scholarly journals POS0616 LONG-TERM EFFECTIVENESS AFTER MULTIPLE CYCLES WITH RITUXIMAB FOLLOWING AN ON-FLARE RETREATMENT STRATEGY IN PATIENTS WITH RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 545-546
Author(s):  
D. Bertrand ◽  
N. Pype ◽  
T. Conings ◽  
D. De Cock ◽  
S. Pazmino ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Global Health ◽  
Adverse Events ◽  
Disease Activity ◽  
University Hospital ◽  
C Cycle ◽  
Patient Reported ◽  
Efficacious Drug ◽  
Over Time

Background:Rituximab is known as an efficacious drug for the treatment of Rheumatoid Arthritis (RA). The recommended administration schedule consist of 2 infusions of 1000 mg with a 2-week interval. In Belgium an on-flare retreatment strategy is followed, making evaluation of effectiveness over time challenging. Moreover the patient’s view on this strategy is unclear.Objectives:To explore long-term effectiveness and safety of rituximab in daily clinical practice in patients with RA.Methods:Data of patients diagnosed with RA and treated with rituximab in a tertiary university hospital were retrospectively collected. For every cycle, clinical data were recorded at the time of the first and second infusion, the 16-week visit and the visit on which the treating rheumatologist decided to prescribe a new cycle. Data on demographics, previous RA treatment, disease activity, patient-reported outcomes, adverse events related to rituximab, dose and number of cycles were collected from 01/01/2006 until 01/12/2019 or until discontinuation of rituximab. The visit on which rituximab was prescribed for the first time was considered as the baseline visit. The data were analysed descriptively.Results:Data of 66 patients with RA were collected. The median (IQR) age was 57.0 (47.0-65.0) years at baseline and 56% (37/66) were female. Most patients were seropositive (RF 91% and ACPA 92%), and had erosive (71%) or nodular disease (53%). The median (IQR) disease duration was 12.5 (4.0-18.3) years. In total, 94% of the patients had failed at least one other biological Disease-modifying Antirheumatic Drug (bDMARD) before starting rituximab. Overall, patients received a median (IQR) of 3 (2-7) cycles of rituximab. Seven of the 66 patients (11%) discontinued rituximab and changed to another bDMARD after a median (IQR) of 1 (1-6) cycles and 11% were treated with a lower dose than 2x1000mg. The median (IQR) interval between the first 2 cycles was 7.0 (6.0-10.0) months, after which this increased to up to one year (interval between cycle 2-3: 10.0 (7.0-13.0) months, cycle 3-4: 12.0 (7.3-15.5) months). The overall median (IQR) follow-up time was 45.5 (14.8-82.3) months. The efficacy of rituximab remained after repeated cycles: after every treatment with rituximab, a reduction in disease activity based on the disease activity score in 28 joints (DAS28) could be noticed (figure 1A). The evolution in patients’ (PaGH) and physicians’ global health (PhGH) assessment followed the same pattern as the DAS28-score (Figure 1B). High PaGH-scores could be noticed at every start of a new rituximab cycle. The proportion of patients with a PaGH-score above 20 ranged from 84% - 100%, 74% - 100% and 66% - 86% at the first infusion, second infusion and week 16 visits, respectively. Rituximab was considered to be well-tolerated. In total, 23 adverse events in 12 patients were recorded and none of them were serious.Conclusion:Rituximab can be considered a highly efficacious drug for RA treatment in daily practice. There were no major side effects and there was an increasing treatment interval over time. However, a healthy survivor effect should be kept in mind when interpreting the results. It should be noted that with the on-flare retreatment strategy, every new rituximab cycle was preceded by a rise in PaGH-scores, which reflects a state of impaired wellbeing reported by patients. This should be further studied with qualitative methods and in a randomized trial setting comparing on-flare with fixed-interval retreatment to evaluate optimal effectiveness.Figure 1.Evolution in median - interquartile range disease activity (DAS28CRP) (A) and patients’ (PaGH) and physicians’ global health (PhGH) (B) over the different rituximab cycles. The disease activity, PaGH and PhGH were measured at baseline, the time of the first and second infusion, W16 and the visit on which a new rituximab cycle was prescribed. The dotted lines represent a DAS28CRP-score of 2.6 (remission cut-off) and 3.2 (low disease activity cut-off). C: cycle; W: week; VAS: visual analogue scale.Disclosure of Interests:None declared

scholarly journals Long-term effectiveness and safety of infliximab, golimumab and golimumab-IV in rheumatoid arthritis patients from a Canadian prospective observational registry

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Proton Rahman ◽  
Philip Baer ◽  
Ed Keystone ◽  
Denis Choquette ◽  
Carter Thorne ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Randomized Clinical Trials ◽  
Disease Duration ◽  
Routine Care ◽  
Treatment Modalities ◽  
The Mean ◽  
Over Time

Abstract Background Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. The objectives are to describe the profile of rheumatoid arthritis (RA) patients treated with anti-TNF agents in Canadian routine care. Methods RA patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or intravenous golimumab (GLM-IV) as per their respective Canadian product monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in disease activity. Safety was evaluated by the incidence of adverse events (AEs) and drug survival. Results Of the 890 IFX-, 530 GLM- and 157 GLM-IV-treated patients, the proportion of females ranged from 77.0–86.6%, the mean ages from 55.8–57.7 and the mean disease duration from 6.5–8.6 years. A significant decrease in baseline disease duration and disease activity parameters (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. Treatment with IFX, GLM- and GLM-IV significantly improved all disease parameters over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM- and GLM-IV-treated patients, respectively. Conclusion Differences in baseline characteristics between patients treated with an anti-TNFs over time shows the evolution of treatment modalities over time. All treatments significantly reduced disease activity and improved functionality in a similar fashion. The incidence of adverse events was consistent with the safety profiles of IFX and GLM. Trial registration ClinicalTrials.gov Identifier: NCT00741793 (Retrospectively registered on August 26, 2008).

