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Sustained Response Following Discontinuation of Methotrexate in Patients With Rheumatoid Arthritis Treated With Subcutaneous Tocilizumab: Results From a Randomized, Controlled Trial

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Kremer JM1, Rigby W2, Singer NG3, Birchwood C4, Gill D4, Reiss W4, Pei J4, Michalska M4. Arthritis Rheumatol. 2018 Mar 25. doi: 10.1002/art.40493. [Epub ahead of print]


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1 Albany Medical College and The Center for Rheumatology, Albany, NY.

2 Geisel School of Medicine, Dartmouth College, Lebanon, NH.

3 Case Western Reserve University School of Medicine, MetroHealth System, Cleveland, OH.

4 Genentech, Inc, South San Francisco, CA.


OBJECTIVE: To evaluate whether tocilizumab (TCZ) monotherapy is non-inferior to TCZ + methotrexate (MTX) in maintaining clinical response in patients with rheumatoid arthritis (RA) who achieve low disease activity with TCZ+MTX.

METHODS: Patients with RA who experienced an inadequate response to MTX received MTX plus TCZ 162 mg subcutaneous. At 24 weeks, patients who achieved Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) ≤3.2 were randomized to receive TCZ monotherapy or continue TCZ+MTX until week 52. The primary outcome was the comparison of mean change in DAS28-ESR from weeks 24 to 40 between the TCZ monotherapy and TCZ+MTX arms (non-inferiority margin of 0.6). Secondary outcomes included DAS28-ESR worsening ≥1.2, achievement of DAS28-ESR <2.6 and ≤3.2 and safety and immunogenicity.

RESULTS: Of 718 patients enrolled, 294 were randomized at week 24 (TCZ monotherapy, n = 147; TCZ+MTX, n = 147). The mean changes in DAS28-ESR from weeks 24 to 40 were 0.46 and 0.14 in the TCZ monotherapy and TCZ+MTX arms, respectively (weighted difference between the groups, 0.318 [95% CI 0.045, 0.592]); discontinuing MTX in TCZ responders was non-inferior to continuing MTX. Safety events were broadly similar between the randomized treatment groups; the most common serious adverse event was infection, occurring in 2.1% of patients in the TCZ monotherapy group and 2.2% in the TCZ+MTX group.

CONCLUSION: Patients with RA receiving TCZ+MTX who achieve low disease activity can discontinue MTX without significant worsening of disease activity in the 16 weeks following MTX discontinuation.