トシリズマブ単剤またはメトトレキサート併用で治療された関節リウマ チ患者において、寛解達成後のトシリズマブ休薬: 前向き無作為化試験結果 (SURPRISE試験2年目)

The second-year results from the SURPRISE study show that low disease activity (LDA) can be maintained after discontinuation of tocilizumab with continued methotrexate after remission is achieved. Discontinuation of biologic agents in patients who have achieved remission or low disease activity (LDA) is desirable from a risk–benefit point of view. Compared with TNF inhibitors, little is known regarding TCZ-free remission or LDA, but studies indicate that only a small proportion of patients remain in remission after discontinuing TCZ with or without concomitant csDMARDs such as MTX.1–3 SURPRISE was a 2-year, open-label, clinical study in patients with active RA despite MTX. In the first year, the investigators assessed the efficacy and safety of adding TCZ to MTX (ADD-ON) or switching from MTX to TCZ (SWITCH). Here, we report the results of the second year of SURPRISE in which patients achieving LDA at the end of year one were withdrawn from TCZ. The study suggests that discontinuation of TCZ after achievement of remission is feasible for many patients, although a higher percentage of those individuals in the ADD-ON group versus the SWITCH group maintained LDA (55% versus 27%). Rates of radiological non-progression or rapid progression did not differ between the groups however, more patients who continued MTX had adverse events, most commonly gastrointestinal disorders, than patients without csDMARDs. Importantly, among those who flared after TCZ discontinuation, the reinstitution of TCZ achieved remission in >90% of patients with or without MTX and was as efficacious as initial administration. The authors concluded that LDA can be maintained after discontinuation of TCZ with continued MTX in more than half of patients, and that resuming TCZ in those who subsequently lose disease control, is effective in in re-capturing those individuals to achieve remission once again. 1. Nishimoto N, et al. Mod Rheumatol 2014;24:17–25. 2. Huizinga TW, et al. Ann Rheum Dis 2015;74:35–43. 3. Aguilar-Lozano L, et al. J Rheumatol 2013;40:1069–73.