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Structural damage progression in patients with early rheumatoid arthritis treated with methotrexate, baricitinib, or baricitinib plus methotrexate based on clinical response in the phase 3 RA-BEGIN study.

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van der Heijde, Désirée Durez, Patrick [UCL] Schett, Georg Naredo, Esperanza Østergaard, Mikkel Fleischmann, Roy

The objective of this study was to evaluate structural damage progression based on clinical response in rheumatoid arthritis patients with no or limited prior disease-modifying anti-rheumatic drug treatment receiving the Janus kinase (JAK)1/JAK2 inhibitor baricitinib 4 mg, methotrexate (MTX), or the combination. Data from the phase 3 RA-BEGIN study were analysed post hoc. Proportions of patients with structural damage progression (change from baseline greater than the smallest detectable change in modified total Sharp score) at week 52 were evaluated based on sustained Disease Activity Score for 28-joint count with serum high-sensitivity C-reactive protein (DAS28-hsCRP) ≤ 3.2 or Simplified Disease Activity Index (SDAI) score ≤ 11; no formal statistical comparisons between treatments were performed to test these proportions. Baseline factors associated with risk of structural damage progression, including Clinical Disease Activity Index (CDAI) score, were identified using multivariate analysis. Patients achieving versus not achieving sustained DAS28-hsCRP ≤ 3.2 or SDAI score ≤ 11 were less likely to experience structural damage progression at week 52. In patients achieving these responses, structural damage progression was less likely with baricitinib monotherapy or plus MTX than with MTX monotherapy. In patients not achieving these sustained clinical thresholds, structural damage progression was less likely with baricitinib plus MTX than with either monotherapy. Independent of treatment, baseline factors significantly associated with increased risk of structural damage progression included higher hsCRP and CDAI score, smoking, female sex, and lower body mass index. In conclusion, patients achieving versus not achieving sustained DAS28-hsCRP ≤ 3.2 or SDAI score ≤ 11 were less likely to show structural damage progression, irrespective of treatment.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès libre
Publication date 2018
Language Anglais
Journal information "Clinical Rheumatology" - Vol. 37, no.9, p. 2381-2390 (2018)
Peer reviewed yes
Publisher Springer ((Germany) Heidelberg )
issn 0770-3198
e-issn 1434-9949
Publication status Publié
Affiliations UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales
UCL - (SLuc) Service de rhumatologie
MESH Subject Antirheumatic Agents ; Arthritis, Rheumatoid ; Azetidines ; C-Reactive Protein ; Disease Progression ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Humans ; Male ; Methotrexate ; Middle Aged ; Odds Ratio ; Sulfonamides ; Treatment Outcome
Keywords Baricitinib ; Joint damage ; Methotrexate ; RA-BEGIN study ; Rheumatoid arthritis ; Structural progression
Links
  1. van den Broek Marianne, Dirven Linda, Kroon Herman M., Kloppenburg Margreet, Ronday H. Karel, Peeters André J., Kerstens Pit J.S.M., Huizinga Tom W.J., Lems Willem F., Allaart Cornelia F., Early Local Swelling and Tenderness Are Associated with Large-joint Damage After 8 Years of Treatment to Target in Patients with Recent-onset Rheumatoid Arthritis, 10.3899/jrheum.121248
  2. Mellado Mario, T cell migration in rheumatoid arthritis, 10.3389/fimmu.2015.00384
  3. McInnes Iain B, Liew Foo Y, Cytokine networks—towards new therapies for rheumatoid arthritis, 10.1038/ncprheum0020
  4. McInnes Iain B., Schett Georg, The Pathogenesis of Rheumatoid Arthritis, 10.1056/nejmra1004965
  5. Bonilla-Hernan M. G., Miranda-Carus M. E., Martin-Mola E., New drugs beyond biologics in rheumatoid arthritis: the kinase inhibitors, 10.1093/rheumatology/ker192
  6. Fridman Jordan S., Scherle Peggy A., Collins Robert, Burn Timothy C., Li Yanlong, Li Jun, Covington Maryanne B., Thomas Beth, Collier Paul, Favata Margaret F., Wen Xiaoming, Shi Jack, McGee Ryan, Haley Patrick J., Shepard Stacey, Rodgers James D., Yeleswaram Swamy, Hollis Greg, Newton Robert C., Metcalf Brian, Friedman Steven M., Vaddi Kris, Selective Inhibition of JAK1 and JAK2 Is Efficacious in Rodent Models of Arthritis: Preclinical Characterization of INCB028050, 10.4049/jimmunol.0902819
