scholarly journals POS0674 DIRECT COMPARISON OF EFFECTIVENESS AND SAFETY OF TOFACITINIB AND BARICITINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS IN REAL-WORLD SETTINGS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 581.3-581
Author(s):  
N. Iwamoto ◽  
T. Suzuki ◽  
A. Okada ◽  
K. Fujikawa ◽  
T. Aramaki ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Propensity Score ◽  
Disease Activity ◽  
Clinical Response ◽  
Treatment Response ◽  
Real World ◽  
Jak Inhibitors ◽  
Low Disease Activity ◽  
Real World Setting ◽  
Significant Difference

Background:Tofacitinib is a non-selective first-generation JAK inhibitor and baricitinib was approved for the treatment of Rheumatoid arthritis several years after approve of tofacitinib. Randomized controlled trials have shown good treatment response for RA in these two drugs. However, the evaluation of these two drugs in real-world setting have been rarely reported, moreover, until now, no published data of a direct comparison among JAK inhibitors in RA have been available.Objectives:To compare the efficacy and safety of the JAK inhibitors tofacitinib and baricitinib in patients with rheumatoid arthritis (RA) by using propensity score matching in a real-world setting.Methods:A total of 242 patients with RA who were treated with tofacitinib (n=161) or baricitinib (n=81) were enrolled. To avoid confounding, we performed propensity score matching based on multiple baseline characteristic variables, and then 80 baricitinib-treated patients and 57 tofacitinib-treated patients were extracted for the direct comparison. A mixed effect model with a repeated measures analysis of variance (ANOVA) was performed to ascertain whether there were significant differences in clinical efficacy between the two treatment groups during the treatment period.Finally, We evaluated the predictive factor of clinical responses by performing univariate and multivariable logistic regression analyses.Results:The mean delta disease activity scores (DAS)28-ESR from baseline to 6 months were −1.60 (tofacitinib) and −1.46 (baricitinib). The remission rate defined by the DAS28-ESR at 24 weeks were 21.1% (tofacitinib) and 25.0% (baricitinib). There was no significant difference in the clinical response between the baricitinib-treated and tofacitinib-treated groups. Although there was no significant difference, the concomitant use of methotrexate (MTX) showed better clinical efficacy in the cases of baricitinib treatment as compared with in the case of tofacitinib treatment. In both groups, the most common AE was herpes zoster infection, and the AE rates were similar between the two groups. However, the predictive factors contributing to clinical response differed. The concomitant use of oral steroid was independently associated with the achievement of DAS-low disease activity in both groups, whereas in the baricitinib group, the number of biological and/or targeted synthetic DMARDs previously used and the DAS28-ESR at the time of initiation were associated with DAS-low disease activity.Conclusion:This study indicate that tofacitinib and baricitinib had comparable efficacies and safety profiles in a real-world setting. However, the influence of clinical characteristics on the treatment response differed between these two drugs. Direct comparison between two JAK inhibitors provide useful information to optimal use of JAK inhibitors in real-world settings.Disclosure of Interests:None declared

scholarly journals Real-World Comparative Effectiveness and Safety of Tofacitinib and Baricitinib in Patients with Rheumatoid Arthritis

2021 ◽  
Author(s):  
Naoki Iwamoto ◽  
Shuntaro Sato ◽  
Shota Kurushima ◽  
Toru Michitsuji ◽  
Shinya Nishihata ◽  
...  
Keyword(s):  
Disease Activity ◽  
Clinical Response ◽  
Real World ◽  
Oral Steroid ◽  
Baseline Characteristic ◽  
Low Disease Activity ◽  
Logistic Analysis ◽  
Significant Difference ◽  
Synthetic Dmards ◽  
The Mean

