A total of 1231 patients treated with SC golimumab were included in the analysis, of whom 529 had RA, 281 had PsA, and 421 had axSpA. At baseline, mean (SD) patient age was 57.7 (13.0), 52.8 (13.2) and 45.7 (13.3) years in the RA, PsA, and axSpA groups, respectively; analogously 31.6%, 18.1%, and 8.6% of patients were ≥ 65 years (Table 1). Most patients were female in the RA (76.2%) and PsA (53.7%) groups, as were just under half in the axSpA group (40.9%). Mean (SD) disease duration ranged from 6.0 years in the axSpA and PsA groups to 8.0 (8.3) years in the RA group. In all groups, disease activity scores were indicative of highly active disease, with mean (SD) CDAI of 26.1 (13.9) in the RA group, cDAPSA of 31.1 (18.7) in the PsA group, and BASDAI of 6.1 (2.1) in the axSpA group. A moderate impairment in physical function was noted across the respective groups, with mean (SD) HAQ-DI scores of 1.3 (0.7), 1.1 (0.7) and 1.0 (0.6). A small proportion of patients reported prior TNFi use in the RA (13.6%), PsA (22.1%), and axSpA (17.3%) groups. Proportions of patients who were current smokers were 20.0%, 18.9%, and 25.5%, in the respective disease groups. Baseline steroid use was reported by most patients in the RA (32.9%) and PsA (21.0%) groups, versus only a minority of patients in the axSpA group (12.1%). MTX use at baseline was reported by 67.3%, 61.2%, and 9.7% of patients in the RA, PsA, and axSpA groups, respectively.

IRs of AEoSI were evaluated over 1064, 539, and 675 PYs in the RA, PsA, and axSpA groups, respectively (Table 2). The IR (95% confidence interval, CI) of MACE was 1.1 (0.6, 2.0) events/100 PYs in the RA group with no events in the PsA and axSpA groups. The incidence of malignancy in the respective groups was 1.4 (0.8, 2.3), 0.4 (0.0, 1.3), and 1.0 (0.4, 2.1) events/100 PYs. All-cause mortality IRs (95% CI) were 0.7 (0.3, 1.4), 0.2 (0.0, 1.0), and 0.3 (0.0, 1.1) events/100 PYs among patients with RA, PsA, and axSpA, respectively. IRs (95% CI) of SAEs were 11.4 (9.4, 13.6) events/100 PYs for RA, 7.6 (5.5, 10.3) events/100 PYs for PsA, and 8.4 (6.4, 10.9) events/100 PYs for axSpA. SI events occurred at IRs (95% CI) of 2.3 (1.4, 3.4), 1.3 (0.5, 2.7), and 2.2 (1.2, 3.7) events/100 PYs in the respective groups.

Overall, across all AEoSI, no new safety signals emerged. Unadjusted analyses demonstrated numerical differences in crude IRs of AEoSI for certain risk factors across the RA, PsA and axSpA groups (Table 3). Specifically, older patients (≥ 65 years) across all disease groups had higher IR/100 PYs of malignancy (range 1.2–5.7 versus 0.1–0.5), mortality (1.2–2.9 versus 0.0), SAE (19.2–27.2 versus 4.8–7.8), and SI (3.0–8.4 versus 0.0–1.9) compared with younger patients (< 65 years). Additionally, patients with RA aged ≥ 65 years also had a higher IR (95% CI) of MACE than those < 65 years (2.4 [1.0, 4.7] versus 0.5 [0.1, 1.4]).