  7. Olumiant 2 mg and 4 mg film-coated tablets. SPC. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004085/WC500223723.pdf . Accessed 11 April 2018
  8. Olumiant (baricitinib) tablets, for oral use. Prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207924s000lbl.pdf Accessed 21 June 2018
  9. Fleischmann Roy, Schiff Michael, van der Heijde Désirée, Ramos-Remus Cesar, Spindler Alberto, Stanislav Marina, Zerbini Cristiano A. F., Gurbuz Sirel, Dickson Christina, de Bono Stephanie, Schlichting Douglas, Beattie Scott, Kuo Wen-Ling, Rooney Terence, Macias William, Takeuchi Tsutomu, Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease-Modifying Antirheumatic Drug Treatment : BARICITINIB IN PATIENTS WITH EARLY RHEUMATOID ARTHRITIS, 10.1002/art.39953
  10. Taylor Peter C., Keystone Edward C., van der Heijde Désirée, Weinblatt Michael E., del Carmen Morales Liliana, Reyes Gonzaga Jaime, Yakushin Sergey, Ishii Taeko, Emoto Kahaku, Beattie Scott, Arora Vipin, Gaich Carol, Rooney Terence, Schlichting Douglas, Macias William L., de Bono Stephanie, Tanaka Yoshiya, Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis, 10.1056/nejmoa1608345
  11. Dougados Maxime, van der Heijde Désirée, Chen Ying-Chou, Greenwald Maria, Drescher Edit, Liu Jiajun, Beattie Scott, Witt Sarah, de la Torre Inmaculada, Gaich Carol, Rooney Terence, Schlichting Douglas, de Bono Stephanie, Emery Paul, Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study, 10.1136/annrheumdis-2016-210094
  12. Genovese Mark C., Kremer Joel, Zamani Omid, Ludivico Charles, Krogulec Marek, Xie Li, Beattie Scott D., Koch Alisa E., Cardillo Tracy E., Rooney Terence P., Macias William L., de Bono Stephanie, Schlichting Douglas E., Smolen Josef S., Baricitinib in Patients with Refractory Rheumatoid Arthritis, 10.1056/nejmoa1507247
  13. van der Heijde D (1999) How to read radiographs according to the sharp/van der Heijde method. J Rheumatol 26:743–745
  14. van der Heijde D, Boers M, Lassere M (1999) Methodological issues in radiographic scoring methods in rheumatoid arthritis. J Rheumatol 26:726–730
  15. Bruynesteyn K, Deciding on progression of joint damage in paired films of individual patients: smallest detectable difference or change, 10.1136/ard.2003.018457
  16. Fleischmann Roy, van der Heijde Désirée, Koenig Andrew S, Pedersen Ronald, Szumski Annette, Marshall Lisa, Bananis Eustratios, How much does Disease Activity Score in 28 joints ESR and CRP calculations underestimate disease activity compared with the Simplified Disease Activity Index?, 10.1136/annrheumdis-2013-204920
  17. Fleischmann Roy M, van der Heijde Désirée, Gardiner Philip V, Szumski Annette, Marshall Lisa, Bananis Eustratios, DAS28-CRP and DAS28-ESR cut-offs for high disease activity in rheumatoid arthritis are not interchangeable, 10.1136/rmdopen-2016-000382
  18. Anderson Jaclyn, Caplan Liron, Yazdany Jinoos, Robbins Mark L., Neogi Tuhina, Michaud Kaleb, Saag Kenneth G., O'dell James R., Kazi Salahuddin, Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice : ACR RA Disease Activity Measures Recommendations, 10.1002/acr.21649
  19. Singh JA, Saag KG, Bridges SL et al (2016) 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol 68:1–26
  20. Smolen Josef S, Landewé Robert, Bijlsma Johannes, Burmester Gerd, Chatzidionysiou Katerina, Dougados Maxime, Nam Jackie, Ramiro Sofia, Voshaar Marieke, van Vollenhoven Ronald, Aletaha Daniel, Aringer Martin, Boers Maarten, Buckley Chris D, Buttgereit Frank, Bykerk Vivian, Cardiel Mario, Combe Bernard, Cutolo Maurizio, van Eijk-Hustings Yvonne, Emery Paul, Finckh Axel, Gabay Cem, Gomez-Reino Juan, Gossec Laure, Gottenberg Jacques-Eric, Hazes Johanna M W, Huizinga Tom, Jani Meghna, Karateev Dmitry, Kouloumas Marios, Kvien Tore, Li Zhanguo, Mariette Xavier, McInnes Iain, Mysler Eduardo, Nash Peter, Pavelka Karel, Poór Gyula, Richez Christophe, van Riel Piet, Rubbert-Roth Andrea, Saag Kenneth, da Silva Jose, Stamm Tanja, Takeuchi Tsutomu, Westhovens René, de Wit Maarten, van der Heijde Désirée, EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update, 10.1136/annrheumdis-2016-210715
