Remission in patients with active rheumatoid arthritis by tocilizumab treatment in routine clinical practice: results from 3 years of prospectively registered data

Nakashima, Yasuharu; Kondo, Masakazu; Fukuda, Takaaki; Harada, Hiroshi; Horiuchi, Takahiko; Ishinishi, Takashi; Jôjima, Hiroshi; Kuroda, Koji; Miyahara, Hisaaki; Maekawa, Masayuki; Nishizaka, Hiroaki; Nagamine, Ryuji; Nakashima, Hitoshi; Otsuka, Takeshi; Shono, Eisuke; Suematsu, Eiichi; Shimauchi, Takashi; Tsuru, Tomomi; Wada, Ken; Yoshizawa, Shigeru; Yoshizawa, Seiji; Iwamoto, Yukihide

doi:10.3109/14397595.2013.854069

Cited by 22 publications

(7 citation statements)

References 25 publications

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“…We have found an impressive frequency of 57.9% DAS28 remission at 6 months. These rates are higher than those observed in published RCTs (27% OPTION [ 27 ], 30.1% RADIATE [ 28 ], 39.9% ADACTA [ 15 ], and 40.4% ACT-RAY [ 13 ]) but similar to other observational register-based studies (39–58% DANBIO [ 20 ], 53.3% Michinoku Tocilizumab Study Group [ 29 ], 47.8% CABUKI [ 23 ], and 54.9% FRAB [ 21 ]). The EULAR response rates, based on DAS28, were also similar to those found in RCTs [ 13 , 15 , 27 ] and observational studies [ 20 , 26 ] that reported them.…”

Section: Discussionsupporting

confidence: 76%

Comparative Effectiveness of Tocilizumab and TNF Inhibitors in Rheumatoid Arthritis Patients: Data from the Rheumatic Diseases Portuguese Register, Reuma.pt

Romão

Santos

Polido-Pereira

et al. 2015

BioMed Research International

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Objectives. To compare the effectiveness of TNF inhibitors (TNFi) and tocilizumab in rheumatoid arthritis (RA) treatment, according to different response criteria. Methods. We included RA patients registered in the Rheumatic Diseases Portuguese Register treated with TNFi or tocilizumab for at least 6 months, between January 2008 and July 2013. We assessed remission/low disease activity (LDA) at 6 months according to DAS28, CDAI, and SDAI, as well as Boolean ACR/EULAR remission and EULAR response rate, adjusting for measured confounders. Results. Tocilizumab-treated patients (n = 95) presented higher baseline disease activity and were less frequently naïve to biologics compared to TNFi users (n = 429). Multivariate logistic regression analysis including the propensity score for receiving tocilizumab showed that patients treated with tocilizumab were more likely to achieve remission or LDA according to DAS28 (OR = 11.0/6.2, 95% CI 5.6–21.6/3.2–12.0), CDAI (OR = 2.8/2.6, 95% CI 1.2–6.5/1.3–5.5), or SDAI (OR = 3.6/2.5, 95% CI 1.5–8.7/1.1–5.5), as well as a good EULAR response (OR = 6.4, 95% CI 3.4–12.0). However, both groups did not differ in Boolean remission (OR = 1.9, 95% CI 0.8–4.8) or good/moderate EULAR response (OR = 1.8, 95% CI 0.8–4.5). Conclusions. Compared with TNFi, tocilizumab was associated with greater likelihood of achieving DAS28, CDAI, and SDAI remission/LDA and EULAR good response. Boolean remission and EULAR good/moderate response did not differ significantly between groups.

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Section: Discussionsupporting

confidence: 76%

Comparative Effectiveness of Tocilizumab and TNF Inhibitors in Rheumatoid Arthritis Patients: Data from the Rheumatic Diseases Portuguese Register, Reuma.pt

Romão

Santos

Polido-Pereira

et al. 2015

BioMed Research International

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“…Overall, no TB cases were observed, though the 24-week duration of most studies may have led to underestimate the occurrence of active TB. However, also in the long-term trial, active TB cases did not occur [102, 109–114]. Equally, no TB cases were recorded in the only one registry of 302 RA patients treated with TCZ [115].…”

Section: Resultsmentioning

confidence: 99%

Risk of Tuberculosis Reactivation in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis Receiving Non-Anti-TNF-Targeted Biologics

