Mortality rates and cause of death in patients with ILD treated with first-line TNFi or RTX in an intention to treat analysis
| RTX n=42 | All TNFi n=309 | |||
| Total follow-up time (pyrs) | 256.0 | 2564.0 | ||
| Total follow-up time (pyrs) censored at 5-year follow-up | 150.7 | 801.3 | ||
| Median (IQR) follow-up per person (years) | 6.3 (5.3–7.3) | 9.1 (5.0–12.0) | ||
| Median (IQR) follow-up per person (years) censored at 5-year follow-up | 3.9 (2.6–4.4) | 2.7 (1.2–4.1) | ||
| Deaths within first 5 years following treatment start | ||||
| All-cause (n) | 8 | 76 | ||
| All-cause mortality/1000 pyrs (95% CI) | 53.0 (22.9 to 104.6) | 94.8 (74.7 to 118.7) | ||
| Cox regression models of relationship between treatment group and mortality* | ||||
| Unadjusted model | ||||
| HR | 95% CI | p Value | ||
| Treatment | TNFi | 1.0 | 0.09 | |
| RTX | 0.53 | 0.26–1.10 | ||
| Adjusted model† | ||||
| Treatment | TNFi | 1.0 | 0.07 | |
| RTX | 0.49 | 0.23–1.06 | ||
| Cause of death | ||||
| Deaths (n) | 8 | 76 | ||
| Death certificate information not yet reported to register (n) | 1‡ | 1‡ | ||
| ILD present on a death certificate (%)§ | 5 (71.4) | 27 (36.5) | ||
| ILD listed as the underlying cause of death (%)§ | 1 (14.3) | 12 (16.0) | ||
| ILD present in section I on death certificate, n(%)§ | 2 (40.0) | 20 (27.0) | ||
| ILD on a death certificate I(a) (%)§ | 1 (20.0) | 5 (6.8) | ||
| ILD on a death certificate I(b) (%)§ | 0 | 14 (18.9) | ||
| ILD on a death certificate I(c) (%)§ | 1 (20.0) | 1 (1.3) | ||
| ILD on a death certificate II (%)§ | 3 (42.8) | 7 (9.5) | ||
*Analysis conducted using multiple imputation for missing data.
†Age, disability (HAQ), disease activity (DAS28), disease duration and sex adjusted.
‡Death occurred outside of the UK and therefore no death certificate and the cause of death cannot be determined.
§Percentage of those with death certificate data available.
DAS28, disease activity score-28; ILD, interstitial lung disease; HAQ, Health Assessment Questionnaire; pyrs, person years; RTX, rituximab; TNFi, tumour necrosis factor inhibitors.