Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis: an open-label extension study
Background - Patients with idiopathic pulmonary fibrosis (IPF) treated with PRM-151, a recombinant human pentraxin 2 protein, in a phase 2 double-blind, randomised controlled trial had significantly reduced decline in percentage of predicted forced vital capacity (FVC) and stabilised 6-min walking d...
Gespeichert in:
| Hauptverfasser: | , , , , , , , , , , , , , , , , , |
|---|---|
| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
20 May 2019
|
| In: |
The lancet. Respiratory medicine
Year: 2019, Jahrgang: 7, Heft: 8, Pages: 657-664 |
| ISSN: | 2213-2619 |
| DOI: | 10.1016/S2213-2600(19)30172-9 |
| Online-Zugang: | Verlag, Volltext: https://doi.org/10.1016/S2213-2600(19)30172-9 Verlag, Volltext: http://www.sciencedirect.com/science/article/pii/S2213260019301729 
|
| Verfasserangaben: | Ganesh Raghu, Bernt van den Blink, Mark J Hamblin, A Whitney Brown, Jeffrey A Golden, Lawrence A Ho, Marlies S Wijsenbeek, Martina Vasakova, Alberto Pesci, Danielle E Antin-Ozerkis, Keith C Meyer, Michael Kreuter, Donna Moran, Hugues Santin-Janin, Francois Aubin, Geert-Jan Mulder, Renu Gupta, Luca Richeldi |
MARC
| LEADER | 00000caa a2200000 c 4500 | ||
|---|---|---|---|
| 001 | 1689522828 | ||
| 003 | DE-627 | ||
| 005 | 20230427063103.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 200206s2019 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/S2213-2600(19)30172-9 |2 doi | |
| 035 | |a (DE-627)1689522828 | ||
| 035 | |a (DE-599)KXP1689522828 | ||
| 035 | |a (OCoLC)1341303777 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 33 |2 sdnb | ||
| 100 | 1 | |a Raghu, Ganesh |e VerfasserIn |0 (DE-588)1186982365 |0 (DE-627)1666255513 |4 aut | |
| 245 | 1 | 0 | |a Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis |b an open-label extension study |c Ganesh Raghu, Bernt van den Blink, Mark J Hamblin, A Whitney Brown, Jeffrey A Golden, Lawrence A Ho, Marlies S Wijsenbeek, Martina Vasakova, Alberto Pesci, Danielle E Antin-Ozerkis, Keith C Meyer, Michael Kreuter, Donna Moran, Hugues Santin-Janin, Francois Aubin, Geert-Jan Mulder, Renu Gupta, Luca Richeldi |
| 264 | 1 | |c 20 May 2019 | |
| 300 | |a 8 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Gesehen am 06.02.2020 | ||
| 520 | |a Background - Patients with idiopathic pulmonary fibrosis (IPF) treated with PRM-151, a recombinant human pentraxin 2 protein, in a phase 2 double-blind, randomised controlled trial had significantly reduced decline in percentage of predicted forced vital capacity (FVC) and stabilised 6-min walking distance compared with placebo over a 28-week period. Here we report the 76-week results of an open-label extension study. - Methods - Patients who completed the 28-week double-blind period of the PRM-151-202 trial were eligible to participate in the open-label extension study. Patients previously enrolled in the PRM-151 group continued this treatment and those previously in the placebo group crossed over to PRM-151. All patients received PRM-151 in 28-week cycles with loading doses of 10 mg/kg by 60 min intravenous infusions on days 1, 3, and 5 in the first week of each cycle followed by one infusion of 10 mg/kg every 4 weeks. The primary objective of the open-label extension study was to assess the long-term safety and tolerability of PRM-151, which were assessed by analysing adverse events (AEs) up to week 76 in all patients who received at least one dose of PRM-151 during the open-label extension study. Exploratory efficacy analyses were done by assessing changes from baseline in percentage of predicted FVC and 6-min walking distance, with descriptive statistics to week 76 and with random-intercept mixed models to week 52. This study is registered with ClinicalTrials.gov, number NCT02550873, and with EudraCT, number 2014-004782-24. - Findings - Of 116 patients who completed the double-blind treatment period, 111 entered the open-label extension study (74 from the PRM-151 group and 37 from the placebo group). 