Premium
Sustained Response Following Discontinuation of Methotrexate in Patients With Rheumatoid Arthritis Treated With Subcutaneous Tocilizumab
Author(s) -
Kremer Joel M.,
Rigby William,
Singer Nora G.,
Birchwood Christine,
Gill Darcy,
Reiss William,
Pei Jinglan,
Michalska Margaret
Publication year - 2018
Publication title -
arthritis and rheumatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.106
H-Index - 314
eISSN - 2326-5205
pISSN - 2326-5191
DOI - 10.1002/art.40493
Subject(s) - medicine , tocilizumab , rheumatoid arthritis , discontinuation , methotrexate , erythrocyte sedimentation rate , confidence interval , randomized controlled trial , gastroenterology , adverse effect , combination therapy , surgery
Objective To evaluate whether tocilizumab ( TCZ ) monotherapy is noninferior to treatment with TCZ plus methotrexate ( MTX ) for maintaining clinical responses in patients with rheumatoid arthritis ( RA ) in whom low disease activity is achieved with TCZ plus MTX . Methods Patients with RA who experienced an inadequate response to MTX received MTX plus TCZ 162 mg subcutaneously. At 24 weeks, patients who achieved a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate ( DAS 28‐ ESR ) of ≤3.2 were randomized to receive TCZ monotherapy or to continue treatment with TCZ plus MTX until week 52. The primary outcome measure was the comparison of the mean change in the DAS 28‐ ESR from week 24 to week 40 between the TCZ monotherapy and TCZ plus MTX arms (noninferiority margin of 0.6). Secondary outcome measures included worsening of the DAS 28‐ ESR by ≥1.2, achievement of a DAS 28‐ ESR of <2.6 and ≤3.2, and safety and immunogenicity. Results Among the 718 patients enrolled, 296 were randomized at week 24 to receive TCZ monotherapy (n = 147) or TCZ plus MTX (n = 147). The mean changes in the DAS 28‐ ESR from week 24 to week 40 were 0.46 and 0.14 in the TCZ monotherapy arm and the TCZ plus MTX arm, respectively (weighted difference between the groups, 0.318 [95% confidence interval 0.045, 0.592]); discontinuing MTX in TCZ responders was noninferior to continuing MTX . Safety events were broadly similar between the randomized treatment groups; the most common serious adverse event was infection, which occurred in 2.1% of patients in the TCZ monotherapy group and 2.2% of patients receiving TCZ plus MTX . Conclusion Patients with RA receiving TCZ plus MTX who achieve low disease activity can discontinue MTX without significant worsening of disease activity during the 16 weeks following MTX discontinuation.