Abstract Objective: To compare the efficacy and safety of tofacitinib and baricitinib in patients with RA in a real-world setting.Methods: A total of 242 patients with RA who were treated with tofacitinib (n=161) or baricitinib (n=81) were enrolled. To avoid confounding, we performed propensity score matching based on multiple baseline characteristic variables, and then 80 baricitinib-treated patients and 57 tofacitinib-treated patients were extracted for direct comparison. Their clinical disease activity and AEs were evaluated for 24 weeks. Results: The mean DAS28-ESR change from baseline to 24 weeks were 1.60 (tofacitinib) and 1.46 (baricitinib). There was no significant difference in the clinical response between two groups. The efficacy was not significantly changed in the patients without concomitant MTX use in both groups, but the concomitant MTX use showed better clinical efficacy in the cases of baricitinib treatment. In both groups, the most common AE was herpes zoster infection, and the AE rates were similar between the two groups. However, the predictive factors contributing to clinical response as revealed by a multivariable logistic analysis differed. The concomitant oral steroid use was independently associated with the achievement of DAS-low disease activity in both groups, whereas in the baricitinib group, the number of biological and/or targeted synthetic DMARDs previously used was also associated. Conclusions: Our findings indicate that tofacitinib and baricitinib had comparable continuing efficacies and safety profiles. However, the influence of clinical characteristics on the treatment response differed. Direct comparison provides useful information to optimal use of JAK inhibitors in real-world settings.

scholarly journals Real-world comparative effectiveness and safety of tofacitinib and baricitinib in patients with rheumatoid arthritis

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Naoki Iwamoto ◽  
Shuntaro Sato ◽  
Shota Kurushima ◽  
Toru Michitsuji ◽  
Shinya Nishihata ◽  
...  
Keyword(s):  
Disease Activity ◽  
Clinical Response ◽  
Real World ◽  
Oral Steroid ◽  
Efficacy And Safety ◽  
Low Disease Activity ◽  
Logistic Analysis ◽  
Significant Difference ◽  
Synthetic Dmards ◽  
Multivariable Analyses

Abstract Objective To compare the efficacy and safety of tofacitinib and baricitinib in patients with RA in a real-world setting. Methods A total of 242 patients with RA who were treated with tofacitinib (n = 161) or baricitinib (n = 81) were enrolled. We evaluated efficacy and safety between tofacitinib and baricitinib using multivariable analyses to avoid confounding. Their clinical disease activity and AEs were evaluated for 24 weeks. Results The mean (SD) DAS28-ESR change from baseline to 24 weeks was 1.57 (1.55) (tofacitinib) and 1.46 (1.36) (baricitinib). There was no significant difference in the clinical response between the two groups (adjusted mean difference, 0.04; 95% CI, −0.35 to 0.28). The efficacy was not significantly changed in the patients without concomitant MTX use in both groups, but the concomitant MTX use showed better clinical efficacy in the cases of baricitinib treatment. In both groups, the most common AE was herpes zoster infection, and the AE rates were similar between the two groups. However, the predictive factors contributing to clinical response as revealed by a multivariable logistic analysis differed. The concomitant oral steroid use was independently associated with the achievement of DAS-low disease activity in the tofacitinib group, whereas in the baricitinib group, the number of biological and/or targeted synthetic DMARDs previously used was associated. Conclusions Our findings indicate that tofacitinib and baricitinib had comparable continuing efficacies and safety profiles. However, there is a possibility that the influence of clinical characteristics on the treatment response differs. The comparison provides useful information to the optimal use of JAK inhibitors in real-world settings.

scholarly journals SAT0153 GENDER DOES NOT INFLUENCE CLINICAL RESPONSE TO JAK INHIBITORS IN RHEUMATOID ARTHRITIS: AN ITALIAN MULTICENTRE ANALYSIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1016.2-1017
Author(s):  
F. R. Spinelli ◽  
M. S. Chimenti ◽  
M. Vadacca ◽  
C. Iannuccelli ◽  
P. Conigliaro ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clinical Response ◽  
Social Impact ◽  
Disease Duration ◽  
Female Gender ◽  
Clinical Feature ◽  
Jak Inhibitors ◽  
Low Disease Activity ◽  
Men And Women

