A Real-World Multicenter Retrospective Observational Study on Polish Experience with Nintedanib Therapy in Patients with Idiopathic Pulmonary Fibrosis: The PolExNIB Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Population
2.2. Data Collection
2.3. Statistical Analysis
3. Results
3.1. Baseline Characteristics
3.2. Tolerability, Safety, and Drug Persistence
3.3. Efficacy
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Number of Patients, n (%) | 501 (100) |
---|---|
City of Bydgoszcz, n (%) | 26 (5.2) |
City of Cracow (2 centers), n (%) | 57 (11.4) |
City of Gdansk, n (%) | 36 (7.2) |
City of Katowice, n (%) | 13 (2.6) |
City of Lodz (2 centers), n (%) | 55 (11) |
City of Lublin, n (%) | 22 (4.3) |
City of Olsztyn, n (%) | 23 (4.6) |
City of Poznan (2 centers), n (%) | 61 (12.2) |
City of Szczecin, n (%) | 25 (5) |
City of Warsaw (2 centers), n (%) | 114 (22.7) |
City of Zabrze, n (%) | 49 (9.8) |
City of Zielona Gora, n (%) | 20 (4) |
Sex, male/female, n (%) | 349 (69.66)/152 (30.34) |
Age (years), median (IQR) | 70.9 (65–75.7) |
Smoking history | |
Never smokers, n (%) | 134 (26.7) |
Former smokers, n (%) | 326 (65.1) |
Active smokers, n (%) | 41 (8.1) |
Pack-years, median (IQR) | 28 (20–40) |
Comorbidities | |
Hypertension, n (%) | 313 (62.5) |
Hyperlipidemia, n (%) | 186 (37.1) |
Coronary artery disease, n (%) | 128 (25.5) |
History of myocardial infarction, n (%) | 65 (13) |
Atrial fibrillation, n (%) | 32 (6.4) |
Heart failure, n (%) | 66 (13.2) |
Pulmonary hypertension, n (%) | 60 (12) |
Gastroesophageal reflux disease, n (%) | 134 (26.7) |
Diabetes, n (%) | 134 (26.7) |
Emphysema, n (%) | 106 (21.2) |
Depression, n (%) | 52 (10.4) |
Obstructive sleep apnea, n (%) | 32 (6.4) |
Benign prostate hypertrophy, n (%) | 96 (19.2) |
Neoplastic disease history, n (%) | 55 (11) |
Osteoarthritis, n (%) | 149 (29.8) |
Hypothyroidism, n (%) | 46 (9.2) |
Concomitant medications | |
Antihypertensive drugs, n (%) | 330 (65.9) |
Acetylsalicylic acid monotherapy, n (%) | 160 (31.9) |
Anticoagulants, n (%) | 34 (6.8) |
Acetylsalicylic acid + anticoagulant therapy, n (%) | 9 (1.8) |
Proton-pump inhibitors, n (%) | 163 (32.5) |
Statins, n (%) | 205 (40.9) |
Antidiabetic medications, n (%) | 116 (23.1) |
HRCT pattern | |
Radiologic UIP pattern, n (%) | 419 (83.6) |
Radiologic probable UIP pattern (%) | 68 (13.6) |
Radiologic inconsistent for UIP pattern, n (%) | 12 (2.4) |
Lung biopsy procedures | |
TBLC, n (%) | 18 (3.6) |
SLB, n (%) | 38 (7.6) |
BAL procedure, n (%) | 102 (20.7) |
Time from first symptoms to diagnosis (months), median (IQR) | 12 (6–28) |
Time from diagnosis to start of nintedanib therapy (months), median (IQR) | 3 (1–11) |
Pulmonary function | |
FVC (l), median (IQR) | 2.8 (2.3–3.5) |
FVC (% of predicted), median (IQR) | 80.2 (68.5–95) |
TLCO (mmol/min/kPa), median (IQR) | 4.1 (3.2–5.3) |
TLCO (% of predicted), median (IQR) | 55.9 (42.2–69) |
Blood oxygenation | |
SpO2 at rest (%), median (IQR) | 94 (91–96) |
6MWT (n = 288) | |
Distance (meters), mean (SD) | 436.8 (102.3) |
Desaturation, (∆%), median (IQR) | 5 (2–8) |
GAP score, median (IQR) | 3 (3–4) |
GAP index | |
Stage I, n (%) | 294 (58.9) |
Stage II, n (%) | 178 (35.7) |
Stage III, n (%) | 27 (5.4) |
Oxygen therapy | |
Home oxygen therapy, n (%) | 69 (13.8) |
Portable sources of oxygen, n (%) | 26 (5.2) |
IPF treatment in the past before initiation of nintedanib | |
No treatment, n (%) | 377 (75.2) |
Pirfenidone, n (%) | 88 (17.6) |
CS, n (%) | 41 (8.2) |
NAC, n (%) | 1 (0.2) |
CS + NAC + AZA, n (%) | 4 (0.8) |
Clinical trial, n (%) | 7 (1.4) |
Full dose treatment 150 mg b.i.d., n (%) | 334 (66.7) |
Reduced dose treatment 100 mg b.i.d., n (%) | 167 (33.3) |
Intermittent drug interruption and/or dose reduction, n (%) | 101 (20.2) |
