Cargando…

Long-term golimumab persistence: Five-year treatment retention data pooled from pivotal Phase III clinical trials in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

INTRODUCTION: Golimumab, a monoclonal antibody against tumor necrosis factor–α (TNF-α), is used widely for treatment of rheumatic diseases. Long-term persistence is an important factor influencing therapeutic benefit and is a surrogate measure of efficacy. We compared five-year golimumab treatment p...

Descripción completa

Detalles Bibliográficos
Autores principales: Weinstein, Cindy L. J., Meehan, Alan G., Lin, Jianxin, Briscoe, Steven D., Govoni, Marinella
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10640568/
https://www.ncbi.nlm.nih.gov/pubmed/37751000
http://dx.doi.org/10.1007/s10067-023-06760-z
_version_ 1785146655125798912
author Weinstein, Cindy L. J.
Meehan, Alan G.
Lin, Jianxin
Briscoe, Steven D.
Govoni, Marinella
author_facet Weinstein, Cindy L. J.
Meehan, Alan G.
Lin, Jianxin
Briscoe, Steven D.
Govoni, Marinella
author_sort Weinstein, Cindy L. J.
collection PubMed
description INTRODUCTION: Golimumab, a monoclonal antibody against tumor necrosis factor–α (TNF-α), is used widely for treatment of rheumatic diseases. Long-term persistence is an important factor influencing therapeutic benefit and is a surrogate measure of efficacy. We compared five-year golimumab treatment persistence across studies, indications, and lines of therapy using pooled data from pivotal golimumab Phase III clinical trials. METHODS: This post-hoc analysis evaluated use of golimumab administered subcutaneously (50 or 100 mg every four weeks) for up to five years in 2228 adult participants with rheumatoid arthritis (RA; GO-BEFORE, GO-AFTER, and GO-FORWARD studies), psoriatic arthritis (PsA; GO-REVEAL study), or ankylosing spondylitis (AS; GO-RAISE study). Retention rate differences were evaluated by study, indication, and line of therapy using log-rank tests, and probability of treatment persistence was estimated by Kaplan–Meier analysis. RESULTS: Golimumab retention rates at Year 5 were consistently high when used as 1(st)-line therapy (69.8%) and did not differ significantly across the three indications tested (p = 0.5106) or across 1(st)-line studies (p = 0.2327). Retention at Year 5 was better in participants using golimumab as 1(st)-line than in those using it as 2(nd)-line (41.6%) therapy. Participants on 2(nd)-line golimumab therapy had a longer disease duration (median 9.2 years versus 3.7 years) than those on 1(st)-line golimumab therapy. CONCLUSIONS: These data support the value of long-term golimumab therapy in patients with chronic, immune-mediated rheumatic diseases when used as 1(st)-line (RA, PsA, AS) or 2(nd)-line (RA) therapy. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10067-023-06760-z.
format Online
Article
Text
id pubmed-10640568
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-106405682023-11-14 Long-term golimumab persistence: Five-year treatment retention data pooled from pivotal Phase III clinical trials in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis Weinstein, Cindy L. J. Meehan, Alan G. Lin, Jianxin Briscoe, Steven D. Govoni, Marinella Clin Rheumatol Original Article INTRODUCTION: Golimumab, a monoclonal antibody against tumor necrosis factor–α (TNF-α), is used widely for treatment of rheumatic diseases. Long-term persistence is an important factor influencing therapeutic benefit and is a surrogate measure of efficacy. We compared five-year golimumab treatment persistence across studies, indications, and lines of therapy using pooled data from pivotal golimumab Phase III clinical trials. METHODS: This post-hoc analysis evaluated use of golimumab administered subcutaneously (50 or 100 mg every four weeks) for up to five years in 2228 adult participants with rheumatoid arthritis (RA; GO-BEFORE, GO-AFTER, and GO-FORWARD studies), psoriatic arthritis (PsA; GO-REVEAL study), or ankylosing spondylitis (AS; GO-RAISE study). Retention rate differences were evaluated by study, indication, and line of therapy using log-rank tests, and probability of treatment persistence was estimated by Kaplan–Meier analysis. RESULTS: Golimumab retention rates at Year 5 were consistently high when used as 1(st)-line therapy (69.8%) and did not differ significantly across the three indications tested (p = 0.5106) or across 1(st)-line studies (p = 0.2327). Retention at Year 5 was better in participants using golimumab as 1(st)-line than in those using it as 2(nd)-line (41.6%) therapy. Participants on 2(nd)-line golimumab therapy had a longer disease duration (median 9.2 years versus 3.7 years) than those on 1(st)-line golimumab therapy. CONCLUSIONS: These data support the value of long-term golimumab therapy in patients with chronic, immune-mediated rheumatic diseases when used as 1(st)-line (RA, PsA, AS) or 2(nd)-line (RA) therapy. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10067-023-06760-z. Springer International Publishing 2023-09-26 2023 /pmc/articles/PMC10640568/ /pubmed/37751000 http://dx.doi.org/10.1007/s10067-023-06760-z Text en © Merck & Co., Inc., Rahway, NJ, USA and its affiliates 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Article
Weinstein, Cindy L. J.
Meehan, Alan G.
Lin, Jianxin
Briscoe, Steven D.
Govoni, Marinella
Long-term golimumab persistence: Five-year treatment retention data pooled from pivotal Phase III clinical trials in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis
title Long-term golimumab persistence: Five-year treatment retention data pooled from pivotal Phase III clinical trials in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis
title_full Long-term golimumab persistence: Five-year treatment retention data pooled from pivotal Phase III clinical trials in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis
title_fullStr Long-term golimumab persistence: Five-year treatment retention data pooled from pivotal Phase III clinical trials in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis
title_full_unstemmed Long-term golimumab persistence: Five-year treatment retention data pooled from pivotal Phase III clinical trials in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis
title_short Long-term golimumab persistence: Five-year treatment retention data pooled from pivotal Phase III clinical trials in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis
title_sort long-term golimumab persistence: five-year treatment retention data pooled from pivotal phase iii clinical trials in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10640568/
https://www.ncbi.nlm.nih.gov/pubmed/37751000
http://dx.doi.org/10.1007/s10067-023-06760-z
work_keys_str_mv AT weinsteincindylj longtermgolimumabpersistencefiveyeartreatmentretentiondatapooledfrompivotalphaseiiiclinicaltrialsinpatientswithrheumatoidarthritispsoriaticarthritisandankylosingspondylitis
AT meehanalang longtermgolimumabpersistencefiveyeartreatmentretentiondatapooledfrompivotalphaseiiiclinicaltrialsinpatientswithrheumatoidarthritispsoriaticarthritisandankylosingspondylitis
AT linjianxin longtermgolimumabpersistencefiveyeartreatmentretentiondatapooledfrompivotalphaseiiiclinicaltrialsinpatientswithrheumatoidarthritispsoriaticarthritisandankylosingspondylitis
AT briscoestevend longtermgolimumabpersistencefiveyeartreatmentretentiondatapooledfrompivotalphaseiiiclinicaltrialsinpatientswithrheumatoidarthritispsoriaticarthritisandankylosingspondylitis
AT govonimarinella longtermgolimumabpersistencefiveyeartreatmentretentiondatapooledfrompivotalphaseiiiclinicaltrialsinpatientswithrheumatoidarthritispsoriaticarthritisandankylosingspondylitis