Background:Golimumab (GLM) was the latest anti-TNFα therapy to be indicated in the treatment of chronic inflammatory rheumatic diseases. The pivotal GO-AFTER study [1] and the ongoing observational GO-BEYOND study investigate GLM efficacy in rheumatoid arthritis (RA) patients who previously received biologics. However, clinical studies of GLM in axial spondyloarthritis (AS) are lacking. Using data from the GO-PRACTICE study, we examined GLM persistence in patients with aS.Objectives:Primary objective was to estimate GLM persistence at 2 years from initial prescription, as a first line of treatment (in biologic naïve patients:BN) and as a second or further line of treatment (in biologic pretreated patients:BP). Persistence was estimated with the Kaplan-Meier method. Secondary outcomes included assessing disease activity (ASDAS) evolution and patient-reported evaluations of disease activity (BASDAI), pain (VAS), functional ability (HAQ) and quality of life (EQ-5D and SF-12).Methods:Observational, prospective, multicenter French study, that recruited adult patients with RA, psoriatic arthritis or aS, who were newly prescribed GLM. Patients were followed-up over 2 years; data were collected at baseline (BL), 1 year and 2 years. This abstract presents results from the aS cohort of GO-PRACTICE.Results:478 patients with aS (constituting 63% of the total cohort) from 134 sites were included from January 2015 to March 2016. Mean age was 43 years, 55% were female; 61% were BN (n=291) and 39% (n=187) were BP. Mean duration of aS was 5.5 and 10.7 years in BN and BP patients, respectively (P<.001). At BL most were prescribed 50 mg GLM monthly (97%). Co-treatments were disease-modifying anti-rheumatic drugs (34%), corticosteroids (17%) and NSAIDs/analgesics (90%). GLM persistence over 2 years was significantly higher in BN than BP patients (59.2% vs 45.1%, p<.01). For those still on GLM at 2 years, disease activity (Table1) and patient assessments showed significant improvements for both, BN and BP patients, with improvements being greater in BN patients. GLM was well tolerated in aS patients (n=478), with 46 (9.6%) discontinuing due to intolerance. Among BN patients, 18 (6.2%) discontinued GLM due to primary treatment failure, compared to 28 BP patients (15%). GLM was re-prescribed for 213 (88%) of the 241 patients persisting on GLM at 2-years. Post-hoc multivariate analysis showed that being female was a risk factor for GLM discontinuation in aS patients (HR1.9, IC95% 1.4-2.6).Table 1Disease activity at BL and 2 years for BN and BP patients with aS persisting on GLM
BN patients
BP patients
BL
2
years
BL
2
years
P*
ASDAS-CRP, Mean (SD)
3.2(0.8)1.5(0.9)3.1(0.8)2.0(1.0)
P
=.0051
BASDAI, Mean (SD)
5.3(1.7)2.6(1.9)5.7(1.6)3.1(2.0)
P <.0001*P is from a 2-factor repeated-measures model testing the significance of the effect of prior biologic treatment on score evolution, adjusted to timeConclusion:GLM is associated with clinical improvements and good persistence in aS patients, especially those who are biologic naïve.Refe...