ADRs | |
Diarrhea, n (%) | 227 (45.3) |
Nausea, n (%) | 104 (20.8) |
Vomiting, n (%) | 41 (8.2) |
Abdominal discomfort, n (%) | 148 (29.5) |
Decreased appetite, n (%) | 150 (29.9) |
Weight, n (%) | 161 (32.1) |
Fatigue, n (%) | 96 (19.2) |
Increased levels of AST/ALT, n (%) | 77 (15.4) |
Hepatotoxicity AST/ALT > 3 ULN, n (%) | 31 (6.2) |
Bleeding, n (%) | 20 (4) |
Nintedanib exposure, (months), median (IQR) | 15 (7–25.5) |
Reasons for treatment discontinuation | |
ADRs, n (%) | 51 (10.2) |
Disease progression, n (%) | 23 (4.6) |
Death, n (%) | 58 (11.6) |
Patient’s decision, n (%) | 33 (6.6) |
Lung transplantation, n (%) | 2 (0.4) |
Neoplastic disease, n (%) | 11 (2.2) |
Other, n (%) | 25 (5) |
0–6 Months | 6–12 Months | 12–18 Months | 18–24 Months | 24–30 Months | 30–36 Months | |
---|---|---|---|---|---|---|
∆FVC% | −0.96 (−4.94–3.51) | −0.8 (−4.9–2.84) | −0.7 (−5.24–2.89) | −0.9 (−4.8–2.99) | −2.05 (−5.37–1.68) | −1.22 (−5.86–2.86) |
∆TLCO% | −3.18 (−9.69–1.32) | −1.8 (−6.02–2.29) | −1.35 (−6.2–2.17) | −2.04 (−7.09–1.37) | −0.32 (−6.91–2.9) | −2.18 (−7.28–0.84) |
p 6–12 vs. 0–6 | p 12–18 vs. 0–6 | p 18–24 vs. 0–6 | p 24–30 vs. 0–6 | p 30–36 vs. 0–6 | ||
∆FVC% | 0.33 | 0.18 | 0.25 | 0.07 | 0.7 | |
∆TLCO% | 0.24 | 0.18 | 0.83 | 0.11 | 0.89 |
0–6 Months | 6–12 Months | 12–18 Months | 18–24 Months | 24–30 Months | 30–36 Months | |
---|---|---|---|---|---|---|
∆FVC% | ||||||
Significant improvement (∆FVC > 10%), n (%) | 28 (8.3) | 19 (7.4) | 14 (7.2) | 6 (4.6) | 1 (1.5) | 0 (0) |
Marginal improvement (10% ≥ ∆FVC > 5%), n (%) | 38 (11.3) | 25 (9.8) | 17 (8.7) | 14 (10.8) | 3 (4.5) | 1 (4.2) |
Stabilization (+5% ≥ ∆FVC > −5%), n (%) | 191 (56.8) | 149 (58.2) | 113 (58.0) | 80 (62.0) | 45 (68.2) | 17 (70.8) |
Marginal decline (−5% ≥ ∆FVC > −10%), n (%) | 48 (14.2) | 45 (17.6) | 35 (17.9) | 21 (16.3) | 14 (21.2) | 3 (12.5) |
Significant decline (∆FVC ≤ −10%), n (%) | 31 (9.2) | 18 (7.0) | 16 (8.2) | 8 (6.2) | 3 (4.5) | 3 (12.5) |
n | 336 | 256 | 195 | 129 | 66 | 24 |
∆TLCO% | ||||||
Significant improvement (∆TLCO > 15%), n (%) | 17 (5.4) | 18 (7.6) | 12 (6.6) | 4 (3.2) | 1 (1.6) | 0 (0) |
Stabilization (+15% ≥ ∆TLCO > −15%), n (%) | 250 (79.1) | 200 (84) | 160 (87.4) | 111 (90.2) | 59 (93.6) | 24 (96) |
Significant decline (∆TLCO ≤ −15%), n (%) | 49 (15.5) | 20 (8.4) | 11 (6.0) | 8 (6.5) | 3 (4.8) | 1 (4) |
n | 316 | 238 | 183 | 123 | 63 | 25 |
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Majewski, S.; Białas, A.J.; Barczyk, A.; Batura-Gabryel, H.; Buchczyk, M.; Doboszyńska, A.; Górska, K.; Grabowska-Skudlarz, L.; Jagielska-Len, H.; Jarzemska, A.; et al. A Real-World Multicenter Retrospective Observational Study on Polish Experience with Nintedanib Therapy in Patients with Idiopathic Pulmonary Fibrosis: The PolExNIB Study. J. Clin. Med. 2023, 12, 4635. https://doi.org/10.3390/jcm12144635
Majewski S, Białas AJ, Barczyk A, Batura-Gabryel H, Buchczyk M, Doboszyńska A, Górska K, Grabowska-Skudlarz L, Jagielska-Len H, Jarzemska A, et al. A Real-World Multicenter Retrospective Observational Study on Polish Experience with Nintedanib Therapy in Patients with Idiopathic Pulmonary Fibrosis: The PolExNIB Study. Journal of Clinical Medicine. 2023; 12(14):4635. https://doi.org/10.3390/jcm12144635
Chicago/Turabian StyleMajewski, Sebastian, Adam J. Białas, Adam Barczyk, Halina Batura-Gabryel, Małgorzata Buchczyk, Anna Doboszyńska, Katarzyna Górska, Luiza Grabowska-Skudlarz, Hanna Jagielska-Len, Agnieszka Jarzemska, and et al. 2023. "A Real-World Multicenter Retrospective Observational Study on Polish Experience with Nintedanib Therapy in Patients with Idiopathic Pulmonary Fibrosis: The PolExNIB Study" Journal of Clinical Medicine 12, no. 14: 4635. https://doi.org/10.3390/jcm12144635