Oregon Health and Science University, Portland, OR, USA.
⁶ UCB Pharma, Brussels, Belgium.
⁷ UCB Pharma, Slough, UK.
⁸ McMaster University, Hamilton, ON, Canada.
⁹ The Waterside Clinic, Barrie, ON, Canada.

Abstract

Introduction: There is a paucity of data on how patient characteristics may affect the long-term durability of certolizumab pegol (CZP) in patients with rheumatoid arthritis (RA). This study therefore aimed to investigate CZP durability and reasons for discontinuation over 5 years between different subgroups of patients with RA.

Methods: Data were pooled from 27 clinical trials in RA patients. Durability was defined as the percentage of patients randomized to CZP at baseline who were still on CZP treatment at a given timepoint. Post hoc analyses of clinical trial data on CZP durability and reasons for discontinuation among different patient subgroups were conducted using Kaplan-Meier curves and Cox proportional hazards modeling. Patient subgroups included: age (18- < 45/45- < 65/ ≥ 65 years), gender (male/female), prior tumor necrosis factor inhibitor (TNFi) use (yes/no), and disease duration (< 1/1- < 5/5- < 10/ ≥ 10 years).

Results: Among 6927 patients, the durability of CZP was 39.7% at 5 years. Patients aged ≥ 65 years had a 33% greater risk of CZP discontinuation than patients 18- < 45 years (hazard ratio [95% confidence interval]: 1.33 [1.19-1.49]) and patients with prior TNFi use had a 24% greater risk of discontinuing CZP than patients without (1.24 [1.12-1.37]). Conversely, greater durability was observed among patients who had a baseline disease duration of ≥ 1 year. Durability did not differ in the gender subgroup. Of the 6927 patients, the most common reason for discontinuation was inadequate levels of efficacy (13.5%); followed by adverse events (11.9%); consent withdrawn (6.7%); lost to follow-up (1.8%); protocol violation (1.7%); other reasons (9.3%).

Conclusions: CZP durability was comparable with durability data on other bDMARDs in RA patients. Patient characteristics that were associated with greater durability included younger age, TNFi-naïvety, and disease duration ≥ 1 year. Findings may be helpful in informing clinicians on a patient's likelihood of discontinuing CZP, based on their baseline characteristics.

Keywords: Certolizumab pegol; Durability; Rheumatoid arthritis; Tumor necrosis factor inhibitors.