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The Active Local Europe project is a platform of cities and municipalities that work together across borders in the field of sports and physical activity, to encourage their citizens to be active and to empower a sense of belonging. The planned duration of the project is from 1 January to 31 December The ultimate goal of the project is to create opportunities for cities and municipalities in the EU to give their citizens a feeling of belonging, in an open society, and to be healthy and happy.

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Active Local Europe. Professor Van Overstraetenplein 1. Our correspondence. Connect with us. Reasons for permanent pirfenidone discontinuation in the registry during follow-up included death in The remaining permanent pirfenidone discontinuations 4. Pirfenidone treatment was temporarily discontinued in Around one-quarter of the temporary discontinuations The remaining three-quarters of temporary discontinuations Temporary pirfenidone dose reductions occurred in ADRs were reported to be the reason for dose reduction in The remaining In the pirfenidone-treated population, at Month 0, mean percent predicted FVC was At Month 24, mean percent predicted FVC was Mean percent predicted DLco at Month 24 was When mean percent predicted FVC at each time point was calculated separately for patients who were alive at Month 24 and patients who had died by Month 24, lung function was largely stable in both groups over time, but patients who survived showed higher mean percent predicted FVC at each time point Additional file 1 : Figure S1.

Patients were included in the calculation if they had a lung function measurement available for the specified time point, regardless of whether they had a baseline measurement a , b. For mean changes in pulmonary function from Month 0, patients were included in the calculation for a time point if they had an FVC or DLco measurement available for that time point and a corresponding measurement at Month 0 c. The mean time from registry inclusion to categorical absolute decline in percent predicted FVC was In patients who did not experience a temporary dose reduction or pirfenidone discontinuation, the respective values were DLco carbon monoxide diffusing capacity, FVC forced vital capacity.

The time-to-death analysis conducted in the pirfenidone-treated population is presented in Fig. The mean time from registry inclusion to death was In patients with a temporary dose reduction or discontinuation of pirfenidone, the mean time from registry inclusion to death was In patients without a temporary dose reduction or pirfenidone discontinuation, the corresponding value was Time-to-event analysis, from registry inclusion, for patients who died pirfenidone-treated population.


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In order to analyze the effect of treatment initiation on loss of pulmonary function and to take into consideration the intrinsic variability of lung function tests, a slope analysis of the evolution of FVC was performed, comparing the slope before and after initiation of pirfenidone Fig. At the time of first pirfenidone treatment, the estimated percent predicted FVC was FVC forced vital capacity, SE standard error. In a sensitivity analysis including only patients with a known date of pirfenidone initiation Fig.

Unlike the strict inclusion and exclusion criteria employed in clinical trials, the PROOF registry did not exclude patients on the basis of disease severity, comorbidities, or prescribed medications. As a result, data from PROOF, as with other registries, can be considered to be more representative of clinical practice than data from clinical trials. A total of 28 patients were treated with nintedanib at any time during follow-up, of whom 26 had previously received pirfenidone. The high proportion of patients prescribed pirfenidone compared with nintedanib was largely driven by the fact that while pirfenidone was approved for the treatment of patients with IPF in Europe in , nintedanib was not approved until [ 4 , 5 ].

In Belgium, where the registry was primarily conducted, the prescribing of antifibrotics is limited to centers highly experienced in the clinical diagnosis and management of IPF and which have an experienced MDT available.

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In Luxembourg, nintedanib became available for any center to prescribe from June Mean time to a categorical decline in FVC or DLco was slightly longer in patients with uninterrupted pirfenidone treatment compared with patients who experienced a temporary dose reduction or discontinuation. It should be noted that comparisons between the pirfenidone-treated and non—pirfenidone-treated populations were not possible due to the low number of patients who had not been treated with pirfenidone five of whom had previously been treated with nintedanib.

The results of the slope analysis were unexpected, with the rate of annual FVC decline appearing to be slightly higher after the initiation of pirfenidone versus before treatment. One potential explanation is that because many patients initiated treatment prior to enrollment To explore this hypothesis further, a sensitivity analysis was performed including only patients with a known date of pirfenidone initiation, i.

As expected, in the sensitivity analysis, the estimated rate of FVC decline was reduced after the initiation of pirfenidone compared with the estimated rate of FVC decline calculated for prior to pirfenidone therapy. These findings suggest that the results of the slope analysis were indeed affected by the availability and accuracy of the data recorded prior to the PROOF registry, thus supporting the body of evidence showing that pirfenidone can significantly reduce FVC decline in patients with IPF.

In addition to providing information on disease progression, the PROOF registry is a source of European data characterizing other clinically important outcomes in patients with IPF, irrespective of their treatment. In the PROOF registry, among all patients enrolled, the mortality rate during the follow-up period of October to July was Since different IPF registries have different follow-up periods, it is not possible to directly compare clinical outcome findings. Acute exacerbations have been identified as an important outcome associated with an increased risk of mortality in patients with IPF [ 32 ].

