Initiating tocilizumab, with or without methotrexate, compared with starting methotrexate with prednisone within step-up treatment strategies in early rheumatoid arthritis: an indirect comparison of effectiveness and safety of the U-Act-Early and CAMERA-II treat-to-target trials.

Autor:	Verhoeven MM; Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands m.m.a.verhoeven-15@umcutrecht.nl., de Hair MJ; Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands., Tekstra J; Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands., Bijlsma JW; Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands., van Laar JM; Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands., Pethoe-Schramm A; ACTEMRA/Rheumatology, F Hoffmann-La Roche AG, Basel, Switzerland., Borm ME; Rheumatology, Roche Nederland BV, Woerden, The Netherlands., Ter Borg EJ; Department of Rheumatology, Sint Antonius Ziekenhuis, Nieuwegein, The Netherlands., Linn-Rasker SP; Department of Rheumatology, Meander Medical Centre, Amersfoort, The Netherlands., Teitsma XM; Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands., Lafeber FP; Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands., Jacobs JW; Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands., Welsing PM; Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands.
Jazyk:	angličtina
Zdroj:	Annals of the rheumatic diseases [Ann Rheum Dis] 2019 Oct; Vol. 78 (10), pp. 1333-1338. Date of Electronic Publication: 2019 Jun 13.
DOI:	10.1136/annrheumdis-2019-215304
Abstrakt:	Objectives: Methotrexate (MTX), often combined with low moderately dosed prednisone, is still the cornerstone of initial treatment for early rheumatoid arthritis (RA). It is not known how this strategy compares with initial treatment with a biological. We therefore compared the effectiveness of tocilizumab (TCZ), or TCZ plus MTX (TCZ+MTX) with MTX plus 10 mg prednisone (MTX+pred), all initiated within a treat-to-target treatment strategy in early RA. Methods: Using individual patient data of two trials, we indirectly compared tight-controlled treat-to-target strategies initiating TCZ (n=103), TCZ+MTX (n=106) or MTX+pred (n=117), using initiation of MTX (n=227) as reference. Primary outcome was Disease Activity Score assessing 28 joints (DAS28) over 24 months. To assess the influence of acute phase reactants (APRs), a disease activity composite outcome score without APR (ie, modification of the Clinical Disease Activity Index (m-CDAI)) was analysed. Secondary outcomes were remission (several definitions), physical function and radiographic progression. Multilevel models were used to account for clustering within trials and patients over time, correcting for relevant confounders. Results: DAS28 over 24 months was lower for TCZ+MTX than for MTX+Pred (mean difference: -0.62 (95% CI -1.14 to -0.10)). Remission was more often achieved in TCZ+MTX and in TCZ versus MTX+pred (p=0.02/0.05, respectively). Excluding APRs from the disease activity outcome score, TCZ-based strategies showed a slightly higher m-CDAI compared with MTX+pred, but this was not statistically significant. Other outcomes were also not statistically significantly different between the strategies. Conclusions: In patients with early RA, although TCZ-based strategies resulted in better DAS28 and remission rates compared with MTX+pred, at least part of these effects may be due to a specific effect of TCZ on APRs. Competing Interests: Competing interests: JWJB reports grants and fees from Roche, AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer and UCB. JMvL reports grants from Arthrogen, grants from MSD, personal fees from Pfizer, personal fees from Eli Lilly, personal fees from BMS, grants from Astra Zeneca and grants from Roche-Genentech. AP-S is an employee of F Hoffmann-La Roche. MEAB is an employee of Roche Netherlands BV. FPJL reports grants from Roche. (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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