Background: Clinical practice guidelines for the treatment of idiopathic pulmonary fibrosis (IPF) currently recommend pirfenidone and nintedanib. However, there is a lack of evidence from head-tohead comparisons. Objectives: To perform a systematic review and network meta-analysis (NMA) to access the efficacy and tolerability of two new treatments for IPF, pirfenidone and nintedanib. Methods: Randomized controlled trials (RCTs) selection (CENTRAL, MEDLINE, Embase), data extraction, risk of bias analysis, and GRADE assessment were carried out by two authors separately. Direct estimates were calculated using standard pairwise meta-analysis. A Bayesian mixed treatment comparison approach for NMA estimates, with 95% confidence intervals (CI), was used to compare the treatments, calculating odds ratios (OR) and number needed to treat (NNTB) or harm (NNTH). Results: The NMA on 10 randomized controlled trials showed that each drug had a positive effect on percentage of forced vital capacity (FVC) decline 10% (pirfenidone OR ¼ 0.54 [95% CI ¼ 0.37-0.80], NNTB ¼ 9 [95% CI ¼ 7-22]; nintedanib OR ¼ 0.59 [95% CI ¼ 0.41-0.84], NNTB ¼ 9 [95% CI ¼ 6-23]), but no significant differences were noted when comparing pirfenidone and nintedanib with respect to acute exacerbations, mortality, and serious adverse events (FVC decline OR ¼ 0.91 [95% CI ¼ 0.45-2.03]) or dropouts (OR ¼ 0.75 [95% CI ¼ 0.33-1.27]). Nintedanib showed an effect on dropouts, OR ¼ 1.61 (1.13-2.28) and . Conclusions: Based on RCTs of 12 month duration in patients with IPF, a positive effect on FVC decline was noted for both treatments and on dropouts for nintedanib, but no significant differences were noted between treatments. ARTICLE HISTORY

s231 produced a statistically significant reduction over placebo in rTNSS (standardized mean difference [SMD]-0.390; 95% CI-0.476 to-0.303, p< 0.001) in both the short (less than 6 weeks) and long term (52 weeks or more). A greater improvement was also established in iTNSS (-0.360,-0.484 to-0.236, p< 0.001), rTOSS (-0.163,-0.293 to-0.033, p= 0.014), iTOSS (-0.165,-0.295 to-0.035, p= 0.013) and QoL (-0.322,-0.452 to-0.191, p< 0.001) in the short term. All effect sizes were greater than-0.5, indicating small changes according to Cohen's guidelines. The incidence of most adverse events with FFNS was similar to that with placebo, with the exception of epistaxis, which was more frequent with FFNS in both the short (FFNS 7%, placebo 4%, p= 0.004) and long term (FFNS 25%, placebo 13%, p< 0.001). ConClusions: FFNS in adults and adolescents with PAR resulted in statistically significant but not clinically relevant improvements in symptoms and QoL compared with placebo.

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Background/Objective AUGUSTUS trial demonstrated that, for patients with atrial fibrillation (AF) having acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI), an antithrombotic regimen with apixaban and P2Y12 resulted in less bleeding, fewer hospitalizations, and similar ischemic events than regimens including a vitamin K antagonist (VKA), aspirin, or both. This study objective was to evaluate long-term health and economic outcomes and the cost-effectiveness of apixaban over VKA, as a treatment option for patients with AF having ACS/PCI. Methods A lifetime Markov cohort model was developed comparing apixaban versus VKA across multiple treatment strategies (triple [with P2Y12 + aspirin] or dual [with P2Y12] therapy followed by monotherapy [apixaban or VKA]; triple followed by dual and then monotherapy; dual followed by monotherapy). The model adopted the Spanish healthcare perspective, with a 3-month cycle length and costs and health outcomes discounted at 3%. Results Treatment with apixaban resulted in total cost savings of €883 and higher life years (LYs) and quality-adjusted LYs (QALYs) per patient than VKA (net difference, LYs: 0.13; QALYs: 0.11). Bleeding and ischemic events (per 100 patients) were lower with apixaban than VKA (net difference, –13.9 and –1.8, respectively). Incremental net monetary benefit for apixaban was €3,041, using a willingness-to-pay threshold of €20,000 per QALY. In probabilistic sensitivity analysis, apixaban was dominant in the majority of simulations (92.6%), providing additional QALYs at lower costs than VKA. Conclusions Apixaban was a dominant treatment strategy than VKA from both the Spanish payer’s and societal perspectives, regardless of treatment strategy considered.