Spondyloarthritis & psoriatic arthritis
Efficacy and safety of golimumab in patients with non-radiographic axial spondyloarthritis: a withdrawal and retreatment study (GO-BACK)
Authors' conclusion
Among participants with active nr-axSpA who attained inactive disease after 10 months of GLM treatment, continued GLM treatment is well tolerated and provides superior protection against disease flares compared with GLM withdrawal.
Study context
- Population
- Adults with non-radiographic axial spondyloarthritis (nr-axSpA) who achieved inactive disease during a 10-month open-label golimumab (GLM) run-in323 enrolled
- Participants
- 188 adults
- Comparison
- Continued golimumab monthly or every 2 months vs placebo (treatment withdrawal) in nr-axSpA with inactive disease
- Primary endpoint
- Proportion of participants without a disease flare, continued GLM (QMT or Q2MT) vs PBO
- Follow-up
- ∼12 months
Methodological detailsrandomised withdrawal and retreatment, double-blind, placebo-controlled, 10-month open-label GLM run-in, 1:1:1 randomisation, multiplicity-controlled, step-down testing
- Randomised withdrawal and retreatment
- Double-blind
- Placebo-controlled
- 10-month open-label GLM run-in
- 1:1:1 randomisation
- Multiplicity-controlled, step-down testing
Primary result
As reported in the abstract
Participants without disease flare
Treatment-difference
50.4%
P < 0.001
GLM QMT
Treatment-difference
34.4%
P < 0.001
GLM Q2MT
Further findings
| Outcome | P value |
|---|---|
| Time to first flareGLM QMT vs PBO · GLM treatment vs PBO; significantly longer with GLM | log-rank P < 0.0001 |
Clinical response within 3 months of restarting open-label (OL) GLM after confirmed flare (Q2MT or placebo (PBO))
- 51 of 53 participants with confirmed flare attained clinical response
- 96.2%
Safety
Adverse events
- Consistent with the known GLM safety profile
Original publication
Efficacy and safety of golimumab in patients with non-radiographic axial spondyloarthritis: a withdrawal and retreatment study (GO-BACK). Rheumatology (Oxford). Published 15 March 2023. doi:10.
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