Cantini

Nannini

Niccoli

et al. 2017

Mediators of Inflammation

113

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Tuberculosis (TB) still represents an important issue for public health in underdeveloped countries, but the use of antitumor necrosis factor agents (anti-TNF) for the treatment of inflammatory rheumatic disorders has reopened the problem also in countries with low TB incidence, due to the increased risk of TB reactivation in subjects with latent tuberculosis infection (LTBI). Over the last 5 years, several non-anti-TNF-targeted biologics have been licensed for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. We reviewed the epidemiology of TB, the role of different cytokines and of the immune system cells involved in the immune response against TB infection, the methods to detect LTBI, and the risk of TB reactivation in patients exposed to non-anti-TNF-targeted biologics. Given the limited role exerted by the cytokines different from TNF, as expected, data from controlled trials, national registries of biologics, and postmarketing surveillance show that the risk of TB reactivation in patients receiving non-anti-TNF-targeted biologics is negligible, hence raising the question whether the screening procedures for LTBI would be necessary.

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“…A large retrospective cohort study reported that the retention rates for TCZ switched from ABT and for ABT switched from biologics other than TCZ were not significantly different 22) . Although the efficacy of TCZ as a subsequent biologic may be lower than that observed in treatment-naïve patients 16,22,23) , TCZ may be effective in patients who have received two or more biologics.…”

Section: Discussionmentioning

confidence: 93%

“…A previous randomized prospective study reported that the clinical response at week 12 could predict low disease activity at 52 weeks in patients treated with certolizumab pegol 24) . Another prospec- tive study reported that RA patients who exhibited a good response at 1 month after starting TCZ were 5.5 times as likely to achieve remission at 36 months 23) . These reports support the theory that early treatment response can predict the achievement of low disease activity in RA patients.…”

Section: Discussionmentioning

confidence: 99%

Early Response of DAS28-ESR (3) Predicts Sustained Response to Tocilizumab Switched from Abatacept

Ando

Suzuki

Gotou

et al. 2019

J St. Marianna Univ

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Objective To determine the predictors of the therapeutic effects of tocilizumab (TCZ) switched from other biologics with different mechanisms of action in rheumatoid arthritis (RA).Methods Patients who switched from tumor necrosis factor inhibitors (TNFis) or abatacept (ABT) to TCZ were analyzed. They were categorized into two groups based on clinical disease activity at week 24 (response group: 28-joint disease activity score with erythrocyte sedimentation rate (DAS28-ESR) (3) ≤ 3.2, and non-response group: DAS28-ESR (3) > 3.2). We compared DAS28-ESR (3) at the initiation of TCZ therapy (ΔDAS) in patients switching from TNFis and ABT. We examined whether the therapeutic effect of TCZ switched from TNFis and ABT could be predicted using clinical parameters.Results Sixty-seven patients were analyzed (TNFis, 53; ABT, 14); of these, 36 (67.9%) patients who received TNFis and 6 (42.9%) who were treated with ABT were considered responders. In patients who switched from TNFis, ΔDAS in the non-response group was significantly lower than that in the response group until week 8, and the improvement in the non-response group reached a plateau at week 12. Conversely, in patients treated with ABT, ΔDAS was significantly different between the response and non-response groups in the early phase, i.e., at week 4. In univariate regression analysis, ΔDAS at week 4 was correlated with DAS28-ESR (3) at week 24 (p < 0.05) in patients switching from ABT. Receiver operating characteristic analyses suggested that 0.74 was the optimal ΔDAS cutoff at week 4 to predict response vs. non-response at week 24 (sensitivity: 100%, specificity: 87.5%, p < 0.001).Conclusion The efficacy of TCZ may vary depending on which biologics were used previously. The effectiveness of TCZ switched from ABT could be predicted by the therapeutic response at week 4.

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Remission in patients with active rheumatoid arthritis by tocilizumab treatment in routine clinical practice: results from 3 years of prospectively registered data

Abstract: In patients with RA, TCZ is highly effective for both biologics-naïve patients and patients previously exposed to biologics, achieving a high remission rate and drug continuation rate (68.2 %) in clinical practice.

Cited by 22 publications

References 25 publications

Comparative Effectiveness of Tocilizumab and TNF Inhibitors in Rheumatoid Arthritis Patients: Data from the Rheumatic Diseases Portuguese Register, Reuma.pt

Comparative Effectiveness of Tocilizumab and TNF Inhibitors in Rheumatoid Arthritis Patients: Data from the Rheumatic Diseases Portuguese Register, Reuma.pt

Risk of Tuberculosis Reactivation in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis Receiving Non-Anti-TNF-Targeted Biologics

Early Response of DAS28-ESR (3) Predicts Sustained Response to Tocilizumab Switched from Abatacept

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