Crude incidence rates and HRs for lupus/vasculitis type events in nbDMARD and TNFi-treated patients (on drug+90 days analysis)
| nbDMARD (n=3673) | All TNFi (n=12 937) | Etanercept (n=4516) | Adalimumab (n=4362) | Infliximab (n=3363) | Certolizumab (n=696) | |
|---|---|---|---|---|---|---|
| Lupus-like events | ||||||
| Total follow-up time (patient-years) | 20 815 | 53 159 | 21 595 | 17 343 | 13 181 | 1040 |
| Follow-up per subject, median (IQR) | 6.5 (3.4–9.0) | 5.1 (2.0–8.9) | 6.3 (2.5–10.0) | 5.3 (2.2–8.0) | 4.2 (1.6–8.4) | 1.5 (0.8–2.6) |
| Number | 5 | 54 | 20 | 11 | 23 | 0 |
| Crude incidence rate of lupus-like event per 10 000 person-years (95% CI) | 2.4 (1.0 to 5.7) | 10.2 (7.8 to 13.2) | 9.3 (6.0 to 14.3) | 6.3 (3.5 to 11.5) | 17.5 (11.6 to 26.3) | – |
| Unadjusted HR (95% CI) | Referent | 3.93 (1.57 to 9.83)* | 3.83 (1.44 to 10.21)* | 2.40 (0.83 to 6.92) | 6.59 (2.50 to 17.36)* | – |
| Age and gender adjusted (95% CI) | Referent | 3.72 (1.47 to 9.35)* | 3.60 (1.34 to 9.64)* | 2.26 (0.78 to 6.53) | 6.28 (2.38 to 16.61)* | – |
| Propensity score adjusted HR (95% CI)† | Referent | 1.86 (0.52 to 6.58) | 1.41 (0.41 to 4.90) | 1.77 (0.33 to 9.36) | 2.65 (0.75 to 9.35) | – |
| n=3640 | n=12 745 | n=4450 | n=4312 | n=3292 | n=691 | |
| Vasculitis-like events | ||||||
| Total follow-up time (patient-years) | 20 635 | 52 428 | 21 320 | 17 172 | 12 903 | 1033 |
| Follow-up per subject; median (IQR) | 6.5 (3.4–9.0) | 5.1 (2.0–8.9) | 6.3 (2.5–10.0) | 5.3 (2.2–8.0) | 4.2 (1.6–8.5) | 1.5 (0.8–2.6) |
| Number of vasculitis-like events, n | 14 | 81 | 37 | 18 | 26 | 0 |
| Crude incidence rate of vasculitis-like events per 10 000 person-years (95% CI) | 6.8 (4.0 to 12.4) | 15.5 (12.4 to 19.2) | 17.4 (12.6 to 24.0) | 10.5 (6.6 to 16.6) | 20.2 (13.7 to 29.6) | – |
| Unadjusted HR (95% CI) | Referent | 2.12 (1.20 to 3.74)* | 2.58 (1.39 to 4.77)* | 1.38 (0.69 to 2.78) | 2.70 (1.41 to 5.18)* | – |
| Age- and gender-adjusted HR (95% CI) | Referent | 2.31 (1.30 to 4.09)* | 2.84 (1.52 to 5.28)* | 1.50 (0.74 to 3.03) | 2.93 (1.52 to 5.64)* | – |
| Propensity score-adjusted HR (95% CI)‡ | Referent | 1.27 (0.40 to 4.04) | 1.72 (0.53 to 5.57) | 0.71 (0.21 to 2.47) | 1.55 (0.46 to 5.20) | – |
*p<0.05.
†Adjusted for age, gender, disease duration, baseline DAS28 score, baseline HAQ score, comorbidities, rheumatoid factor-positive status, year of recruitment, baseline steroid use, baseline nbDMARD use and ethnicity.
‡Adjusted for age, gender, disease duration, baseline DAS28 score, baseline HAQ score, comorbidities, rheumatoid factor-positive status, year of recruitment, baseline steroid and nbDMARD use.
DAS28, 28 joint count Disease Activity Score; HAQ, Health Assessment Questionnaire; nbDMARDs, non-biological disease-modifying antirheumatic drugs; TNFi, tumour necrosis factor-α inhibitor.