Baseline characteristics of patients from the PREVENT cohorta. Values are mean ± SD or % unless otherwise specified.
| Variable | Infection Group, n = 61 | Noninfection group, n = 702 | p | Adjusted HR (95% CI) |
|---|---|---|---|---|
| Age, yrs | 65.8 ± 13.1 | 52.1 ± 18.1 | 0.03 | 1.05 (1.03–1.07) |
| Age ≥ 65 yrs old | 63.9 | 29.2 | < 0.01 | 4.01 (2.37–6.80) |
| Female sex | 62.3 | 75.1 | 0.03 | 0.69 (0.41–1.16) |
| Body weight, kg | 52.6 ± 9.8 | 54.0 ±10.9 | 0.63 | 0.99 (0.96–1.02) |
| Disease duration, mos | 42.2 ± 75.8 | 57.8 ± 90.1, n = 701 | 0.09 | 0.98 (0.99–1.01) |
| Incident use of immunosuppressive therapy | 65.6 | 50.3 | 0.02 | 1.83 (1.08–3.10) |
| Ever smoker | 45.9 | 33.5, n = 701 | 0.06 | 1.59 (0.85–2.97) |
| ≥ 20 pack-yrs of smokingb | 41.0 | 17.5, n = 695 | < 0.01 | 2.42 (1.28–4.56) |
| Concurrent nonserious infection | 4.9 | 3.1 | 0.45 | 1.14 (0.36–3.68) |
| Resolved serious infection within 6 mos | 4.9 | 1.3 | 0.03 | 2.76 (0.86–8.86) |
| Performance status ≥ 3c | 24.6 | 11.8 | < 0.01 | 1.83 (1.01–3.32) |
| Dysphagia | 4.9 | 2.3 | 0.24 | 2.56 (0.80–8.20) |
| Heart failure | 6.6 | 3.3 | 0.18 | 2.04 (0.74–5.66) |
| Diabetes mellitus | 26.2 | 14.4 | 0.01 | 1.19 (0.66–2.14) |
| Previous pulmonary tuberculosisd | 14.8 | 5.3 | < 0.01 | 1.72 (0.83–3.56) |
| Any pulmonary comorbidity | 59.0 | 36.0 | < 0.01 | 1.49 (0.87–2.53) |
| Interstitial pneumonia | 42.6 | 25.7 | < 0.01 | 1.34 (0.80–2.25) |
| COPD | 8.2 | 2.1 | < 0.01 | 2.25 (0.85–5.93) |
| Serum creatinine, mg/dl | 1.08 ± 1.35 | 0.74 ± 0.67, n = 701 | 0.01 | 1.24 (1.07–1.44) |
| Serum albumin, mg/dl | 3.15 ± 0.65, n = 60 | 3.33 ± 0.68, n = 694 | 0.03 | 0.83 (0.56–1.24) |
| Pneumococcal vaccinee | 6.6 | 7.5 | 0.77 | 0.14 (0.17–0.29) |
| Influenza vaccinef | 26.2 | 22.9 | 0.56 | 1.09 (0.62–1.93) |
| Medication during the first 14 days of immunosuppressive treatment | ||||
| Maximum PSL doseg, mg/kg/day | 0.83 ± 0.34 | 0.68 ± 0.41 | 0.02 | 4.06 (2.03–8.14) |
| Use of ≥ 0.5 mg/kg/day of PSL, yesh | 85.2 | 65.3 | < 0.01 | 3.69 (1.82–7.50) |
| Use of mPSL pulse therapy, yesh | 26.2 | 17.1 | 0.07 | 2.00 (1.13–3.55) |
| Use of conventional immunosuppressantsi, yesh | 29.5 | 43.7 | 0.03 | 0.60 (0.34–1.04) |
| Use of biologicsi, yesh | 11.5 | 18.7 | 0.16 | 0.48 (0.22–1.06) |
| Diagnosis | ||||
| SLE | 18.0 | 28.9 | 0.07 | 1.71 (1.03–2.85)j |
| RA | 18.0 | 27.1 | ||
| Vasculitis | 31.1 | 14.7 | ||
| PM/DM | 19.7 | 14.7 | ||
| AOSD | 4.9 | 5.7 | ||
| MCTD | 3.3 | 2.8 | ||
| SSc | 3.3 | 2.1 | ||
| Behçet’s disease | 0.0 | 1.6 | ||
| SS | 1.6 | 1.1 | ||
↵a Patients who developed (infection group) and did not develop PI (noninfection group) were compared. The Mann-Whitney U test was used for continuous measures, and the chi-square test for categorical measures to calculate p values between the infection group and the noninfection group. Corrections for multiple comparisons were not applied and p values were provided to show magnitude of difference between the 2 groups. The age- and sex-adjusted HR for development of PI was calculated for each variable using Cox proportional hazard regression analysis.
↵b Pack-years of smoking: packs smoked per day × yrs as a smoker.
↵c Performance status was evaluated using the Eastern Cooperative Oncology Group performance status.
↵d Previous pulmonary tuberculosis includes suspected case.
↵e Patients who were given pneumococcal vaccine before enrollment and during the observation period were included in calculation of percentages. Patients who were given pneumococcal vaccine after development of PI were excluded from the calculation.
↵f Patients who were given influenza vaccine within 6 months before enrollment and during the observation period were included in calculation of percentages. Patients who were given influenza vaccine after development of PI were excluded.
↵g Maximum PSL dose during the first 14 days of immunosuppressive therapy. The dose of corticosteroids other than PSL was substituted for the equivalent dose of PSL for analysis23.
↵h Use of > 0.5 mg/kg/day of PSL, mPSL pulse therapy, conventional immunosuppressants, and biologics during the first 14 days of immunosuppressive therapy were included.
↵i Included immunosuppressants and biologics are shown in Supplementary Table 1 (available online at jrheum.org).
↵j HR of vasculitis and PM/DM versus other CTD was calculated. PREVENT: Pulmonary infections in patients REceiving immunosuppressiVE treatmeNT for CTD; COPD: chronic obstructive pulmonary disease; PSL: prednisolone; mPSL: methylprednisolone; Ig: immunoglobulin; SLE: systemic lupus erythematosus; RA: rheumatoid arthritis; PM: polymyositis; DM: dermatomyositis; AOSD: adult-onset Still’s disease; MCTD: mixed connective tissue diseases; SSc: systemic sclerosis; SS: Sjögren syndrome; PI: pulmonary infections; CTD: connective tissue diseases.