Background:Gender medicine aims at describing how diseases differ between men and women in terms of epidemiology, clinical feature, therapeutic approach, treatment response and prognosis, psychological and social impact. Rheumatoid Arthritis (RA) affects women 2-3 times more than men. Female gender seems to be independently associated to a more refractory disease and a worst response to conventional synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) and biological DMARDs. Male patients achieve remission more often than females probably due to the higher number of tender joints reported by the latter.Objectives:In the light of the effect of Janus kinases inhibitors (JAKi) on pain, the objective of the study was to investigate whether gender might affect the achievement of remission or low disease activity in RA patients treated with baricitinib and tofacitinib.Methods:We performed a multicentric, prospective study on consecutive patients starting one of the two available JAKi: baricitinib and tofacitinib. Demographic and clinical data were recorded in a dedicate database and included: gender, age, disease duration, serological status (Rheumatoid Factor – RF; anti-citrullinated peptide antibodies, ACPA) number of previous csDMARDs and bDMARDs, number of tender joints (TJ) and swollen joints (SJ), C reactive protein (CRP); patient global assessment (PGA) and pain were recorded on a 0-100 mm visual-analogue scale (VAS). Disease activity score (DAS) 28 was calculated at baseline and at two follow-up visits (after 3-4 months and after 6-8 months). Data were expressed as mean±standard deviation or median (interquartile range) according to variables’ distribution. Continuous variables were compared by Mann Whitney test while dichotomous ones by Chi-squared test; p value < 0.05 were considered statistically significant.Results:We enrolled 182 RA patients (149 F:33 M) with similar age (F 58±12 vs M 60±10) and disease duration (F 143±101 vs M 147±105 months). Females and males were previously treated with the same number of csDMARDs [2(2)] but female have previously received numerically more bDMARDs [2(3) vs 1(2)]. At the 3 timepoints females and males showed similar number of TJ, SJ, similar values of CRP, PGA and pain. We did not observe any difference in percentage of males and females achieving remission or low disease activity according to gender (figure 1A) nor in terms of reduction of TJ, SJ and PGA; only pain decreased significantly more in male than in female patients at both timepoints (figure 1B).Conclusion:In RA patients treated with JAK inhibitors, even if the effect of JAKi on pain seems to be more relevant in male than in female, gender seems not to influence the overall clinical response, allowing men and women the same probability of reaching the therapeutic targetReferences:Disclosure of Interests:Francesca Romana Spinelli Grant/research support from: Pfizer, Speakers bureau: Lilly, BMS, Celgene, Maria Sole Chimenti: None declared, Marta Vadacca: None declared, Cristina Iannuccelli: None declared, Paola Conigliaro: None declared, Silvia Laura Bosello: None declared, Fulvia Ceccarelli: None declared, Cristina Garufi: None declared, Giulia Raffone: None declared, Paola Di Noi: None declared, Dario Bruno: None declared, Antonella Afeltra: None declared, Roberto Perricone: None declared, fabrizio conti Speakers bureau: BMS, Lilly, Abbvie, Pfizer, Sanofi, Elisa Gremese Speakers bureau: Abbvie, BMS, Celgene, Jannsen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB

scholarly journals Switching first-line targeted therapy after not reaching low disease activity within 6 months is superior to conservative approach: a propensity score-matched analysis from the ATTRA registry

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Lucie Nekvindová ◽  
Jiří Vencovský ◽  
Karel Pavelka ◽  
Pavel Horák ◽  
Zlatuše Křístková ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Targeted Therapy ◽  
Propensity Score ◽  
Disease Activity ◽  
Treatment Response ◽  
Daily Clinical Practice ◽  
Current Therapy ◽  
First Line ◽  
Treatment Target ◽  
Low Disease Activity

