Adjuvant Oral Prednisone Has No Clinical Benefit in Nonresponsive pwCF
Cystic fibrosis (CF) is a genetic disorder that primarily affects the lungs and digestive system. One of the most common pulmonary complications in CF is a pulmonary exacerbation (PEx), which can lead to lung function decline and hospitalization. While antibiotics are the standard treatment for PExs in people with CF (pwCF), some may not respond to intravenous (IV) antibiotics alone. In these cases, oral prednisone has been used as an adjuvant treatment to improve lung function recovery rates during PExs. However, recent study findings published in the European Respiratory Journal indicate that adjuvant oral prednisone has no clinical benefit in nonresponsive pwCF.
Study Design and Methods
The randomized, double-blind, placebo-controlled trial aimed to evaluate the effectiveness of oral prednisone as an adjuvant treatment in nonresponsive pwCF during a PEx. The study enrolled 173 patients from 14 CF centers across Canada between April 2017 and December 2022, who were at least 6 years of age and had experienced a relative drop in forced expiratory volume in 1 second (FEV1) by at least 10% from their baseline levels. Patients at risk for steroid-related complications were excluded.
Among the participants who did not recover more than 90% baseline predicted ppFEV1 after 7 days of IV antibiotics, 76 were randomly assigned either oral prednisone or placebo for 7 days. The primary outcome of the study was the proportion of patients who recovered more than 90% baseline ppFEV1 at day-14 of IV antibiotic therapy. The secondary outcome was ppFEV1 recovery rates at day 30 after antibiotic initiation.
The results showed that adjuvant oral prednisone had no significant clinical benefit in nonresponsive pwCF. Lung function recovery rates 30 days after antibiotic initiation were 48% in the prednisone group vs 55% in the placebo group. Additionally, both groups had a median of 15 total hospitalization days. On day 14 of IV antibiotics, 50% of patients in the prednisone group recovered baseline FEV1 vs 39% of patients in the placebo group (11% difference; P =. 34). From day 7 to day 14, the mean (SD) change in ppFEV1 in the prednisone group was 6. 8% (8. 8) predicted and 4. 6% (6. 9) predicted in the placebo group (mean difference, 2. 2% predicted; P =. 24). Neither group saw a statistically significant change in ppFEV1 from day 7 to either day 14 or to day 30. Also, the patients treated with prednisone compared with placebo did not experience a longer time to subsequent exacerbation (hazard ratio, 0. 83; 95% CI, 0. 45-1. 53; P =. 54).
Limitations and Conclusion
One of the main limitations of the study is the underpowered sample size, which affects the generalizability of the findings. Additionally, because fewer than 10% of participants were on CF transmembrane conductance regulator therapy, the generalizability of the findings is further limited. Despite these limitations, the researchers concluded that “this study failed to detect a difference in ppFEV1 recovery between adjuvant oral prednisone and placebo treatment in pwCF not responding at day 7 of IV antibiotic therapy for PExs. This randomized controlled trial did not demonstrate any clinical benefit of adjuvant prednisone in people with cystic fibrosis not responding to antibiotic treatment of a pulmonary exacerbation.”
Key Takeaways
- Adjuvant oral prednisone has been used as a treatment to improve lung function recovery rates during a PEx in nonresponsive pwCF.
- A recent randomized controlled trial showed that adjuvant oral prednisone had no clinical benefit in nonresponsive pwCF who have undergone IV antibiotic therapy for PExs.
- The study enrolled 173 participants who were randomized to receive either adjuvant oral prednisone or placebo.
- The study results indicate that adjuvant oral prednisone has no significant clinical benefit in nonresponsive pwCF.
- Study limitations include the small sample size and lack of generalizability.
Originally Post From https://www.pulmonologyadvisor.com/news/antibiotic-nonresponsive-cf-not-aided-by-prednisone/
