Efficacy and tolerability of six-week extended dosing interval with tocilizumab therapy in a prospective cohort as remission maintenance in patients with rheumatoid arthritis

Kikuchi, Jun; Kondo, Tsuneo; Shibata, Akiko; Sakai, Ryota; Okada, Yusuke; Chino, Kentaro; Okuyama, Atsushi; Kurasawa, Takahiko; Takei, Hiroyuki; Amano, Koichi

doi:10.1080/14397595.2017.1366092

Cited by 8 publications

(13 citation statements)

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“…By contrast, sustained remission following cessation of TCZ treatment was much lower: in the DREAM study (13), drug free remission or LDA was present in 35.1%, and 13.4% of patients after 24 and 52 weeks respectively following cessation of TCZ used in monotherapy, and in the ACT-RAY study, the remission rate dropped to 16% after stopping TCZ (28). In our study, we observed that a majority (61.5%) of our patients remained in remission at month 24 and 46.1% had successful long-term maintenance following the tapering of TCZ infusions, results that are comparable to those of previous studies (14,25,26).…”

Section: Characteristics Of Patientssupporting

confidence: 90%

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Successful long-term remission through tapering tocilizumab infusions: a single-center prospective study

Ladhari

Blay

Vincent³

et al. 2019

Preprint

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Background: Strategic drug therapy for rheumatoid arthritis (RA) patients with prolonged remission is not well defined. According to recent guidelines, tapering biological Disease-Modifying Anti-Rheumatic Drugs (bDMARDs) may be considered. We aimed to evaluate the effectiveness of long-term maintenance of tocilizumab (TCZ) treatment after the progressive tapering of infusions. Methods: We conducted an exploratory, prospective, single-center, open-label study, on RA patients with sustained remission of at least 3 months and treated with TCZ infusions every 4 weeks. The initial re-treatment interval was extended to 6 weeks for the first 3 months. Thereafter, the spacing between infusions was determined by the clinician. Successful long-term maintenance following the tapering of TCZ infusions was defined by patients still treated after two years by TCZ with a minimum dosing interval of 5 weeks.Results: Thirteen patients were enrolled in the study. Eight out of thirteen were still treated by TCZ after two years. Successful long-term maintenance was possible in six patients, with four patients maintaining a re-treatment interval of 8-weeks or more. We observed 5 patients with TCZ withdrawal: one showing adverse drug reaction (neutropenia) and four with secondary failure. Patients achieving successful long-term maintenance with TCZ were significantly younger than those with secondary failure (p<0.05). In addition, RA patients with positive rheumatoid factor and anti-citrullinated peptide antibodies, experienced a significantly greater number of flares during our 2-year follow-up (p<0.01).Conclusions: A progressive tapering of TCZ infusions may be possible for many patients. However, larger studies, including more patients, are needed to confirm this therapeutic option.

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Section: Characteristics Of Patientssupporting

confidence: 90%

“…weeks for RA patients in sustained remission for the previous 3 months appeared to provide an acceptable option, with 88% retaining remission after 54 weeks (14). Similarly, Saiki et al published two studies on extending the RTI for TCZ infusions.…”

Section: Characteristics Of Patientsmentioning

confidence: 98%

Successful long-term remission through tapering tocilizumab infusions: a single-center prospective study

Ladhari

Blay

Vincent³

et al. 2019

Preprint

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“…Concerning TCZ tapering, several strategies have been tried, including discontinuation TCZ infusions [12,13], and gradually increasing the RTI to a fixed interval (eg. 6-weeks) [14,[25][26][27]. We conducted the present study to determine if tapering TCZ by progressively increasing the spacing of infusions would be a better strategy to maintain TCZ-treated patients in remission.…”

Section: Discussionmentioning

confidence: 99%

“…Recent studies suggest that TCZ could induce drug-free remission in a low proportion of patients [12,13]. However, few data reporting the efficacy and safety of TCZ tapering are available and the follow-up of patients is short (less than one year) [14]. We hypothesized that increasing the interval or spacing between TCZ infusions, rather than abruptly stopping treatment in RA patients with remission, may represent a better strategy to reduce the risk of flare.…”

Section: Introductionmentioning

confidence: 99%

Successful long-term remission through tapering tocilizumab infusions: a single-center prospective study