Abstract Background Treat-to-target (T2T) is a widely accepted strategy for patients with rheumatoid arthritis (RA). It recommends attaining a goal of at least low disease activity (LDA) within 6 months; otherwise, the current therapy should be modified. We aimed to investigate whether switching a first-line targeted therapy (TT) in patients not reaching LDA within 6 months leads to a higher probability of meeting LDA at the 12-month visit in daily clinical practice using data from Czech registry ATTRA. Methods We included patients with RA starting the first-line TT from 1 January 2012 to 31 January 2017 with at least 1-year follow-up. We created four mutually exclusive cohorts based on (1) switching to another TT within the first year and (2) reaching a treatment target (DAS28-ESR ≤ 3.2) at the 6-month visit. The primary outcome was the comparison of odds for reaching remission (REM) or LDA at the 12-month visit between patients switching and not switching TT after not reaching treatment target at 6 months. Before using logistic regression to estimate the odds ratio, we employed the propensity score to match patients at the 6-month visit. Results A total of 1275 patients were eligible for the analysis. Sixty-two patients switched within the first 5 months of the treatment before evaluating treatment response at the 6-month visit (C1); 598 patients reached the treatment target within 6 months of therapy (C2); 124 patients did not reach treatment response at 6-month visit and switched to another therapy (C3), and 491 patients continued with the same treatment despite not reaching LDA at the 6-month visit (C4). We matched 75 patients from cohort C3 and 75 patients from C4 using the propensity score. Patients following the T2T principle (C3) showed 2.8 (95% CI 1.4–5.8; p = 0.005) times increased likelihood of achieving REM/LDA at the 12-month visit compared to patients not following the T2T strategy (C4). Conclusions In daily clinical practice, the application of the T2T strategy is underused. Switching TT after not reaching REM/LDA within the first 6 months leads to a higher probability of achieving REM/LDA in RA patients at the 12-month visit.

scholarly journals POS0455 EFFECT OF ANTI-Ro/SSA ANTIBODIES FOR TREATMENT RESPONSE TO METHOTREXATE IN RHEUMATOID ARTHRITIS: A RETROSPECTIVE MULTICENTER OBSERVATIONAL STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 458.1-458
Author(s):  
R. Yokochi ◽  
H. Tamai ◽  
T. Kido ◽  
Y. Yagyu ◽  
D. Waki ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Disease Activity ◽  
Clinical Response ◽  
Logistic Regression Analysis ◽  
Age At Onset ◽  
Treat To Target ◽  
Low Disease Activity ◽  
Target Strategy

Background:Several previous observational studies have suggested that patients with anti-Ro/SSA antibody-positive rheumatoid arthritis (RA) may respond poorly to treatment, including tumor necrosis factor inhibitors1. However, its influence on methotrexate (MTX) treatment, which is the anchor drug of treat-to-target strategy in RA treatment, remains unclear.Objectives:We compared the clinical response to MTX in both anti-Ro/SSA antibody-positive and -negative patients with MTX-naiive RA and investigated the reasons for the difference in response.Methods:We recruited 210 consecutive patients with RA who were newly started on MTX in this retrospective cohort study. The effect of the presence of anti-Ro/SSA antibodies on achieving low disease activity (LDA) of DAS28-CRP at six months after initiating MTX was investigated by using logistic regression analysis. CDAI, SDAI, concomitant using DMARDs and painkillers, patient’s and evaluator’s VAS, tender joint counts, and swollen joint counts at six months were also compared between the anti-Ro/SSA-positive patients and -negative patients. Missing data were imputed by using multiple imputations before multivariate analysis.Results:32 anti-Ro/SSA antibody-positive patients and 178 anti-Ro/SSA antibody-negative patients were included. The rate of achieving DAS28-LDA at six months was significantly lower in the anti-Ro/SSA antibody-positive patients than those in the anti-Ro/SSA antibody-negative patients (56.2% versus 75.8%, P=0.03). in the logistic regression analysis, the presence of anti-Ro/SSA antibodies was an independent negative predictor for achieving DAS-28-LDA at six months (OR:0.431, 95%CI: 0.190-0.978, P=0.044) (Table1). Anti-Ro/SSA antibody-positive patients had significantly higher patient’s VAS at six months (median [IQR]: 22 [15-41] vs 19 [5-30], P=0.038), and prescribed NSAIDs (37.5% vs 18.0%, P=0.018). CDAI and SDAI after six months were not significantly different between the group.Conclusion:The presence of anti-Ro/SSA antibodies might be one of the predictive factors for the insufficient response to treat to target strategy in RA treatment. Residual pain was suspected as one of the mechanisms contributing to the lesser clinical response of MTX in anti-Ro antibody-positive RA.References:[1]Ran Matsudaira wt al. J Rheumatol 2011;38(11):2346-54Table 1.Logistic regression analysis for the rate of achieving DAS28 low disease activity at six months.Risk factor Odds ratio95%CIP valueAge at onset0.9930.968-1.0180.586Sex (woman)0.6430.300-1.3840.258RF-positive1.9620.853-4.5110.112ACPA-positive0.5520.225-1.3510.192Anti-Ro/SSA antibody-positive0.4310.190-0.9780.044Disclosure of Interests:None declared