Males in the RA group had higher IRs (95% CI) of MACE (1.8 [0.6, 4.1] versus 0.9 [0.4, 1.9]), SAE (14.7 [10.6, 19.9] versus 10.1 [8.0, 12.6]), and SI (3.2 [1.4, 6.0] versus 1.9 [1.1, 3.2]) than females. In the PsA group, the incidence (95% CI) of malignancy was higher among males than females (0.7 [0.1, 2.5] versus 0.0 [not calculable, NC]), whereas IRs of SAE (9.3 [5.9, 13.9] versus 6.2 [3.7, 9.8]) and SI (2.4 [0.9, 5.3] versus 0.3 [0.0, 1.9]) were higher among females. IRs (95% CI) of malignancy (1.4 [0.5, 3.0] versus 0.4 [0.0, 2.3]) were higher among males than females with axSpA, while the incidence of SI was higher for females (3.8 [1.7, 7.2] versus 1.4 [0.5, 3.0]). Across disease groups, mortality rates for females ranged between 0.4 and 0.9 and 0.0 to 0.2 for males.

Current smokers versus non-smokers in the RA group had higher incidence (95% CI) of SAE (14.3 [9.6, 20.5] versus 10.6 [8.6, 13.1]) and SI (4.4 [2.0, 8.4] versus 1.8 [1.0, 2.9]). In the PsA group, current smokers compared with non-smokers had higher IRs (95% CI) of malignancy (1.1 [0.0, 6.2] versus 0.2 [0.0, 1.3]), mortality (1.1 [0.0, 6.2] versus 0.2 [0.0, 1.3]), and SAE (13.4 [6.9, 23.4] versus 6.5 [4.4, 9.4]). Higher IRs (95% CI) of SAE (12.6 [7.9, 19.1] versus 7.0 [4.9, 9.8]), and SI (3.4 [1.3, 7.5] versus 1.8 [0.8, 3.4]) were found among current smokers than non-smokers in the axSpA group.

The crude IR (95% CI) of malignancy was higher for TNFi-experienced patients with RA compared with those who were TNFi-naïve (3.2 [0.9, 8.1] versus 1.2 [0.6, 2.1]). Among patients with PsA and prior TNFi experience, the incidence (95% CI) of malignancy (1.9 [0.2, 6.8] versus 0.0 [NC]), SAE (15.1 [8.6, 24.5] versus 5.8 [3.7, 8.5]) and SI (4.7 [1.5, 11.0] versus 0.5 [0.1, 1.7]) was higher than for those who were TNFi-naïve. Similar trends were observed among patients with axSpA defined by TNFi treatment history. IRs of mortality (0.3 [0.0, 1.7] versus 0.0, [NC]), SAE (9.7 [6.6, 13.6] versus 4.3 [2.0, 8.2) and SI (2.1 [0.8, 4.4] versus 0.0 [NC]) in the PsA group were higher among patients with than without baseline MTX use, with similar trends found among patients with axSpA. Patients with PsA receiving steroids at baseline had a higher IR (95% CI) of SAE (11.5 [6.0, 20.1]) than those without baseline steroids (6.7 [4.5, 9.6]), and higher IRs of malignancy (6.6 [1.4, 19.2] versus 0.6 [0.2, 1.6)], mortality (2.2 [0.1, 12.2] versus 0.2 [0.0, 0.9]), and SAE (17.5 [7.6, 34.5] versus 7.8 [5.8, 10.3]) were found with than without baseline steroid use in the axSpA group.

Among patients with RA, the mean (95% CI) time to MACE was significantly shorter among older patients (< 65 versus ≥ 65 years: 88.8 [87.6–90.1] versus 82.0 [77.7–86.2] months, p = 0.007, Fig. 1A), with no impact of sex, prior TNFi experience, smoking status, or baseline use of steroids or MTX (Fig. 1B–F). Across all disease groups, no significant differences were observed in the time to malignancy, death, SAE, and SI for any of the risk factors of interest (data not shown).

Time to MACE by age (A), sex (B), prior TNFi experience (C), smoking status (D), baseline use of oral steroid (E), and baseline use of MTX (F) among patients with RA. Exp experienced, MACE major adverse cardiovascular events, MTX methotrexate, RA rheumatoid arthritis, TNFi tumor necrosis factor inhibitor