Objective: To determine the effect of changing from etanercept or methotrexate monotherapy to etanercept plus methotrexate combination therapy on radiographic progression in rheumatoid arthritis (RA) patients.
Methods: Patients enrolled in this 1-year open-label study previously completed a 3-year blinded study in which they received methotrexate or etanercept monotherapy or the combination of both. All patients received the combination of etanercept 25 mg subcutaneously twice weekly plus oral methotrexate up to 20 mg/week. The primary radiographic endpoint was a change in modified total Sharp score (TSS), as assessed by blinded readers.
Results: At baseline, patients previously receiving methotrexate monotherapy (etanercept-added, n = 52) or etanercept monotherapy (methotrexate-added, n = 68) had moderate disease activity levels (mean disease activity score (DAS) of 2.6 and 2.5, respectively), whereas patients previously receiving combination therapy (n = 90) had a low disease activity level (mean DAS of 2.0). The addition of etanercept to methotrexate monotherapy resulted in a significant reduction in radiographic progression (p<0.05). Mean TSS changes in the previous year versus the current year were +1.79 versus +0.25 for the etanercept-added group (p<0.05); +0.51 versus −0.18 for the methotrexate-added group (NS) and +0.42 versus +0.24 for the combination group (NS).
Conclusion: In these RA patients with on average moderate disease activity despite previous methotrexate monotherapy, combination treatment with etanercept and methotrexate inhibited radiographic progression and improved radiographic outcomes. These data, in conjunction with the previously published clinical data, support the use of combination therapy in RA patients with moderate disease activity.
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Funding: This study was supported by Wyeth Pharmaceuticals, Collegeville, Pennsylvania, USA.
Competing interests: DvdH has received consulting fees, research grants, and/or speaking fees from Abbott, Amgen, Aventis, Bristol Myers Squibb, Centocor, Pfizer, Roche, Schering Plough, UCB and Wyeth; GB has received honoraria and fees for lectures, consulting and research grants from Wyeth; JM-G participated as an investigator for this Wyeth-funded study; CC received funding for research and speaker fees from Wyeth; EMM has received fees as a consultant and for organising educational programmes for Abbott, Centocor, Schering-Plough and Bristol Myers Squibb; DC was employed by Wyeth Pharmaceuticals at the time of study conduct; RP, DR, AK and BF are employed by and have stock options with Wyeth Pharmaceuticals.
Ethics approval: The study protocol and an informed consent form received approval by the independent ethics committee or institutional review board at each institution before study initiation. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki.
Patient consent: Obtained.
Etanercept study 400 investigators: HD Bolosiu, Cluj-Napoca, Romania; J Brzezicki, Elblag, Poland; G-R Burmester, Berlin, Germany; B Canesi, Milano, Italy; H Chwalinska-Sadowska, Warszawa, Poland; C Codreanu, Bucuresti, Romania; M Cutolo, Genova, Italy; J de Melo Gomes, Lisboa, Portugal; A Filipowicz-Sosnowska, Warszawa, Poland; S Freiseleben-Sorensen, Copenhagen, Denmark; P Geusens, Diepenbeek, Belgium; JJ Gómez Reino, Santiago de Compostela, Spain; N Graudal, Herlev, Denmark; G Herrero-Beaumont, Madrid, Spain; M Janssen, Arnhem, The Netherlands; H Julkunen, Vantaa, Finland; J Kalden, Erlangen, Germany; J Kekow, Vogelsang, Germany; A Laffón, Madrid, Spain; H Lang, Plauen, Germany; P Lanting, Doetinchem, The Netherlands; R Luosujarvi, Kuopio, Finland; R Luukkainen, Satalinna, Finland; M Malaise, Liege, Belgium; E Martín Mola, Madrid, Spain; Z Mencel, Kalisz, Poland; C Montecucco, Pavia, Italy; K Pavelka, Prague, Czech Republic; A Perniok, Köln, Germany; F Radulescu, Bucuresti, Romania; R Sanmartí, Barcelona, Spain; L Settas, Thessaloniki, Greece; H Stehlikova, Ceska Lipa, Czech Republic; J Szechinski, Wroclaw, Poland; J Szerla, Krakow, Poland; C Tanasescu, Bucuresti, Romania; J Tornero, Guadalajara, Spain; S Transo, Jonkoping, Sweden; T Tuomiranta, Tampere, Finland; S Valtysdottir, Uppsala, Sweden; E Veys, Gent, Belgium; H Van den Brink, Alkmaar, The Netherlands; M Van de Laar, Enschede, The Netherlands; P Vitek, Zlin, Czech Republic; R Zahora, Terezin, Czech Republic.
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