Early clinical response predicts low disease activity at one year in rheumatoid arthritis patients on treatment with certolizumab in real-life settings. An appraisal of the Italian registry GISEA

2016 ◽  
Vol 83 (6) ◽  
pp. 721-725 ◽  
Author(s):  
Florenzo Iannone ◽  
Giorgio Carlino ◽  
Antonio Marchesoni ◽  
Piercarlo Sarzi-Puttini ◽  
Roberto Gorla ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clinical Response ◽  
Real Life ◽  
Low Disease Activity ◽  
One Year

scholarly journals Clinical Response Within 12 Weeks as a Predictor of Future Low Disease Activity in Patients with Early RA: Results from the TEAR Trial

2013 ◽  
Vol 40 (5) ◽  
pp. 572-578 ◽  
Author(s):  
Jeffrey R. Curtis ◽  
Theresa McVie ◽  
Ted R. Mikuls ◽  
Richard J. Reynolds ◽  
Iris Navarro-Millán ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clinical Response ◽  
Model Building ◽  
Prediction Models ◽  
Characteristic Curve ◽  
Prediction Rule ◽  
Low Disease Activity ◽  
Derivation Cohort ◽  
Early Ra

Objective.Rapidly predicting future outcomes based on short-term clinical response would be helpful to optimize rheumatoid arthritis (RA) management in early disease. Our aim was to derive and validate a clinical prediction rule to predict low disease activity (LDA) at 1 year among patients participating in the Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) trial escalating RA therapy by adding either etanercept or sulfasalazine + hydroxychloroquine [triple therapy (TT)] after 6 months of methotrexate (MTX) therapy.Methods.Eligible subjects included in the derivation cohort (used for model building, n = 186) were participants with moderate or higher disease activity [Disease Activity Score 28-erythrocyte sedimentation rate (DAS-ESR) > 3.2] despite 24 weeks of MTX monotherapy who added either etanercept or sulfasalazine + hydroxychloroquine. Clinical characteristics measured within the next 12 weeks were used to predict LDA 1 year later using multivariable logistic regression. Validation was performed in the cohort of TEAR patients randomized to initially receive either MTX + etanercept or TT.Results.The derivation cohort yielded 3 prediction models of varying complexity that included age, DAS28 at various timepoints, body mass index, and ESR (area under the receiver-operator characteristic curve up to 0.83). Accuracy of the prediction models ranged between 80% and 95% in both derivation and validation cohorts, depending on the complexity of the model and the cutpoints chosen for response and nonresponse. About 80% of patients could be predicted to be responders or nonresponders at Week 12.Conclusion.Clinical data collected early after starting or escalating disease-modifying antirheumatic drug/biologic treatment could accurately predict LDA at 1 year in patients with early RA. For patients predicted to be nonresponders, treatment could be changed at 12 weeks to optimize outcomes.

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