Achieving remission in psoriatic arthritis by early initiation of TNF inhibition: A double-blind, randomised, placebo-controlled trial of golimumab plus methotrexate versus placebo plus methotrexate

Leonieke J. J. van Mens, Henriëtte M. de Jong, Inka Fluri, Michael T. Nurmohamed, Marleen G. H. van de Sande, Marc Kok, Arno W. R. van Kuijk, Dominique Baeten

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Abstract

Objectives Early initiation of effective treatment favours remission in rheumatoid arthritis, but it remains unknown if the same concept applies to psoriatic arthritis (PsA). Therefore, this study investigated whether the combination of golimumab plus methotrexate (MTX) as a first-line treatment is superior to MTX alone in inducing remission in PsA. Methods This investigator-initiated, multicentre, double-blind, randomised, placebo-controlled trial included 51 MTX and bDMARD-naive patients with PsA fulfilling the CASPAR criteria and with active disease at baseline (≥3 swollen joint count/tender joint count). Patients were randomised to golimumab (50 mg SC monthly)+MTX (n=26) (TNFi arm) or matched placebo+MTX (n=25) (MTX arm). MTX was started 15 mg/week and increased to 25 mg/week over 8 weeks. The primary endpoint was percentage of patients achieving Disease Activity Score (DAS) remission (<1.6) at week 22. Safety was assessed throughout the study. Results The primary efficacy endpoint was achieved by 81% in the TNFi arm versus 42 % in the MTX arm (p=0.004). This difference in DAS remission was already observed at week 8. A significant difference in favour of the golimumab+MTX arm at week 22 was also observed for other response criteria such as MDA, ACR20/50/70, disease measures and patient-reported outcomes. The occurrence rates of adverse event and treatment-emergent adverse event were similar in both arms. Conclusions In patients with early PsA, DAS remission at week 22 was almost doubled with golimumab+MTX versus MTX alone. This double-blind, randomised, placebo-controlled study supports the concept that early initiation of TNFi in patients with PsA favours remission. Trial registration number NCT01871649.
Original languageEnglish
Pages (from-to)610-616
JournalAnnals of the Rheumatic Diseases
Volume78
Issue number5
DOIs
Publication statusPublished - 2019

Cite this

@article{083d943caa014ee1bf709cd7c19cc600,
title = "Achieving remission in psoriatic arthritis by early initiation of TNF inhibition: A double-blind, randomised, placebo-controlled trial of golimumab plus methotrexate versus placebo plus methotrexate",
abstract = "Objectives Early initiation of effective treatment favours remission in rheumatoid arthritis, but it remains unknown if the same concept applies to psoriatic arthritis (PsA). Therefore, this study investigated whether the combination of golimumab plus methotrexate (MTX) as a first-line treatment is superior to MTX alone in inducing remission in PsA. Methods This investigator-initiated, multicentre, double-blind, randomised, placebo-controlled trial included 51 MTX and bDMARD-naive patients with PsA fulfilling the CASPAR criteria and with active disease at baseline (≥3 swollen joint count/tender joint count). Patients were randomised to golimumab (50 mg SC monthly)+MTX (n=26) (TNFi arm) or matched placebo+MTX (n=25) (MTX arm). MTX was started 15 mg/week and increased to 25 mg/week over 8 weeks. The primary endpoint was percentage of patients achieving Disease Activity Score (DAS) remission (<1.6) at week 22. Safety was assessed throughout the study. Results The primary efficacy endpoint was achieved by 81{\%} in the TNFi arm versus 42 {\%} in the MTX arm (p=0.004). This difference in DAS remission was already observed at week 8. A significant difference in favour of the golimumab+MTX arm at week 22 was also observed for other response criteria such as MDA, ACR20/50/70, disease measures and patient-reported outcomes. The occurrence rates of adverse event and treatment-emergent adverse event were similar in both arms. Conclusions In patients with early PsA, DAS remission at week 22 was almost doubled with golimumab+MTX versus MTX alone. This double-blind, randomised, placebo-controlled study supports the concept that early initiation of TNFi in patients with PsA favours remission. Trial registration number NCT01871649.",
author = "{van Mens}, {Leonieke J. J.} and {de Jong}, {Henri{\"e}tte M.} and Inka Fluri and Nurmohamed, {Michael T.} and {van de Sande}, {Marleen G. H.} and Marc Kok and {van Kuijk}, {Arno W. R.} and Dominique Baeten",
year = "2019",
doi = "10.1136/annrheumdis-2018-214746",
language = "English",
volume = "78",
pages = "610--616",
journal = "Annals of the Rheumatic Diseases",
issn = "0003-4967",
publisher = "BMJ Publishing Group",
number = "5",

}

Achieving remission in psoriatic arthritis by early initiation of TNF inhibition: A double-blind, randomised, placebo-controlled trial of golimumab plus methotrexate versus placebo plus methotrexate. / van Mens, Leonieke J. J.; de Jong, Henriëtte M.; Fluri, Inka; Nurmohamed, Michael T.; van de Sande, Marleen G. H.; Kok, Marc; van Kuijk, Arno W. R.; Baeten, Dominique.