84 (76%) of 111 patients received concomitant IPF therapy (pirfenidone n=55 or nintedanib n=29). AEs were consistent with long-term IPF sequelae. 31 (28%) patients had serious AEs. Those occurring in two or more patients were pneumonia (six [5%] of 111), IPF exacerbation (four [4%]), IPF progression (four [4%]), and chest pain (two [2%]). 21 (19%) patients had severe AEs, of which IPF exacerbation and IPF progression each occurred in two (2%) patients. Two (2%) patients experienced life-threatening AEs (one had pneumonia and one had small-cell lung cancer extensive stage). A persistent treatment effect was observed for PRM-151 in patients who continued treatment, with a decline in percentage of predicted FVC of −3·6% per year and in 6-min walking distance of −10·5 m per year at week 52. In patients who started PRM-151 during the open-label extension study, compared with the slopes for placebo, decline reduced for percentage of predicted FVC (from −8·7% per year in weeks 0-28 to −0·9% per year in weeks 28-52, p<0·0001) and 6-min walking distance (from −54·9 m per year to −3·5 m per year, p=0·0224). - Interpretation - Long-term treatment with PRM-151 was well tolerated and the effects on percentage of predicted FVC and 6-min walking distance were persistent on continuation and positive in patients who crossed over from placebo. These findings support further study of PRM-151 in larger populations of patients with IPF. - Funding - Promedior. | ||
| 700 | 1 | |a van den Blink, Bernt |e VerfasserIn |4 aut | |
| 700 | 1 | |a Hamblin, Mark J |e VerfasserIn |4 aut | |
| 700 | 1 | |a Brown, A Whitney |e VerfasserIn |4 aut | |
| 700 | 1 | |a Golden, Jeffrey A. |d 1961- |e VerfasserIn |0 (DE-588)1155446844 |0 (DE-627)1017745226 |0 (DE-576)501664963 |4 aut | |
| 700 | 1 | |a Ho, Lawrence A |e VerfasserIn |4 aut | |
| 700 | 1 | |a Wijsenbeek, Marlies S |e VerfasserIn |4 aut | |
| 700 | 1 | |a Vasakova, Martina |e VerfasserIn |4 aut | |
| 700 | 1 | |a Pesci, Alberto |e VerfasserIn |4 aut | |
| 700 | 1 | |a Antin-Ozerkis, Danielle E |e VerfasserIn |4 aut | |
| 700 | 1 | |a Meyer, Keith C |e VerfasserIn |4 aut | |
| 700 | 1 | |a Kreuter, Michael |d 1972- |e VerfasserIn |0 (DE-588)122645995 |0 (DE-627)082066795 |0 (DE-576)293362742 |4 aut | |
| 700 | 1 | |a Moran, Donna |e VerfasserIn |4 aut | |
| 700 | 1 | |a Santin-Janin, Hugues |e VerfasserIn |4 aut | |
| 700 | 1 | |a Aubin, Francois |e VerfasserIn |4 aut | |
| 700 | 1 | |a Mulder, Geert-Jan |e VerfasserIn |4 aut | |
| 700 | 1 | |a Gupta, Renu |d 1947- |e VerfasserIn |0 (DE-588)1145776833 |0 (DE-627)1005728070 |0 (DE-576)170195465 |4 aut | |
| 700 | 1 | |a Richeldi, Luca |e VerfasserIn |0 (DE-588)116026578X |0 (DE-627)1023418843 |0 (DE-576)505817535 |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t The lancet. Respiratory medicine |d Oxford : Elsevier, 2013 |g 7(2019), 8, Seite 657-664 |w (DE-627)737292180 |w (DE-600)2704917-6 |w (DE-576)379472759 |x 2213-2619 |7 nnas |a Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis an open-label extension study |
| 773 | 1 | 8 | |g volume:7 |g year:2019 |g number:8 |g pages:657-664 |g extent:8 |a Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis an open-label extension study |
| 856 | 4 | 0 | |u https://doi.org/10.1016/S2213-2600(19)30172-9 |x Verlag |x Resolving-System |3 Volltext |
| 856 | 4 | 0 | |u http://www.sciencedirect.com/science/article/pii/S2213260019301729 |x Verlag |3 Volltext |
| 951 | |a AR | ||
| 992 | |a 20200206 | ||
| 993 | |a Article | ||
| 994 | |a 2019 | ||
