Sustained Response Following Discontinuation of Methotrexate in Patients With Rheumatoid Arthritis Treated With Subcutaneous Tocilizumab

Kremer, Joel M.; Rigby, William F.C.; Singer, Nora G.; Birchwood, Christine; Gill, Darcy; Reiss, William; Pei, Jinglan; Michalska, Margaret

doi:10.1002/art.40493

Cited by 43 publications

(25 citation statements)

References 39 publications

(53 reference statements)

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“…For the mean change in DAS28 response from baseline of the core study to LTE week 108, the proportion of patients achieving clinical remission (DAS28 < 2.6) and the overall ACR response rates were similar across the TCZ monotherapy, TCZ + 1 csDMARD, and TCZ + > 1 csDMARD groups. Consistent with previous studies, effectiveness was similar between patients receiving TCZ monotherapy and those receiving TCZ in combination with csDMARDs [16,18,20,26] and was maintained over 132 weeks. Improvements in PRO scores were also similar to those in previous studies of TCZ and remained stable over time [10][11][12][31][32][33].…”

Section: Discussionsupporting

confidence: 88%

“…Tocilizumab (TCZ), a humanized monoclonal antibody that blocks the interleukin (IL)-6 receptor-alpha, has been shown to be a safe and effective treatment for patients with early or established RA in randomized controlled trials, either as monotherapy or in combination with csDMARDs [10][11][12][13][14][15][16][17][18][19][20]. The long-term effectiveness and safety of TCZ have been established in multiple clinical trials [21][22][23][24], thus informing patient care decisions in clinical practice because patients with RA often receive prolonged treatment.…”

Section: Introductionmentioning

confidence: 99%

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Long-term safety and effectiveness of tocilizumab in patients with rheumatoid arthritis and inadequate responses to csDMARDs and/or TNF inhibitors: an open-label study close to clinical practice

et al. 2019

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Objective To assess the long-term safety, tolerability, and effectiveness of tocilizumab (TCZ) as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in clinical practice in patients with moderate to severe rheumatoid arthritis (RA). Methods Patients in the 24-week, open-label ACT-SURE study who had at least a moderate EULAR response by week 24 and were from a participating country were eligible for this long-term extension (LTE); the patients continued to receive TCZ 8 mg/kg intravenously every 4 weeks as monotherapy or in combination with ≥ 1 csDMARD for up to an additional 108 weeks. The primary endpoint was the incidence of adverse events (AEs) and serious AEs (SAEs). Effectiveness endpoints included Disease Activity Score in 28 joints (DAS28) responses, American College of Rheumatology (ACR) responses, and patient-reported outcomes (PROs). Results Of the 1102 patients who completed the core 24-week study, 934 participated in the LTE; the median exposure to TCZ was 64.3 weeks. From baseline to the end of the LTE, AEs and SAEs occurred in 90% and 9% of patients, respectively. The overall event rates (95% CI) of AEs and SAEs were 406.5 per 100 patient-years (PY) (395.5, 417.8) and 8.8 per 100 PY (7.3, 10.6), respectively. Mean (SD) improvement in DAS28 was 4.12 (1.18), P < 0.0001. The DAS28 remission rates, ACR response rates, and PRO scores were maintained during the LTE study. Conclusion In clinical practice, TCZ as monotherapy or in combination with csDMARDs was safe, well tolerated, and efficacious in patients with moderate to severe RA.

