Drug retention and discontinuation reasons between seven biologics in patients with rheumatoid arthritis -The ANSWER cohort study-

Ebina, Kosuke; Hashimoto, Motomu; Yamamoto, Wataru; Ohnishi, Akiko; Kabata, Daijiro; Hirano, Tôru; Hara, Ryota; Katayama, Masaki; Yoshida, Shuzo; Nagai, Koji; Son, Yonsu; Amuro, Hideki; Akashi, Koichi; Fujimura, Taku; Hirao, Makoto; Yamamoto, Keiichi; Shintani, Ayumi; Kumanogoh, Atsushi; Yoshikawa, Hideki

doi:10.1371/journal.pone.0194130

Cited by 73 publications

(81 citation statements)

References 37 publications

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“…Importantly, a relapse can also happen in patients treated with bDMARD standard doses. In the ANSWER cohort study, 20.9% of RA patients stopped bDMARDs by 36 months due to inefficacy in a real‐world setting . The incidence of disease relapse in the DT group of our present study was similar (21.4%).…”

Section: Discussionsupporting

confidence: 65%

Dose down‐titration of biological disease‐modifying antirheumatic drugs in daily clinical practice: Shared decision‐making and patient treatment preferences in Japanese patients with rheumatoid arthritis

et al. 2019

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Aim:To determine characteristics of rheumatoid arthritis (RA) patients in Japan who received the same biological disease-modifying antirheumatic drugs (bDMARDs) for at least 6 months and to identify factors associated with successful down-titration of bDMARDs dependent on shared decision-making. Methods:We included consecutive RA patients who received the same bDMARD with low disease activity or remission for at least 6 months in our two university hospitals. Patients treated with the bDMARD standard dose were defined as SD, while those treated with bDMARD down-titration were defined as DT. We retrospectively reviewed clinical charts and compared data between the two groups.Results: Of 288 patients with RA, 204 (70.8%) and 84 (29.2%) continued standard dose treatment and underwent down-titration treatment, respectively. Sixty-six of 84 (78.6%) down-titration-treated patients continued to show low disease activity or remission, whereas 18 (21.4%) relapsed 18.9 ± 24.4 months after bDMARD down-titration was started. Univariate predictor analysis showed that the probable factors of down-titration were no history of bDMARD treatment (P = .001) and low initial Disease Activity Assessment of 28 joint score (P = .048). Other clinical characteristics had no significant relationship with successful down-titration.Conclusions: Thus, bDMARD-naïve patients and those with low initial disease activity are more likely to agree to attempt down-titration. However, the timing and method of down-titration should be made in shared decision-making between patients and rheumatologists. K E Y W O R D Santirheumatic agents, arthritis-rheumatoid, decision-making, guideline, therapeutics

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Section: Discussionsupporting

confidence: 65%

Dose down‐titration of biological disease‐modifying antirheumatic drugs in daily clinical practice: Shared decision‐making and patient treatment preferences in Japanese patients with rheumatoid arthritis

et al. 2019

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“…Patients need to maintain long-term treatment to continue benefitting from the improvements achieved with these drugs. However, it has been reported that, after 4 years, up to 50% of patients discontinue treatment [1], generally because of a lack of efficacy, but also because of adverse events or personal preference [2].…”

Section: Introductionmentioning

confidence: 99%

Factors associated with long-term retention of treatment with golimumab in a real-world setting: an analysis of the Spanish BIOBADASER registry

et al. 2018

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The retention rate of a biological drug (percentage of patients remaining on treatment over time) provides an index of a drug's overall effectiveness. The golimumab retention rate as first-line biological therapy was high in clinical trial extensions lasting 5 years. Real-world studies also indicate good retention rates but have been of shorter duration. The probability of retention with golimumab treatment was assessed, as any line of anti-tumor necrosis factor-alpha therapy, for up to 5 years in patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA) or psoriatic arthritis (PsA), associated factors were analyzed. A retrospective database analysis of the Spanish registry of patients with rheumatic disorders receiving biological drugs (BIOBADASER) was performed. Among 353 patients, 29.8% had RA, 41.6% SpA and 28.6% PsA. Golimumab was the first biological drug in 40.1% of patients, second in 30.1% and third/later in 29.8%. The overall probability of retention of golimumab at years 1, 2, 3, 4 and 5 was 85.9% (95% confidence interval 81.4-89.5%), 73.7% (67.1-79.1%), 68.5% (60.5-75.1%), 60.6% (50.2-69.5%) and 57.1% (44.9-67.5%), respectively. Retention was similar across indications (p = 0.070) but was greater when golimumab was used as the first biological agent compared with later therapy lines (p < 0.001). Factors associated with higher retention of golimumab treatment (Cox regression) were use as a first-line biological and concomitant methotrexate treatment; corticosteroid need was associated with lower retention. The long-term probability of golimumab retention was high in this real-world study of patients with rheumatic diseases, especially when used as the first biological drug.