| 998 | |g 122645995 |a Kreuter, Michael |m 122645995:Kreuter, Michael |d 910000 |d 950000 |d 950900 |d 50000 |e 910000PK122645995 |e 950000PK122645995 |e 950900PK122645995 |e 50000PK122645995 |k 0/910000/ |k 1/910000/950000/ |k 2/910000/950000/950900/ |k 0/50000/ |p 12 | ||
| 999 | |a KXP-PPN1689522828 |e 3588535799 | ||
| BIB | |a Y | ||
| SER | |a journal | ||
| JSO | |a {"note":["Gesehen am 06.02.2020"],"recId":"1689522828","type":{"media":"Online-Ressource","bibl":"article-journal"},"title":[{"title_sort":"Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis","title":"Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis","subtitle":"an open-label extension study"}],"person":[{"display":"Raghu, Ganesh","role":"aut","roleDisplay":"VerfasserIn","given":"Ganesh","family":"Raghu"},{"roleDisplay":"VerfasserIn","role":"aut","given":"Bernt","display":"van den Blink, Bernt","family":"van den Blink"},{"given":"Mark J","roleDisplay":"VerfasserIn","role":"aut","display":"Hamblin, Mark J","family":"Hamblin"},{"family":"Brown","display":"Brown, A Whitney","role":"aut","roleDisplay":"VerfasserIn","given":"A Whitney"},{"family":"Golden","roleDisplay":"VerfasserIn","role":"aut","given":"Jeffrey A.","display":"Golden, Jeffrey A."},{"given":"Lawrence A","roleDisplay":"VerfasserIn","role":"aut","display":"Ho, Lawrence A","family":"Ho"},{"display":"Wijsenbeek, Marlies S","given":"Marlies S","roleDisplay":"VerfasserIn","role":"aut","family":"Wijsenbeek"},{"role":"aut","roleDisplay":"VerfasserIn","given":"Martina","display":"Vasakova, Martina","family":"Vasakova"},{"roleDisplay":"VerfasserIn","role":"aut","given":"Alberto","display":"Pesci, Alberto","family":"Pesci"},{"family":"Antin-Ozerkis","display":"Antin-Ozerkis, Danielle E","role":"aut","roleDisplay":"VerfasserIn","given":"Danielle E"},{"family":"Meyer","given":"Keith C","roleDisplay":"VerfasserIn","role":"aut","display":"Meyer, Keith C"},{"family":"Kreuter","display":"Kreuter, Michael","roleDisplay":"VerfasserIn","role":"aut","given":"Michael"},{"family":"Moran","display":"Moran, Donna","role":"aut","roleDisplay":"VerfasserIn","given":"Donna"},{"given":"Hugues","role":"aut","roleDisplay":"VerfasserIn","display":"Santin-Janin, Hugues","family":"Santin-Janin"},{"family":"Aubin","display":"Aubin, Francois","roleDisplay":"VerfasserIn","role":"aut","given":"Francois"},{"family":"Mulder","given":"Geert-Jan","roleDisplay":"VerfasserIn","role":"aut","display":"Mulder, Geert-Jan"},{"family":"Gupta","display":"Gupta, Renu","given":"Renu","roleDisplay":"VerfasserIn","role":"aut"},{"family":"Richeldi","display":"Richeldi, Luca","role":"aut","roleDisplay":"VerfasserIn","given":"Luca"}],"language":["eng"],"id":{"doi":["10.1016/S2213-2600(19)30172-9"],"eki":["1689522828"]},"name":{"displayForm":["Ganesh Raghu, Bernt van den Blink, Mark J Hamblin, A Whitney Brown, Jeffrey A Golden, Lawrence A Ho, Marlies S Wijsenbeek, Martina Vasakova, Alberto Pesci, Danielle E Antin-Ozerkis, Keith C Meyer, Michael Kreuter, Donna Moran, Hugues Santin-Janin, Francois Aubin, Geert-Jan Mulder, Renu Gupta, Luca Richeldi"]},"origin":[{"dateIssuedDisp":"20 May 2019","dateIssuedKey":"2019"}],"physDesc":[{"extent":"8 S."}],"relHost":[{"title":[{"partname":"Respiratory medicine","title_sort":"lancet","title":"The lancet"}],"language":["eng"],"disp":"Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis an open-label extension studyThe lancet. Respiratory medicine","origin":[{"publisherPlace":"Oxford","dateIssuedKey":"2013","dateIssuedDisp":"2013-","publisher":"Elsevier"}],"part":{"volume":"7","issue":"8","text":"7(2019), 8, Seite 657-664","year":"2019","extent":"8","pages":"657-664"},"recId":"737292180","note":["Gesehen am 01.04.14"],"type":{"bibl":"periodical","media":"Online-Ressource"},"pubHistory":["1.2013 -"],"id":{"eki":["737292180"],"zdb":["2704917-6"],"issn":["2213-2619"]},"titleAlt":[{"title":"The lancet <London> / Respiratory medicine"}]}]} | ||
| SRT | |a RAGHUGANESLONGTERMTR2020 | ||