Improvement in Subjective Symptoms and Tolerability in Response to Nintedanib Treatment in Elderly Patients with Idiopathic Pulmonary Fibrosis
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patients
2.2. Subjective Assessments
2.3. Physiological Assessments
2.4. Gender, Age and 2 Lung Physiology Variables (GAP) Stage
2.5. Japanese Severity Stage
2.6. Adverse Events
2.7. Statistical Analysis
3. Results
3.1. Baseline Patient Characteristics
3.2. Therapeutic Effects of Nintedanib on Subjective Symptoms
3.3. Therapeutic Effects of Nintedanib on Forced Vital Capacity
3.4. Changes in Modified Medical Research Council (mMRC) Grades and Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores
3.5. Relationship between Subjective and Objective Improvement
3.6. Idiopathic Pulmonary Fibrosis with Acute Exacerbation (IPF-AE)
3.7. Adverse Events
3.8. Logistic Regression Analysis and Multiple Linear Regression Analysis
4. Discussion
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Total (n = 54) | ≥75 years (n = 32) | <75 years (n = 22) | p-value | |
---|---|---|---|---|
Mean age (years, SD) | 74.50 (4.90) | 77.75 (2.68) | 69.86 (3.43) | <0.001 |
Sex (women / men; n, %) | 7 (13.0%) / 47 (87.0%) | 5 (15.6%) / 27 (84.4%) | 2 (9.1%) / 20 (90.9%) | 0.687 |
Never smoker (n, %) | 20 (37.0%) | 12 (37.5%) | 8 (36.4%) | 1.000 |
mMRC grade 0 / 1 / 2 / 3 / 4 (n, %) | 3 (5.6%) / 12 (22.2%) / 31 (57.4%) / 6 (11.1%) / 2 (3.7%) | 2 (6.2%) / 7 (21.9%) / 18 (56.3%) / 4 (12.5%) / 1 (3.1%) | 1 (4.6%) / 5 (22.7%) / 13 (59.0%) / 2 (9.1%) / 1 (4.6%) | 1.000 |
CAT score (mean, SD) | 12.85 (5.04) | 12.78 (4.91) | 12.95 (5.33) | 0.852 |
GAP stage I / II / III (n, %) | 12 (22.2%) / 32 (59.3%) / 10 (18.5%) | 3 (9.4%) / 22 (68.7%) / 7 (21.9%) | 9 (40.9%) / 10 (45.5%) / 3 (13.6%) | 0.026 |
Japanese severity stage I / II / III / IV (n, %) | 9 (16.7%) / 25 (46.3%) / 18 (33.3%) / 2 (3.7%) | 7 (21.9%) / 14 (43.8%) / 10 (31.2%) / 1 (3.1%) | 2 (9.1%) / 11 (50.0%) / 8 (36.4%) / 1 (4.5%) | 0.357 |
Mean FVC (ml, range) | 2286.3 (770.0–3860.0) | 2252.2 (770.0–3710.0) | 2335.9 (1750.0–3860.0) | 0.846 |
Mean % FVC (%, range) | 72.2 (27.1–106.3) | 72.8 (27.1–106.3) | 71.8 (39.5–98.2) | 0.470 |
Honeycombing + / − (n, %) | 44 (81.5%) / 10 (18.5%) | 26 (81.2%) / 6 (18.8%) | 18 (81.8%) / 4 (18.2%) | 1.000 |
Emphysema + / − (n, %) | 26 (48.1%) / 28 (51.9%) | 14 (43.8%) / 18 (56.2%) | 12 (54.5%) / 10 (45.5%) | 0.580 |
Previous pirfenidone (n, %) | 12 (22.2%) | 7 (21.9%) | 5 (22.7%) | 1.000 |
Nintedanib starting dose 300 / 200mg (n, %) | 35 (64.8%) / 19 (35.2%) | 18 (56.2%) / 14 (43.8%) | 17 (77.3%) / 5 (22.7%) | 0.151 |
Total (n = 54) | ≥75 years (n = 32) | <75 years (n = 22) | p-value | |
---|---|---|---|---|
Subjective Improvement after 6 Months (n, %) | ||||
Elderly vs. Younger | 25 / 54 (46.3%) | 16 / 32 (50.0%) | 9 / 22 (40.9%) | 0.585 |
mMRC grade ≥ 1 point | 5 / 54 (9.26%) | 4 / 32 (12.5%) | 1 / 22 (4.55%) | 0.683 |
CAT score ≥ 3 points | 25 / 54 (46.3%) | 16 / 32 (50.0%) | 9 / 22 (40.9%) | 0.585 |
Honeycombing +/− ≥75y: n = 26 / 6, <75y: n = 18 / 4 | (+); 21 / 44 (47.7%) (−); 4 / 10 (40.0%) | (+); 13 / 26 (50.0%) (−); 3 / 6 (50.0%) | (+); 8 / 18 (44.4%) (−); 1 / 4 (25.0%) | 0.767 0.571 |
Emphysema +/− ≥75y: n = 14 / 18, <75y: n = 12 / 10 | (+); 14 / 26 (53.8%) (−); 11 / 28 (39.3%) | (+); 7 / 14 (50.0%) (−); 9 / 18 (50.0%) | (+); 7 / 12 (58.3%) (−); 2 / 10 (20.0%) | 0.713 0.226 |
