Date: Sunday, November 8, 2015
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
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.
1) Nishimoto N, et al. Ann Rheum Dis. 2009; 68: 1580-4.
2) Nishimoto N, et al. Mod Rheumatol 2014; 24: 17-25.
To cite this abstract in AMA style:Kikuchi J, Shibata A, Sakai R, Chino K, Kondo T, Okuyama A, Takei H, Amano K. Prospective Study about Extension of Dosing Interval with Tocilizumab Therapy in Rheumatoid Arthritis Patients in Remission Maintenance [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/prospective-study-about-extension-of-dosing-interval-with-tocilizumab-therapy-in-rheumatoid-arthritis-patients-in-remission-maintenance/. Accessed January 23, 2022.
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