Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis

Ronald F van Vollenhoven, Mikkel Østergaard, Marjatta Leirisalo-Repo, Till Uhlig, Marita Jansson, Esbjörn Larsson, Fiona Brock, Karin Franck-Larsson

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

BACKGROUND: The aim of the Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Patients Who Have Achieved a Stable Low Disease Activity-State study was to investigate the effect of etanercept (ETN) dose maintenance, reduction or withdrawal on patients with rheumatoid arthritis (RA) who had already achieved stable low disease activity (LDA) on ETN 50 mg+methotrexate (MTX).

METHODS: Patients with RA (n=91) and stable LDA with ETN 50 mg once weekly (QW)+MTX were included. After 8 weeks with unchanged treatment, 73 patients were randomised in a double-blind design to ETN 50 mg QW+MTX (ETN50), ETN 25 mg QW+MTX (ETN25) or placebo QW+MTX (PBO) for 48 weeks. Patients who flared were declared failures and treated with open-label ETN50 until week 48. The primary outcome was the proportion of patients on ETN50 versus PBO who were non-failures after 48 weeks.

RESULTS: The proportion of non-failure patients was significantly lower with ETN50 (52%; p=0.007) and ETN25 (44%; p=0.044) versus PBO (13%). Median time to failure was significantly shorter with PBO (6 weeks) compared with ETN50 (48 weeks; p=0.001) and ETN25 (36 weeks; p<0.001). The majority of patients who flared regained LDA with open-label ETN50 quickly. Adverse events were consistent with the known side effect profiles of these medications.

CONCLUSIONS: In patients with established RA who have achieved stable LDA on ETN50+MTX, continuing both is superior to PBO+MTX. Reduced dose ETN was also more effective than PBO in maintaining a favourable response, suggesting that a maintenance strategy with reduced dose ETN may be possible in a number of patients with established RA.

TRIAL REGISTRATION NUMBER: NCT00858780.

Original languageEnglish
Pages (from-to)52-8
Number of pages7
JournalAnnals of the Rheumatic Diseases
Volume75
Issue number1
DOIs
Publication statusPublished - Jan 2016

Cite this

van Vollenhoven, R. F., Østergaard, M., Leirisalo-Repo, M., Uhlig, T., Jansson, M., Larsson, E., ... Franck-Larsson, K. (2016). Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis. Annals of the Rheumatic Diseases, 75(1), 52-8. https://doi.org/10.1136/annrheumdis-2014-205726
van Vollenhoven, Ronald F ; Østergaard, Mikkel ; Leirisalo-Repo, Marjatta ; Uhlig, Till ; Jansson, Marita ; Larsson, Esbjörn ; Brock, Fiona ; Franck-Larsson, Karin. / Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis. In: Annals of the Rheumatic Diseases. 2016 ; Vol. 75, No. 1. pp. 52-8.
@article{521527321e7b47d8a88562780c042450,
title = "Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis",
abstract = "BACKGROUND: The aim of the Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Patients Who Have Achieved a Stable Low Disease Activity-State study was to investigate the effect of etanercept (ETN) dose maintenance, reduction or withdrawal on patients with rheumatoid arthritis (RA) who had already achieved stable low disease activity (LDA) on ETN 50 mg+methotrexate (MTX).METHODS: Patients with RA (n=91) and stable LDA with ETN 50 mg once weekly (QW)+MTX were included. After 8 weeks with unchanged treatment, 73 patients were randomised in a double-blind design to ETN 50 mg QW+MTX (ETN50), ETN 25 mg QW+MTX (ETN25) or placebo QW+MTX (PBO) for 48 weeks. Patients who flared were declared failures and treated with open-label ETN50 until week 48. The primary outcome was the proportion of patients on ETN50 versus PBO who were non-failures after 48 weeks.RESULTS: The proportion of non-failure patients was significantly lower with ETN50 (52{\%}; p=0.007) and ETN25 (44{\%}; p=0.044) versus PBO (13{\%}). Median time to failure was significantly shorter with PBO (6 weeks) compared with ETN50 (48 weeks; p=0.001) and ETN25 (36 weeks; p<0.001). The majority of patients who flared regained LDA with open-label ETN50 quickly. Adverse events were consistent with the known side effect profiles of these medications.CONCLUSIONS: In patients with established RA who have achieved stable LDA on ETN50+MTX, continuing both is superior to PBO+MTX. Reduced dose ETN was also more effective than PBO in maintaining a favourable response, suggesting that a maintenance strategy with reduced dose ETN may be possible in a number of patients with established RA.TRIAL REGISTRATION NUMBER: NCT00858780.",
keywords = "Adult, Aged, Antirheumatic Agents, Arthritis, Rheumatoid, Double-Blind Method, Drug Therapy, Combination, Etanercept, Female, Humans, Male, Methotrexate, Middle Aged, Recurrence, Severity of Illness Index, Treatment Outcome, Withholding Treatment, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",
author = "{van Vollenhoven}, {Ronald F} and Mikkel {\O}stergaard and Marjatta Leirisalo-Repo and Till Uhlig and Marita Jansson and Esbj{\"o}rn Larsson and Fiona Brock and Karin Franck-Larsson",
note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/",
year = "2016",
month = "1",
doi = "10.1136/annrheumdis-2014-205726",
language = "English",
volume = "75",
pages = "52--8",
journal = "Annals of the Rheumatic Diseases",
issn = "0003-4967",
publisher = "BMJ Publishing Group",
number = "1",