  21. Aletaha Daniel, Ward Michael M., Machold Klaus P., Nell Valerie P. K., Stamm Tanja, Smolen Josef S., Remission and active disease in rheumatoid arthritis: Defining criteria for disease activity states, 10.1002/art.21235
  22. Kavanaugh Arthur, Fleischmann Roy M, Emery Paul, Kupper Hartmut, Redden Laura, Guerette Benoit, Santra Sourav, Smolen Josef S, 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, 10.1136/annrheumdis-2011-201247
  23. Emery Paul, Burmester Gerd R, Bykerk Vivian P, Combe Bernard G, Furst Daniel E, Barré Emilie, Karyekar Chetan S, Wong Dennis A, Huizinga Tom W J, Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period, 10.1136/annrheumdis-2014-206106
  24. Hambardzumyan Karen, Bolce Rebecca, Saevarsdottir Saedis, Cruickshank Scott E, Sasso Eric H, Chernoff David, Forslind Kristina, Petersson Ingemar F, Geborek Pierre, van Vollenhoven Ronald F, Pretreatment multi-biomarker disease activity score and radiographic progression in early RA: results from the SWEFOT trial, 10.1136/annrheumdis-2013-204986
  25. Smolen Josef S., Aletaha Daniel, Barton Anne, Burmester Gerd R., Emery Paul, Firestein Gary S., Kavanaugh Arthur, McInnes Iain B., Solomon Daniel H., Strand Vibeke, Yamamoto Kazuhiko, Rheumatoid arthritis, 10.1038/nrdp.2018.1
  26. Hetland M L, Ejbjerg B, Horslev-Petersen K, Jacobsen S, Vestergaard A, Jurik A G, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen L S, Tarp U, Skjodt H, Pedersen J K, Majgaard O, Svendsen A J, Ellingsen T, Lindegaard H, Christensen A F, Vallo J, Torfing T, Narvestad E, Thomsen H S, Ostergaard M, , MRI bone oedema is the strongest predictor of subsequent radiographic progression in early rheumatoid arthritis. Results from a 2-year randomised controlled trial (CIMESTRA), 10.1136/ard.2008.088245
  27. de Rooy D. P. C., van der Linden M. P. M., Knevel R., Huizinga T. W. J., van der Helm-van Mil A. H. M., Predicting arthritis outcomes--what can be learned from the Leiden Early Arthritis Clinic?, 10.1093/rheumatology/keq230
  28. McWilliams Daniel F., Marshall Michelle, Jayakumar Keeranur, Doherty Sally, Doherty Michael, Zhang Weiya, Kiely Patrick D. W., Young Adam, Walsh David A., Erosive and osteoarthritic structural progression in early rheumatoid arthritis, 10.1093/rheumatology/kew197
  29. Möller Burkhard, Everts-Graber Judith, Florentinus Stefan, Li Yihan, Kupper Hartmut, Finckh Axel, Low Hemoglobin and Radiographic Damage Progression in Early Rheumatoid Arthritis: Secondary Analysis From a Phase III Trial, 10.1002/acr.23427
  30. Stojanovic Sonja, Bojana Stamenkovic, Stoimenov Tatjana Jevtovic, Nedovic Jovan, Zivkovic Valentina, Despotovic Milena, Pavlovic Dusica, Association of tumor necrosis factor–α (G-308A) genetic variant with matrix metalloproteinase–9 activity and joint destruction in early rheumatoid arthritis, 10.1007/s10067-017-3699-1
  31. Ziegelasch Michael, Forslind Kristina, Skogh Thomas, Riklund Katrine, Kastbom Alf, Berglin Ewa, Decrease in bone mineral density during three months after diagnosis of early rheumatoid arthritis measured by digital X-ray radiogrammetry predicts radiographic joint damage after one year, 10.1186/s13075-017-1403-0
  32. Asikainen J, Nikiphorou E, Kaarela K, Lindqvist E, Häkkinen A, Kautiainen H, Hannonen P, Rannio T, Sokka T (2016) Is long-term radiographic joint damage different between men and women? Prospective longitudinal data analysis of four early RA cohorts with greater than 15 years follow-up. Clin Exp Rheumatol 34:641–645
  33. Quintana-Duque Mario Andrés, Rondon-Herrera Federico, Calvo-Paramo Enrique, Yunis Juan Jose, Varela-Nariño Adriana, Iglesias-Gamarra Antonio, The impact of smoking on disease activity, disability, and radiographic damage in rheumatoid arthritis: is cigarette protective?, 10.1007/s00296-017-3845-8
Bibliographic reference van der Heijde, Désirée ; Durez, Patrick ; Schett, Georg ; Naredo, Esperanza ; Østergaard, Mikkel ; et. al. Structural damage progression in patients with early rheumatoid arthritis treated with methotrexate, baricitinib, or baricitinib plus methotrexate based on clinical response in the phase 3 RA-BEGIN study.. In: Clinical Rheumatology, Vol. 37, no.9, p. 2381-2390 (2018)
Permanent URL http://hdl.handle.net/2078.1/220481