Continuation vs withdrawal of golimumab treatment among patients with nonradiographic axial spondyloarthritis (nr-axSpA) is significantly more effective in reducing the number of disease flare-ups, according to study results published in Rheumatology.
GO-BACK was a phase 4, randomized, double-blind, parallel-group withdrawal study (ClinicalTrials.gov Identifier: NCT03253796). Participants were enrolled across 62 study locations in 9 European countries from November 2017 to March 2021. Eligible patients were aged between 18 and 45 years, had active nr-axSpA with objective signs of inflammation, a history of inadequate response or intolerance to 2 or more nonsteroidal anti-inflammatory drugs (NSAIDs), had an active diagnosis of nr-axSpa for 5 or fewer years from the onset of symptoms, had chronic back pain for 3 or more months, and wereNaive to tumor necrosis factor inhibitors (TNFis) and other biologic agents.
The study was divided into 2 study periods. In period 1, all participants received open-label golimumab 50mg subcutaneously every month for 10 months. Clinical response was assessed twice per month using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questionnaire.
Clinical response was defined as an improvement in the BASDAI score of at least 2 (≥50%) relative to month 0. Participants who met the criteria for clinical response by month 4 continued to receive monthly open-label golimumab. Of these participants, those who achieved inactive disease status by months 7 or 10 were eligible to enter period 2 of the study.
In period 2 of the study, patients were randomly assigned to receive monthly placebo (considered the treatment withdrawal arm), monthly golimumab treatment, or golimumab treatment once in 2 months. A total of 323 participants were initially enrolled in the study, with 116 (35.9%) discontinuing their participation during period 1; 175 (93.1%) participants eligible for period 2 completed the study.
The percentage of participants without a disease flare was significantly higher in both the golimumab groups vs the placebo group (84.1% and 68.3%, vs 33.9%, respectively; P <.001). In addition, the time-to-first flare was significantly longer for patients in both the golimumab groups compared with the placebo group (P <.0001). Of patients with a disease flare, 96.2% had a clinical response within 3 months after retreatment with golimumab,
Adverse events were consistent with the known safety profile of golimumab.
Overall, the study authors noted, “The current study reinforces the safety and tolerability of the use of GLM in patients with nr-axSpA.”
They concluded that the study results support the longer-term use of golimumab in patients with nr-axSpA even after an inactive disease state is achieved, as it may lessen the number of flare-ups, and thus, improve quality of life for patients.
Disclosure: This research was supported by Merck Sharp & Dohme, LLC. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Weinstein CLJ, Sliwinska-Stanczyk P, Hála T, et al. Efficacy and safety of golimumab in patients with non-radiographic axial spondyloarthritis: a withdrawal and retreatment study (GO-BACK). Rheumatology (Oxford). Published online March 15, 2023. doi:10.1093/rheumatology/kead112