Patients with rheumatoid arthritis (RA) who are treated with tocilizumab and methotrexate may safely discontinue methotrexate after achieving low disease activity without a significant worsening of disease activity, according to results published in Arthritis & Rheumatology.
The study included patients with RA who had a prior inadequate treatment response to methotrexate. Each participant received 162 mg subcutaneous tocilizumab plus methotrexate. Participants who achieved Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) ≤3.2 were randomly assigned to receive tocilizumab monotherapy or to continue tocilizumab plus methotrexate until week 52.
The primary outcome was the comparison of mean change in DAS28-ESR from weeks 24 to 40 between the groups (noninferiority margin, 0.6). Secondary outcomes included DAS28-ESR worsening ≥1.2, achievement of DAS28-ESR <2.6 and ≤3.2, and safety and immunogenicity.
Initially, 718 participants were enrolled in the study. At week 24, 294 of these participants were randomly assigned, with 147 in the tocilizumab monotherapy group and 147 in the tocilizumab plus methotrexate group.
Participants in the tocilizumab monotherapy group had a mean change in the DAS28-EST of 0.46 from weeks 24 to 40 compared with a mean change of 0.14 among the participants in the tocilizumab plus methotrexate group. Discontinuing methotrexate among participants who responded to tocilizumab was noninferior to continuing methotrexate.
Both treatment groups had similar safety events. The most common serious adverse event was infection, which occurred in 2.1% of participants in the tocilizumab monotherapy group and 2.2% of participants in the tocilizumab plus methotrexate group.
“The non-inferiority of [tocilizumab] monotherapy to [tocilizumab plus methotrexate] observed in this study suggests that patients with RA receiving [tocilizumab] who cannot tolerate or prefer not to use [methotrexate] can safely discontinue it without a significant worsening in disease activity,” the study authors concluded.
This study was sponsored by Genentech, Inc. Please refer to original study text for full list of disclosures.
Kremer JM, Rigby W, Singer NG, et al. Sustained response following discontinuation of methotrexate in patients with rheumatoid arthritis treated with subcutaneous tocilizumab: results from a randomized, controlled trial [published online March 25, 2018]. Arthritis Rheumatol. doi:10.1002/art.40493