Background/Purpose: Tocilizumab (TCZ) is clinically effective against rheumatoid arthritis (RA) and over 50% of RA patients who had completed 5 years of TCZ treatment maintained remission¹⁾. However, long-term treatment of biologics is often the cause of economic burden and restriction of treatment options. Although there are some trials to stopping biologics for patients in remission²⁾, efficacy and tolerability of extended dosing interval with TCZ is not known. Objective of this study is to evaluate the efficacy and tolerability of 6-week extended dosing interval with TCZ in RA patients in remission.

Methods: Eligible patients were those who met the 2010 ACR/EULAR classification criteria. Consecutive patients at our institute who had received over 6 times of TCZ injection in remission maintained over 3 months with their informed consent between December 2013 and December 2014. The cut-off value of remission was DAS28-ESR <2.6. Last observation carried forward method was used for consecutive analysis.

Results: Fifteen patients were enrolled. At baseline, mean age was 52.0 ± 13.9 year-old, and the percentage of female was 78.6%. Mean disease duration was 11.0 ± 10.8 years. 21.4% and 7.1% of patients used concomitant methotrexate and glucocorticoids, respectively. 35.7% of patients previously used biologics. Mean duration until beginning the extension of dosing interval from starting TCZ was 38.6 ± 22.1 months. Mean duration until achieving remission from starting TCZ was 1.96 ± 2.56 months. Mean DAS28-ESR was 0.98 ± 0.74 at baseline. 77.8% of patients were seropositive. Thirteen (86.7%) patients have completed TCZ with 6-week extended dosing interval until Week 24, and all of them maintained in remission, though DAS28-ESR mildly increased to 1.55 ± 0.21 at Week 24 (p=0.026, baseline vsWeek 24). CRP and ESR also tended to increase until Week 6 (p=0.071 and p=0.220, respectively), but did not change between Week 6 and Week 24 (p=0.842 and p=0.661, respectively). The change in DAS28-ESR at Week 24 did not correlate with the baseline parameters including age, sex, disease duration, CRP, ESR, MMP-3 and the seropositivity. The patients whose durations until achieving remission from starting TCZ were shorter tended to maintain lower disease activities (Spearman’s rho=0.49, p=0.072). One patient dropped from the study because of the RA flare and returned to 4-week interval at Week 18. Five adverse events were noted in 5 patients. TCZ was discontinued due to the recurrence of lymphoproliferative disorder in one patient at Week 12. The other 4 events (2 mild upper respiratory infections, the fracture of humerus by falling accident and ureterolithiasis) did not lead to cessation of TCZ.

Conclusion: This trial suggested that 6-week extended dosing interval with TCZ therapy is effective and tolerable in RA patients as remission maintenance in daily clinical practice.

Reference:

1) Nishimoto N, et al. Ann Rheum Dis. 2009; 68: 1580-4.

2) Nishimoto N, et al. Mod Rheumatol 2014; 24: 17-25.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/prospective-study-about-extension-of-dosing-interval-with-tocilizumab-therapy-in-rheumatoid-arthritis-patients-in-remission-maintenance/