Ladhari

Blay

Vincent³

et al. 2020

BMC Rheumatol

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Background: Strategic drug therapy for rheumatoid arthritis (RA) patients with prolonged remission is not well defined. According to recent guidelines, tapering biological Disease-Modifying Anti-Rheumatic Drugs (bDMARDs) may be considered. We aimed to evaluate the effectiveness of long-term maintenance of tocilizumab (TCZ) treatment after the progressive tapering of infusions. Methods: We conducted an exploratory, prospective, single-center, open-label study, on RA patients with sustained remission of at least 3 months and treated with TCZ infusions every 4 weeks. The initial re-treatment interval was extended to 6 weeks for the first 3 months. Thereafter, the spacing between infusions was determined by the clinician. Successful long-term maintenance following the tapering of TCZ infusions was defined by patients still treated after two years by TCZ with a minimum dosing interval of 5 weeks. Results: Thirteen patients were enrolled in the study. Eight out of thirteen were still treated by TCZ after two years. Successful long-term maintenance was possible in six patients, with four patients maintaining a re-treatment interval of 8-weeks or more. We observed 5 patients with TCZ withdrawal: one showing adverse drug reaction (neutropenia) and four with secondary failure. Patients achieving successful long-term maintenance with TCZ were significantly younger than those with secondary failure (p < 0.05). In addition, RA patients with positive rheumatoid factor and anti-citrullinated peptide antibodies, experienced a significantly greater number of flares during our 2year follow-up (p < 0.01). Conclusions: A progressive tapering of TCZ infusions may be possible for many patients. However, larger studies, including more patients, are needed to confirm this therapeutic option.

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“…Иная ситуация складывается в случае достижения неактивного статуса болезни. Исследования при РА у взрослых пациентов, достигших ремиссии, продемонстрировали возможность увеличения интервала между инфузиями ТЦЗ до 6 нед [19]. В исследовании E.A.…”

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Optimization of systemic juvenile arthritis treatment regimens with correction of tocilizumab intravenous administration according to data of observational retrospective study

Каледа¹,

Nikishina²,

Костарева³

2019

Naučno-praktičeskaâ revmatologiâ

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Objective: to assess the possibility of using varying interval between intravenous infusions of tocilizumab (TCZ) as a tool for choosing the optimal treatment regimen in systemic juvenile arthritis (SJA).Subjects and methods. The observational retrospective study included 72 patients (29 boys and 43 girls) with a SJA fulfilled ILAR criteria, who received TCZ ≥12 months, in which previous therapy with various anti-rheumatic drugs was ineffective. We studied the changes of the main clinical and laboratory parameters of the SJA activity after correction of the interval between infusions.Results and discussion. In the studied group median age of onset was 3.8 [2.1; 5.9] years, duration of disease before the appointment of TCZ – 26.5 [9.25; 62.25] months. Therapy is continued by 70 patients, the median duration of therapy is 5.0 [2.75; 6.38] years. The initial interval between TCZ infusions was 2 weeks in 49 (group 1) and 4 weeks in 23 patients (group 2). After 6 months of therapy in group 2, the interval was reduced to 2 weeks in 15 (65.2%) patients due to decreased effectiveness. Prolongation of the period between the introduction of TCZ in patients of group 1 who did not reach the inactive status of the disease in the 1st year of the disease resulted in a significant increase of erythrocyte sedimentation rate, C-reactive protein level and exacerbation of systemic manifestations of SJA (p<0.01) in the absence of statistically significant changes of joint status parameters (p>0.05). 40% of these patients had involvement of «new» joints, including hip joints. «Harbingers» of exacerbation in the period of increasing intervals between infusions were: arthralgia (88%), myalgia (65%), sore throat (30%), dysphoria (50%, more often in preschool children), increase of ferritin level and number of leukocytes. In 90.3% of patients who have reached the inactive status of the disease, it was possible to gradually increase the interval between infusions. In 6 patients, TCZ was canceled by gradually increasing the intervals, in 4 of them, therapy was resumed at an initial interval of 2 weeks after 3, 6, 21 and 22 months, respectively, in two patients, a drug-free remission was maintained during 23 and 20 months. Reduction of intervals to the initial 2 weeks was performed in 13 (18.1%) patients. The development of exacerbations with the need to reduce the interval to the initial one was most often observed at 24–35 months of therapy, which chronologically coincided with the period of active growth. Currently, 15 patients receiving TCZ with an interval of 5–6 weeks, and 40 – with an interval of 4 weeks, 9 patients – 3 weeks, in 6 patients attempt to increase the interval to more than 2–2,5 weeks was unsuccessful.Conclusion. Experience suggests the need to comply with a two-week interval between infusions of TCZ at the initial stage of therapy in most patients with SJA until the inactive stage of the disease, followed by a smooth individual increase in the interval to 4 weeks (2–3 days under careful medical supervision). Appearance of initial signs of exacerbation, requires to reduce the interval to 2 weeks. Before deciding on the complete withdrawal of TCZ, it is advisable to increase the interval between infusions to 5–6 weeks under careful clinical and laboratory control.

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Efficacy and tolerability of six-week extended dosing interval with tocilizumab therapy in a prospective cohort as remission maintenance in patients with rheumatoid arthritis

Abstract: A six-week extended dosing interval of TCZ for patients with RA in sustained remission is proposed as an acceptable treatment option for maintaining efficacy and tolerability.

Cited by 8 publications

References 20 publications

Successful long-term remission through tapering tocilizumab infusions: a single-center prospective study

Successful long-term remission through tapering tocilizumab infusions: a single-center prospective study

Successful long-term remission through tapering tocilizumab infusions: a single-center prospective study

Optimization of systemic juvenile arthritis treatment regimens with correction of tocilizumab intravenous administration according to data of observational retrospective study

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