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“…While the previously mentioned factors interfere with a patient's ability to achieve remission and/or the desired level of disease activity via physiological mechanisms, they can also interfere with a patient's ability and/or willingness to adhere to a treatment regimen. Previous examinations of drug retention rates show that patients terminate therapy due to reasons of toxicity and/or lack of efficacy [14][15][16]. Moreover, initiation of treatment and medication adherence is also influenced by the cost of these therapies.…”

Section: Introductionmentioning

confidence: 99%

Berberine delays onset of collagen induced arthritis through T cell suppression

Vita¹,

Lyons²,

Aljobaily³

et al. 2019

Preprint

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RUNNING TITLE (less than 50 characters): Berberine delays onset of collagen arthritis model KEY WORDS (5 words not in the title): CIA, berberine, RA, autoimmune, T cell ABSTRACT (250 words or less): Previous evidence suggests that berberine (BBR), a clinically relevant plant-derived alkaloid, alleviates symptoms of clinically apparent collagen induced arthritis (CIA), and may have a prophylactic role from in vitro studies. Thus, we used a CIA model to determine if BBR merits further exploration as a prophylactic treatment for rheumatoid arthritis. Mice were treated with either 1 mg/kg/day of BBR or a vehicle (PBS) control via IP injections from day 0 to day 28, were left untreated (CIA control), or were in a non-arthritic control group. Incidence of arthritis in BBR mice was 40%, compared to 90% in the CIA and 80% in the PBS controls. Populations of B cells and T cells from the spleens and draining lymph nodes were examined from mice across treatment groups on day 14 and from the remaining mice on day 28 when arthritic signs and symptoms were expected to be apparent. BBR-treated mice had significantly reduced populations of CD4 + T cells, CXCR5 + T fh cells, and an increased proportion of T reg at both day 14 and day 28 endpoints, as well as decreased CD28 + and CD154 + CD4 + T cells at day 14. BBR-treated mice also experienced a significant reduction of CD19 + B cells in LNs at day 28. Additionally, BBR treatment resulted in significantly lower anti-collagen type II-specific (anti-CII) IgG2a and anti-CII total IgG serum concentrations. These results indicate a potential role for BBR as a prophylactic supplement, and that its effect may be mediated through T cell suppression, which indirectly affects B cell activity. and PBS controls ( Fig. 2B). When comparing anti-CII IgG levels between arthritic and nonarthritic mice within the BBR group specifically, however, anti-CI IgG1, IgG2a and total IgG were all significantly reduced in the non-arthritic mice compared to those who developed arthritis (Fig. 2C). Additionally, there appeared to be a vehicle-specific effect on circulating anti-CII IgG in which the administration of PBS with 0.01% DMSO elicited elevated levels of anti-CII IgG1 and total IgG in vehicle control mice ( Fig. 2A-B).Key CD4 + T cell population characteristics in response to berberine treatment-On day 14, we observed a significant reduction in populations of both CD4 + T cells and CXCR5 + T fh cells in the LNs and spleen of BBR-treated mice (Fig. 3A-B), as well as a reduction in the percentage of CD28 + and CD154 + CD4 + T cells in the spleen and LNs of BBR-treated mice (Fig. 3A-B). By the day 28 experimental endpoint we continued to observe a significant reduction in CD4 + T cells and CXCR5 + T fh cells in the spleen and LNs of BBR-treated mice ( Fig. 3C-D), however, there was no significant difference in the percentage of CD28 + and CD154 + CD4 + T cells between treatment groups (Fig 3C-D). Berberine treatment leads to increased proportion of FOXP3 + CD25 + CD4 + T cells-To examineBBRs effect on ...

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Drug retention and discontinuation reasons between seven biologics in patients with rheumatoid arthritis -The ANSWER cohort study-

Cited by 73 publications

References 37 publications

Dose down‐titration of biological disease‐modifying antirheumatic drugs in daily clinical practice: Shared decision‐making and patient treatment preferences in Japanese patients with rheumatoid arthritis

Dose down‐titration of biological disease‐modifying antirheumatic drugs in daily clinical practice: Shared decision‐making and patient treatment preferences in Japanese patients with rheumatoid arthritis

Factors associated with long-term retention of treatment with golimumab in a real-world setting: an analysis of the Spanish BIOBADASER registry

Berberine delays onset of collagen induced arthritis through T cell suppression

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