Clinical, functional and radiographic consequences of achieving stable low disease activity and remission with adalimumab plus methotrexate or methotrexate alone in early rheumatoid arthritis: 26-week results from the randomised, controlled OPTIMA study.

Annals of the Rheumatic Diseases
Arthur KavanaughJosef S Smolen

Abstract

To assess the efficacy and safety of adalimumab plus methotrexate (ADA+MTX) compared with methotrexate monotherapy in achieving stable low disease activity (LDA; disease activity score (DAS28(CRP)) <3.2 at weeks 22 and 26) and clinical, radiographic and functional outcomes in methotrexate-naive patients with early rheumatoid arthritis (RA). 1032 patients with active RA were randomly assigned 1:1 to ADA+MTX or placebo plus methotrexate (PBO+MTX) for 26 weeks. Treatment modifications were to be made in a subsequent study period based on the achievement of DAS28(CRP) <3.2 at weeks 22 and 26. Post-hoc analyses compared patients achieving stable remission using DAS28 and 2010 ACR/EULAR criteria with those achieving LDA but not remission. Among patients completing 6 months, 44% (207/466) ADA+MTX versus 24% (112/460) PBO+MTX patients achieved stable LDA at weeks 22 and 26 (p<0.001). Combination therapy was statistically superior to methotrexate in obtaining higher ACR20/50/70 responses, more clinical remissions, greater mean reductions in DAS28(CRP), no radiographic progression, and normal functional status at week 26 (p<0.001 for all). The only factor predicting stable LDA was disease activity at week 12. Patients achieving ACR/EULAR...Continue Reading

References

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Jul 3, 2008·Annals of the Rheumatic Diseases·J S SmolenUNKNOWN Active-Controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset (ASPIRE) S
Mar 11, 2010·Annals of the Rheumatic Diseases·Josef S SmolenUNKNOWN T2T Expert Committee
Mar 17, 2011·Annals of the Rheumatic Diseases·M F BakkerUNKNOWN Utrecht Arthritis Cohort Study Group
Aug 23, 2011·Rheumatology·Noemí BusquetsUNKNOWN BIOBADASER 2.0 Study Group

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Citations

Dec 10, 2013·Best Practice & Research. Clinical Rheumatology·Jackie L Nam, Paul Emery
Feb 6, 2014·Clinical Rheumatology·Gabriella KádárLászló Kovács
Apr 11, 2013·Annals of the Rheumatic Diseases·J A B van NiesA H M van der Helm-van Mil
May 17, 2014·The European Journal of Health Economics : HEPAC : Health Economics in Prevention and Care·Petra BajiValentin Brodszky
Mar 13, 2014·Current Rheumatology Reports·Yong Gil Hwang, Larry W Moreland
Nov 6, 2014·The New England Journal of Medicine·Paul EmeryBonnie Vlahos
May 15, 2015·Annals of the Rheumatic Diseases·Josef S SmolenDesirée van der Heijde
Oct 31, 2013·Lancet·John R Kirwan, Maarten Boers
Feb 26, 2016·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Alberto MiglioreDavide Integlia
Dec 3, 2013·Clinical Therapeutics·Yoshiya Tanaka, Shintaro Hirata
Jun 11, 2015·Expert Opinion on Pharmacotherapy·Diederik De CockRené Westhovens
Apr 29, 2014·Expert Opinion on Investigational Drugs·Luca SemeranoMarie-Christophe Boissier
Feb 20, 2014·Annals of the Rheumatic Diseases·Gerd-Rudiger BurmesterRoy M Fleischmann
May 20, 2014·BioMed Research International·Ennio Giulio FavalliRoberto Caporali
Feb 18, 2015·Nature Reviews. Rheumatology·Josef S Smolen, Daniel Aletaha
Apr 10, 2015·Current Rheumatology Reports·Ana-Maria Orbai, Clifton O Bingham
Oct 26, 2013·Clinical Therapeutics·Iris Navarro-MillánJeffrey R Curtis
Feb 6, 2015·Wiener medizinische Wochenschrift·Helga Radner, Daniel Aletaha
Oct 30, 2016·Lancet·Josef S SmolenIain B McInnes
Apr 3, 2016·Annals of the Rheumatic Diseases·Josef S SmolenUNKNOWN European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)

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Clinical Trials Mentioned

NCT00420927

Software Mentioned

PREMIER
OPTIMA

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