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Section: Discussionsupporting

confidence: 88%

Section: Introductionmentioning

confidence: 99%

Long-term safety and effectiveness of tocilizumab in patients with rheumatoid arthritis and inadequate responses to csDMARDs and/or TNF inhibitors: an open-label study close to clinical practice

et al. 2019

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“…Cechuje go duży profil bezpieczeństwa i mały odsetek powikłań i działań niepożądanych. Więcej niż połowa badanych pacjentów otrzymuje tocilizumab w monoterapii co nie przekłada się na pogorszenie skuteczności leczenia, co jest to potwierdzeniem danych płynących z badań klinicznych [6,7,9].…”

Section: Działania Niepożądane Tocilizumabuunclassified

Doświadczenia własne w zastosowaniu tocilizumabu w leczeniu chorych na reumatoidalne zapalenie stawów

Dziewit

Kopeć-Mędrek

Kucharz

2019

Forum Reumatologiczne

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“…Thus far, a randomized controlled trial of MTX withdrawal in patients responding to TCZ plus MTX demonstrated that TCZ as monotherapy was clinically noninferior to continued use of TCZ plus MTX [17]. However, the frequency of such changes in therapy in the real world, and the extent to which TCZ can decrease the need for concomitant MTX use in routine clinical practice, remains unknown.…”

Section: Introductionmentioning

confidence: 99%

Methotrexate Discontinuation and Dose Decreases After Therapy With Tocilizumab: Results From the Corrona Rheumatoid Arthritis Registry

Pappas

Blachley²,

Zlotnick³

et al. 2020

Rheumatol Ther

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Introduction: Similar outcomes have been observed between patients with rheumatoid arthritis (RA) responding to tocilizumab (TCZ) with methotrexate (MTX) who discontinued vs. continued MTX and between patients receiving MTX who added TCZ vs. switched to TCZ monotherapy. This study examined MTX discontinuation and dose decreases in patients with RA initiating TCZ in a real-world setting. Methods: TCZ-naïve patients enrolled in the Corrona RA registry who initiated TCZ in combination with MTX and had a 6-month followup visit without TCZ discontinuation were included. Patients were grouped by MTX dose at the time of TCZ initiation (B 10 mg, [ 10 to B 15 mg, [ 15 to B 20 mg, [ 20 mg). The primary outcome was the proportion of patients with changes in MTX use at 6 months, with a secondary analysis at 12 months. Changes in disease activity [Clinical Disease Activity Index (CDAI)] and patient-reported outcomes (PROs) at 6 and 12 months were summarized descriptively. Results: Of 444 included patients, 82.7% were female and 83.7% white, with mean (SD) disease duration of 11.6 (9.3) years, baseline CDAI score of 24.0 (15.4), and baseline MTX dose of 17.7 (5.8) mg. At 6 months, 139 patients (31.3%) discontinued or decreased their MTX dose. All MTX dose groups and patients who discontinued, decreased, maintained, or increased their MTX dose displayed improvements in CDAI scores and PROs at 6 months. Similar patterns and results were observed at 12 months. Conclusions: A considerable proportion of patients initiating TCZ discontinued or decreased their MTX dose after TCZ initiation. Improvements in disease activity and functionality were observed in patients who decreased or stopped MTX. This real-world study confirmed prior observations that discontinuing or decreasing MTX may be a treatment strategy for patients initiating TCZ combination therapy. Trial Registration: ClinicalTrials.gov identifier, NCT01402661.

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Sustained Response Following Discontinuation of Methotrexate in Patients With Rheumatoid Arthritis Treated With Subcutaneous Tocilizumab

Abstract: Patients with RA receiving TCZ plus MTX who achieve low disease activity can discontinue MTX without significant worsening of disease activity during the 16 weeks following MTX discontinuation.

Cited by 43 publications

References 39 publications

Long-term safety and effectiveness of tocilizumab in patients with rheumatoid arthritis and inadequate responses to csDMARDs and/or TNF inhibitors: an open-label study close to clinical practice

Long-term safety and effectiveness of tocilizumab in patients with rheumatoid arthritis and inadequate responses to csDMARDs and/or TNF inhibitors: an open-label study close to clinical practice

Doświadczenia własne w zastosowaniu tocilizumabu w leczeniu chorych na reumatoidalne zapalenie stawów

Methotrexate Discontinuation and Dose Decreases After Therapy With Tocilizumab: Results From the Corrona Rheumatoid Arthritis Registry

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