In: Annals of the Rheumatic Diseases, Vol. 78, No. 5, 2019, p. 610-616.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Achieving remission in psoriatic arthritis by early initiation of TNF inhibition: A double-blind, randomised, placebo-controlled trial of golimumab plus methotrexate versus placebo plus methotrexate

AU - van Mens, Leonieke J. J.

AU - de Jong, Henriëtte M.

AU - Fluri, Inka

AU - Nurmohamed, Michael T.

AU - van de Sande, Marleen G. H.

AU - Kok, Marc

AU - van Kuijk, Arno W. R.

AU - Baeten, Dominique

PY - 2019

Y1 - 2019

N2 - Objectives Early initiation of effective treatment favours remission in rheumatoid arthritis, but it remains unknown if the same concept applies to psoriatic arthritis (PsA). Therefore, this study investigated whether the combination of golimumab plus methotrexate (MTX) as a first-line treatment is superior to MTX alone in inducing remission in PsA. Methods This investigator-initiated, multicentre, double-blind, randomised, placebo-controlled trial included 51 MTX and bDMARD-naive patients with PsA fulfilling the CASPAR criteria and with active disease at baseline (≥3 swollen joint count/tender joint count). Patients were randomised to golimumab (50 mg SC monthly)+MTX (n=26) (TNFi arm) or matched placebo+MTX (n=25) (MTX arm). MTX was started 15 mg/week and increased to 25 mg/week over 8 weeks. The primary endpoint was percentage of patients achieving Disease Activity Score (DAS) remission (<1.6) at week 22. Safety was assessed throughout the study. Results The primary efficacy endpoint was achieved by 81% in the TNFi arm versus 42 % in the MTX arm (p=0.004). This difference in DAS remission was already observed at week 8. A significant difference in favour of the golimumab+MTX arm at week 22 was also observed for other response criteria such as MDA, ACR20/50/70, disease measures and patient-reported outcomes. The occurrence rates of adverse event and treatment-emergent adverse event were similar in both arms. Conclusions In patients with early PsA, DAS remission at week 22 was almost doubled with golimumab+MTX versus MTX alone. This double-blind, randomised, placebo-controlled study supports the concept that early initiation of TNFi in patients with PsA favours remission. Trial registration number NCT01871649.

AB - Objectives Early initiation of effective treatment favours remission in rheumatoid arthritis, but it remains unknown if the same concept applies to psoriatic arthritis (PsA). Therefore, this study investigated whether the combination of golimumab plus methotrexate (MTX) as a first-line treatment is superior to MTX alone in inducing remission in PsA. Methods This investigator-initiated, multicentre, double-blind, randomised, placebo-controlled trial included 51 MTX and bDMARD-naive patients with PsA fulfilling the CASPAR criteria and with active disease at baseline (≥3 swollen joint count/tender joint count). Patients were randomised to golimumab (50 mg SC monthly)+MTX (n=26) (TNFi arm) or matched placebo+MTX (n=25) (MTX arm). MTX was started 15 mg/week and increased to 25 mg/week over 8 weeks. The primary endpoint was percentage of patients achieving Disease Activity Score (DAS) remission (<1.6) at week 22. Safety was assessed throughout the study. Results The primary efficacy endpoint was achieved by 81% in the TNFi arm versus 42 % in the MTX arm (p=0.004). This difference in DAS remission was already observed at week 8. A significant difference in favour of the golimumab+MTX arm at week 22 was also observed for other response criteria such as MDA, ACR20/50/70, disease measures and patient-reported outcomes. The occurrence rates of adverse event and treatment-emergent adverse event were similar in both arms. Conclusions In patients with early PsA, DAS remission at week 22 was almost doubled with golimumab+MTX versus MTX alone. This double-blind, randomised, placebo-controlled study supports the concept that early initiation of TNFi in patients with PsA favours remission. Trial registration number NCT01871649.

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UR - https://www.ncbi.nlm.nih.gov/pubmed/30808625

U2 - 10.1136/annrheumdis-2018-214746

DO - 10.1136/annrheumdis-2018-214746

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