Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 610-616 |
| Journal | Annals of the Rheumatic Diseases |
| Volume | 78 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 2019 |
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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 journal › Article › Academic › peer-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.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85062303147&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/30808625
U2 - 10.1136/annrheumdis-2018-214746
DO - 10.1136/annrheumdis-2018-214746
M3 - Article
VL - 78
SP - 610
EP - 616
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
SN - 0003-4967
IS - 5
ER -