TABLE 1.
Study outcomes assessed at 6 weeks
| High-dose prednisolone | Low-dose prednisolone | Mean difference (95% CI) | p-value | |
| Patients, n | 65 | 65 | ||
| Primary outcome | ||||
| Complete radiological response# | 16 (24.6) | 12 (18.5) | −0.06 (−0.20–0.08) | 0.39 |
| Key secondary outcomes | ||||
| Complete/good radiological response# | 55 (84.6) | 52 (80.0) | −0.05 (−0.18–0.09) | 0.49 |
| FVC, % predicted¶ | 71.1±16.3 | 67.4±14.8 | −3.7 (−9.4–2.0) | 0.21 |
| Improvement in resting SpO2,+ % | 2 (0–6) | 2 (1–6) | 0.91 | |
| Improvement in dyspnoea, mMRC score+ | 1 (1–2) | 2 (1–2) | 0.52 | |
| ≥1 point improvement+ | 56 (91.8) | 56 (93.3) | 0.02 (−0.09–0.12) | 1.00 |
| Other secondary outcomes | ||||
| Good composite response# | 10 (15.4) | 10 (15.4) | 0 (−0.13–0.13) | 1.00 |
| Oxygen desaturation on exercise+ | 30 (52.6) | 30 (50.8) | −0.02 (−0.19–0.16) | 0.85 |
| Score on the FACIT-Dyspnea scale+ | 45.5±11.4 | 43.3±9.8 | −2.2 (−6.0–1.6) | 0.25 |
| K-BILD total score+ | 65.6±13.7 | 64.9±15.6 | −0.7 (−5.9–4.6) | 0.79 |
| Short form-36 component scores + | ||||
| Physical functioning | 59.4±26.3 | 62.9±28.5 | 3.5 (−6.4–13.4) | 0.49 |
| Role limitation – physical | 61.5±23.1 | 58.3±27.9 | −3.2 (−12.4–6.0) | 0.50 |
| Role limitation – emotional | 74.9±30.8 | 69.4±35.9 | −5.5 (−17.5–6.5) | 0.38 |
| Vitality | 59.7±18.1 | 59.6±20.9 | −0.1 (−7.1–6.9) | 0.98 |
| Mental health | 71.8±17.7 | 68.6±19.6 | −3.2 (−9.9–3.5) | 0.35 |
| Social functioning | 76.4±25.4 | 69.2±29.9 | −7.2 (−17.2–2.8) | 0.15 |
| Bodily pain | 75.9±22.0 | 72.5±25.8 | −3.4 (−12.0–5.2) | 0.43 |
| General health | 63.9±18.7 | 61.6±19.9 | −2.3 (−9.3–4.7) | 0.51 |
| Exploratory outcomes | ||||
| 6MWD,§ m | 349±93 | 318±129 | −31.0 (−71.4–9.4) | 0.15 |
| Improvement in 6MWD,ƒ m | 86 (33–128) | 70 (43–170) | 0.55 | |
| Change in chest CT scores + ,## | ||||
| Ground-glass opacities | −1.01±1.63 | −0.53±1.45 | 0.48 (−0.08–1.04) | 0.09 |
| Consolidation | −1.16±0.88 | −1.13±1.10 | 0.03 (−0.33–0.39) | 0.88 |
| Reticulation | −0.08±0.85 | −0.02±0.80 | 0.06 (−0.24–0.36) | 0.71 |
| Parenchymal bands | 0.14±0.77 | 0.28±0.87 | 0.14 (−0.16–0.44) | 0.35 |
| Traction bronchiectasis | 0.36±1.13 | 0.37±1.22 | 0.01 (−0.41–0.43) | 0.98 |
| Adverse effects# | ||||
| Any | 46 (70.8) | 50 (76.9) | 0.06 (−0.09–0.21) | 0.55 |
| Hyperglycaemia | 21 (32.3) | 19 (29.2) | −0.03 (−0.19–0.13) | 0.20 |
| Hypertension | 15 (23.1) | 14 (21.5) | −0.02 (−0.16–0.13) | 0.83 |
| Cushingoid habitus | 13 (20.0) | 13 (20.0) | 0 (−0.13–0.13) | 1.00 |
| Fatigue | 9 (13.8) | 13 (20.0) | 0.06 (−0.07–0.19) | 0.48 |
| Weight gain (>10% of baseline) | 4 (6.2) | 5 (7.7) | 0.02 (−0.08–0.11) | 1.00 |
| Dyspepsia | 3 (4.6) | 7 (10.8) | 0.06 (−0.04–0.16) | 0.19 |
| Others¶¶ | 19 (29.2) | 27 (41.5) | 0.12 (−0.04–0.28) | 0.20 |
Data are presented as n (%), mean±sd or median (interquartile range), unless otherwise stated. FVC: forced vital capacity; SpO2; peripheral oxygen saturation; mMRC: modified Medical Research Council; FACIT: Functional Assessment of Chronic Illness Therapy; K-BILD: King's Brief Interstitial Lung Disease; 6MWD: 6-min walk distance; CT: computed tomography. #: outcomes presented for all subjects (n=65 in each group) with the worse outcomes assumed for those who were lost to follow-up; ¶: 59 subjects in the high-dose group and 57 in the low-dose group were able to perform spirometry; +: outcomes reported for patients who completed follow-up (high-dose group n=61, low-dose group n=60); §: 57 and 59 subjects could perform the 6-min walk test (6MWT) at 6 weeks in the high-dose and low-dose groups, respectively; ƒ: paired data available for 6MWT for 44 (high-dose group) and 37 (low-dose group) subjects; ##: ground-glass opacities, consolidation, reticulation and parenchymal bands were scored semi-quantitatively in each lobe (right upper lobe, right middle lobe, right lower lobe, left upper lobe/lingula and left lower lobe) on chest CT. A score of 0 indicates no involvement, 1 represents <5% of lobe involved (present but minimal), 2 reflects 5–25%, 3 indicates 25–49%, 4 signifies 50–75% and 5 denotes >75% involvement. For each feature, the lobe scores were summed and divided by five to obtain an average (scale of 0–5), indicating the proportion of the total lung parenchyma showing the feature. Traction bronchiectasis was scored as absent (0) or present (1) for each lobe. The total score for traction bronchiectasis was calculated by summing up the respective scores for the five lobes; ¶¶: other adverse effects (rarer events with <10 events in the study population) included skin thinning and bruising, insomnia, muscular weakness, mood changes, abdominal pain, infection, headache, visual disturbance, dysgeusia, hypertrichosis and acne.