A total of One of the difficulties in collecting data on acute exacerbations is the lack of a standardized definition. In , Collard et al.

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As well as being a frequent comorbidity, the presence of pulmonary hypertension may impact on the disease course and has been associated with a higher risk of mortality in patients with IPF [ 3 ]. As the symptoms of pulmonary hypertension overlap with those of IPF, many patients are not evaluated for pulmonary hypertension [ 34 , 35 ]. Indeed, the lack of standardized guidance, combined with the fact that many patients were not evaluated for pulmonary hypertension, may have resulted in an underestimation of the prevalence in the PROOF registry.

Among the patients in the PROOF registry treated with pirfenidone at any time during follow-up, In clinical practice, dose adjustments can be used to manage ADRs and support treatment persistence in patients with IPF treated with antifibrotics.

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There are several potential limitations of the PROOF registry [ 30 ] that should be considered when interpreting the longitudinal outcomes presented in this analysis. With the exception of eight patients, all patients were diagnosed with IPF prior to enrollment in the registry, therefore the diagnostic data may have been affected by recall bias and it is possible that enrollment was affected by selection bias. Enrollment and survival in the registry may also have been biased by the exclusion of patients enrolled in a clinical trial, who would be expected to have less severe disease and fewer comorbidities compared with those patients who were not eligible for a clinical trial.

The registry included a relatively small population of patients with IPF across a limited geographical area. Several planned analyses included patient numbers that were too low to warrant reporting e. Since initiation and follow-up of antifibrotic agents in Belgium are limited to centers with experience in the clinical diagnosis and management of IPF although this is not the case in Luxembourg , results from the PROOF registry may not be representative of populations of patients with IPF in different countries.

Moreover, diagnosis at a center with an experienced MDT present may not be representative of the real world. Some patients with IPF who have comorbid life-threatening conditions may not be referred to a center of excellence for the treatment of IPF due to concerns regarding treatment tolerability or a lack of licensed treatments; this may affect the comparison of results from the PROOF registry with other real-world patient populations. It is also possible that the high burden of comorbidities reported in the PROOF registry [ 30 ] may have affected patient survival.

Finally, the PROOF registry was not designed as a clinical trial and so comparisons between different treatments with respect to outcomes may not be possible; in addition, the number of patients who had not been treated with pirfenidone was too low for comparison with the pirfenidone-treated population.

Only 4. Qualified researchers may request access to individual patient-level data through the clinical study data request platform www. American Cancer Society. Accessed 16 July Google Scholar. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. European Medicines Agency.

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Summary of Product Characteristics - Esbriet pirfenidone. Summary of Product Characteristics - Ofev nintedanib. Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials. Eur Respir J. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis.

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N Engl J Med. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. Real-world experience with nintedanib in patients with idiopathic pulmonary fibrosis. Eur Res J. Eur Clin Respir J. Respir Res. Baseline characteristics of idiopathic pulmonary fibrosis: analysis from the Australian Idiopathic Pulmonary Fibrosis Registry. Poster number: Baseline characteristics of participants in the Pulmonary Fibrosis Foundation Patient Registry [abstract]. Health-related quality of life in idiopathic pulmonary fibrosis: data from the Australian IPF Registry. Disease progression in idiopathic pulmonary fibrosis with mild physiological impairment: analysis from the Australian IPF registry.

BMC Pulm Med. Fregonese L, Eichler I. The future of the development of medicines in idiopathic pulmonary fibrosis. BMC Med. A global registry for idiopathic pulmonary fibrosis: the time is now. Challenges in pulmonary fibrosis: the need for an international registry for idiopathic pulmonary fibrosis. Walking distance on 6-MWT is a prognostic factor in idiopathic pulmonary fibrosis.

Respir Med. Changes in clinical and physiologic variables predict survival in idiopathic pulmonary fibrosis.

Idiopathic pulmonary fibrosis: prognostic value of changes in physiology and six-minute-walk test. Demographics and healthcare utilization of patients with idiopathic pulmonary fibrosis IPF in a real-world setting: updated findings from patients in the PROOF registry [poster].

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Poster number: A Baseline clinical characteristics, comorbidities and prescribed medication in a real-world population of patients with idiopathic pulmonary fibrosis: the PROOF registry. Acute exacerbations of idiopathic pulmonary fibrosis. Acute exacerbation and decline in forced vital capacity are associated with increased mortality in idiopathic pulmonary fibrosis. Ann Am Thorac Soc. Acute exacerbation of idiopathic pulmonary fibrosis.

An International Working Group Report. Cardiac manifestations of idiopathic pulmonary fibrosis. Intractable Rare Dis Res. Idiopathic pulmonary fibrosis: effects and optimal management of comorbidities. Lancet Respir Med.