}

van Vollenhoven, RF, Østergaard, M, Leirisalo-Repo, M, Uhlig, T, Jansson, M, Larsson, E, Brock, F & Franck-Larsson, K 2016, 'Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis' Annals of the Rheumatic Diseases, vol. 75, no. 1, pp. 52-8. https://doi.org/10.1136/annrheumdis-2014-205726

Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis. / van Vollenhoven, Ronald F; Østergaard, Mikkel; Leirisalo-Repo, Marjatta; Uhlig, Till; Jansson, Marita; Larsson, Esbjörn; Brock, Fiona; Franck-Larsson, Karin.

In: Annals of the Rheumatic Diseases, Vol. 75, No. 1, 01.2016, p. 52-8.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis

AU - van Vollenhoven, Ronald F

AU - Østergaard, Mikkel

AU - Leirisalo-Repo, Marjatta

AU - Uhlig, Till

AU - Jansson, Marita

AU - Larsson, Esbjörn

AU - Brock, Fiona

AU - Franck-Larsson, Karin

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PY - 2016/1

Y1 - 2016/1

N2 - BACKGROUND: The aim of the Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Patients Who Have Achieved a Stable Low Disease Activity-State study was to investigate the effect of etanercept (ETN) dose maintenance, reduction or withdrawal on patients with rheumatoid arthritis (RA) who had already achieved stable low disease activity (LDA) on ETN 50 mg+methotrexate (MTX).METHODS: Patients with RA (n=91) and stable LDA with ETN 50 mg once weekly (QW)+MTX were included. After 8 weeks with unchanged treatment, 73 patients were randomised in a double-blind design to ETN 50 mg QW+MTX (ETN50), ETN 25 mg QW+MTX (ETN25) or placebo QW+MTX (PBO) for 48 weeks. Patients who flared were declared failures and treated with open-label ETN50 until week 48. The primary outcome was the proportion of patients on ETN50 versus PBO who were non-failures after 48 weeks.RESULTS: The proportion of non-failure patients was significantly lower with ETN50 (52%; p=0.007) and ETN25 (44%; p=0.044) versus PBO (13%). Median time to failure was significantly shorter with PBO (6 weeks) compared with ETN50 (48 weeks; p=0.001) and ETN25 (36 weeks; p<0.001). The majority of patients who flared regained LDA with open-label ETN50 quickly. Adverse events were consistent with the known side effect profiles of these medications.CONCLUSIONS: In patients with established RA who have achieved stable LDA on ETN50+MTX, continuing both is superior to PBO+MTX. Reduced dose ETN was also more effective than PBO in maintaining a favourable response, suggesting that a maintenance strategy with reduced dose ETN may be possible in a number of patients with established RA.TRIAL REGISTRATION NUMBER: NCT00858780.

AB - BACKGROUND: The aim of the Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Patients Who Have Achieved a Stable Low Disease Activity-State study was to investigate the effect of etanercept (ETN) dose maintenance, reduction or withdrawal on patients with rheumatoid arthritis (RA) who had already achieved stable low disease activity (LDA) on ETN 50 mg+methotrexate (MTX).METHODS: Patients with RA (n=91) and stable LDA with ETN 50 mg once weekly (QW)+MTX were included. After 8 weeks with unchanged treatment, 73 patients were randomised in a double-blind design to ETN 50 mg QW+MTX (ETN50), ETN 25 mg QW+MTX (ETN25) or placebo QW+MTX (PBO) for 48 weeks. Patients who flared were declared failures and treated with open-label ETN50 until week 48. The primary outcome was the proportion of patients on ETN50 versus PBO who were non-failures after 48 weeks.RESULTS: The proportion of non-failure patients was significantly lower with ETN50 (52%; p=0.007) and ETN25 (44%; p=0.044) versus PBO (13%). Median time to failure was significantly shorter with PBO (6 weeks) compared with ETN50 (48 weeks; p=0.001) and ETN25 (36 weeks; p<0.001). The majority of patients who flared regained LDA with open-label ETN50 quickly. Adverse events were consistent with the known side effect profiles of these medications.CONCLUSIONS: In patients with established RA who have achieved stable LDA on ETN50+MTX, continuing both is superior to PBO+MTX. Reduced dose ETN was also more effective than PBO in maintaining a favourable response, suggesting that a maintenance strategy with reduced dose ETN may be possible in a number of patients with established RA.TRIAL REGISTRATION NUMBER: NCT00858780.

KW - Adult

KW - Aged

KW - Antirheumatic Agents

KW - Arthritis, Rheumatoid

KW - Double-Blind Method

KW - Drug Therapy, Combination

KW - Etanercept

KW - Female

KW - Humans

KW - Male

KW - Methotrexate

KW - Middle Aged

KW - Recurrence

KW - Severity of Illness Index

KW - Treatment Outcome

KW - Withholding Treatment

KW - Journal Article

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1136/annrheumdis-2014-205726

DO - 10.1136/annrheumdis-2014-205726

M3 - Article

VL - 75

SP - 52

EP - 58

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

SN - 0003-4967

IS - 1

ER -