Objective Improvement; Median ΔFVC%+6M (%, range) | ||||
Elderly vs. Younger | −1.42 (−11.4 – +12.2) | −1.18 (-11.1 – +12.1) | −1.64 (−11.4 – +12.2) | 0.398 |
Honeycombing +/− ≥75y: n = 26 / 6, <75y: n = 18 / 4 | −1.36 (−11.4 – +10.8), −2.21 (−11.1 – +12.2) | −0.67 (−11.1 – +10.8) / −6.63 (−11.0 – +12.1) | −1.68 (−11.4 – +6.40) / −2.04 (−11.1 – +12.2) | 1.000 |
Emphysema +/− ≥75y: n = 14/18, <75y: n = 12/10 | −1.42 (−11.4 – +12.2), −1.59 (−11.1 – +10.8) | −1.10 (−11.4 – +12.1) / −1.17 (−11.1 – +10.8) | −1.10 (−11.4 – +12.2) / −2.74 (−11.7 – +9.76) | 0.580 |
Subjective Improvement after 12 Months (n, %) | ||||
Elderly vs. Younger | 25 / 54 (46.3%) | 16 / 32 (50.0%) | 9 / 22 (40.9%) | 0.585 |
mMRC grade ≥ 1 point | 5 / 54 (9.26%) | 4 / 32 (12.5%) | 1 / 22 (4.55%) | 0.683 |
CAT score ≥ 3 points | 25 / 54 (46.3%) | 16 / 32 (50.0%) | 9 / 22 (40.9%) | 0.585 |
Honeycombing +/− ≥75y: n = 26 / 6, <75y: n = 18 / 4 | (+); 21 / 44 (47.7%) (−); 4 / 10 (40.0%) | (+); 13 / 26 (50.0%) (−); 3 / 6 (50.0%) | (+); 8 / 18 (44.4%) (−); 1 / 4 (25.0%) | 0.767 0.571 |
Emphysema +/− ≥75y: n = 14 / 18, <75y: n = 12 / 10 | (+); 14 / 26 (53.8%) (−); 11 / 28 (39.3%) | (+); 7 / 14 (50.0%) (−); 9 / 18 (50.0%) | (+); 7 / 12 (58.3%) (−); 2 / 10 (20.0%) | 0.713 0.226 |
Objective Improvement; Median ΔFVC%+12M (%, range) | ||||
Elderly vs. Younger | −2.66 (−11.7 – +9.76) | −1.36 (−11.6 – +9.55) | −2.89 (−11.7 – +9.76) | 0.360 |
Honeycombing +/− ≥75y: n = 26 / 6, <75y: n = 18 / 4 | −2.63 (−11.7 – +7.55), −2.66 (−6.61 – +9.76) | −1.94 (−11.6 – +7.84) / −4.08 (−6.61 – +9.55) | −2.51 (-11.7 – +5.91) / −1.63 (-5.75 – +9.76) | 1.000 |
Emphysema +/− ≥75y: n = 14 / 18,<75y: n = 12 / 10 | −2.67 (−11.7 – +9.76), −2.79 (−9.71 – +7.84) | −1.72 (−11.6 – +9.55) / −2.38 (−9.71 – +7.84) | −2.74 (-11.7 – +9.76) / −3.40 (-9.71 – −1.41) | 0.151 |
6-Month Evaluation | Stable or Improved ΔFVC+6M (n = 17) | Declined ΔFVC+6M (n = 37) | p-value |
mMRC grade ≥ 1 point mMRC grade < 1 point | 1 (5.9%) 16 (94.1%) | 4 (10.8%) 33 (89.2%) | 1.000 |
CAT score ≥ 3 points CAT score < 3 points | 14 (82.4%) 3 (17.6%) | 11 (29.7%) 26 (70.3%) | <0.001 |
12-Month Evaluation | Stable or Improved ΔFVC+12M (n = 13) | Declined ΔFVC+12M (n = 41) | |
mMRC grade ≥ 1 point mMRC grade < 1 point | 0 (0%) 13 (100%) | 5 (12.2% )36 (87.8%) | 0.321 |
CAT score ≥ 3 point sCAT score < 3 points | 10 (76.9%) 3 (23.1%) | 15 (36.6%) 26 (63.4%) | 0.023 |
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Takeda, T.; Kunimatsu, Y.; Tani, N.; Hashimoto, I.; Kurono, Y.; Hirose, K. Improvement in Subjective Symptoms and Tolerability in Response to Nintedanib Treatment in Elderly Patients with Idiopathic Pulmonary Fibrosis. J. Clin. Med. 2020, 9, 755. https://doi.org/10.3390/jcm9030755
Takeda T, Kunimatsu Y, Tani N, Hashimoto I, Kurono Y, Hirose K. Improvement in Subjective Symptoms and Tolerability in Response to Nintedanib Treatment in Elderly Patients with Idiopathic Pulmonary Fibrosis. Journal of Clinical Medicine. 2020; 9(3):755. https://doi.org/10.3390/jcm9030755
Chicago/Turabian StyleTakeda, Takayuki, Yusuke Kunimatsu, Nozomi Tani, Izumi Hashimoto, Yuri Kurono, and Kazuki Hirose. 2020. "Improvement in Subjective Symptoms and Tolerability in Response to Nintedanib Treatment in Elderly Patients with Idiopathic Pulmonary Fibrosis" Journal of Clinical Medicine 9, no. 3: 755. https://doi.org/10.3390/jcm9030755