scholarly journals Long-Term Effectiveness and Safety of Infliximab, Golimumab and Golimumab-IV in Rheumatoid Arthritis Patients from a Canadian Prospective Observational Registry

2020 ◽  
Author(s):  
Proton Rahman ◽  
Philip Baer ◽  
Ed Keystone ◽  
Denis Choquette ◽  
Carter Thorne ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Randomized Clinical Trials ◽  
Disease Duration ◽  
Routine Care ◽  
Treatment Modalities ◽  
The Mean ◽  
Over Time

Abstract Background: Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. The objectives are to describe the profile of rheumatoid arthritis (RA) patients treated with anti-TNF agents in Canadian routine care.Methods: RA patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or intravenous golimumab (GLM-IV) as per their respective Canadian product monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in disease activity. Safety was evaluated by the incidence of adverse events (AEs) and drug survival.Results: Of the 890 IFX-, 530 GLM-SC- and 157 GLM-IV-treated patients, the proportion of females ranged from 77.0-86.6%, the mean ages from 55.8-57.7 and the mean disease duration from 6.5-8.6 years. A significant decrease in baseline disease duration and disease activity parameters (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. Treatment with IFX, GLM-SC and GLM-IV significantly improved all disease parameters over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM-SC and GLM-IV-treated patients, respectively. Conclusion: Differences in baseline characteristics between patients treated with an anti-TNFs over time shows the evolution of treatment modalities over time. All treatments significantly reduced disease activity and improved functionality in a similar fashion. The incidence of adverse events was consistent with the safety profiles of IFX and GLM.Trial Registration: NCT00741793

scholarly journals Long-Term Effectiveness and Safety of Infliximab, Golimumab and Golimumab-IV in Rheumatoid Arthritis Patients from a Canadian Prospective Observational Registry

2020 ◽  
Author(s):  
Proton Rahman ◽  
Philip Baer ◽  
Ed Keystone ◽  
Denis Choquette ◽  
Carter Thorne ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Randomized Clinical Trials ◽  
Disease Duration ◽  
Routine Care ◽  
Treatment Modalities ◽  
The Mean ◽  
Over Time

Abstract Background Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. The objectives are to describe the profile of rheumatoid arthritis (RA) patients treated with anti-TNF agents in Canadian routine care. Methods RA patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or intravenous golimumab (GLM-IV) as per their respective Canadian product monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in disease activity. Safety was evaluated by the incidence of adverse events (AEs) and drug survival. Results Of the 890 IFX-, 530 GLM-SC- and 157 GLM-IV-treated patients, the proportion of females ranged from 77.0-86.6%, the mean ages from 55.8-57.7 and the mean disease duration from 6.5-8.6 years. A significant decrease in baseline disease duration and disease activity parameters (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. Treatment with IFX, GLM-SC and GLM-IV significantly improved all disease parameters over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM-SC and GLM-IV-treated patients, respectively. Conclusion Differences in baseline characteristics between patients treated with an anti-TNFs over time shows the evolution of treatment modalities over time. All treatments significantly reduced disease activity and improved functionality in a similar fashion. The incidence of adverse events was consistent with the safety profiles of IFX and GLM.

scholarly journals FRI0020 CLINICAL TREATMENT RESPONSE STILL DOES NOT MATCH PATIENT REPORTED IMPROVEMENT, EVEN IN EARLY RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 582.1-582
Author(s):  
S. Pazmino ◽  
A. Lovik ◽  
A. Boonen ◽  
D. De Cock ◽  
V. Stouten ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Early Rheumatoid Arthritis ◽  
Health Assessment ◽  
Sustained Remission ◽  
Research Support ◽  
Early Ra ◽  
Severity Scores ◽  
Patient Reported ◽  
Over Time

Background:Commonly used disease activity scores in rheumatoid arthritis (RA) include one patient reported outcome (PRO) -the patient’s global health assessment (PGA). Exploratory factor analysis (EFA) was performed on data from the 2 year Care in early Rheumatoid Arthritis (CareRA) trial to explain the evolution of disease burden extracting 3 factors.1Objectives:To assess the evolution and relative responsiveness over time of clinical, laboratory and patient assessments included in composite scores, together with other PROs like pain, fatigue and functionality in patients with early RA (≤1 year) treated to target (T2T) within the CareRA trial.Methods:DMARD naïve patients with early RA (n=379) were included, randomized to remission induction with COBRA-like treatment schemes (n=332) or MTX monotherapy (n=47) and T2T.Components of disease activity scores (swollen/tender joint count (S/TJC), C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), and physician (PhGH) or patient (PGA) global health assessment), pain and fatigue (both on 0-100 scale) and HAQ were recorded at every visit.Missing data was handled with multiple imputation (n=15). Clustering was removed with multiple outputation (n=1000), then each of the 15 000 datasets was analyzed by EFA with principal component extraction and oblimin rotation. The analyses were combined after re-ordering the factors by maximizing factor congruence. The 3 extracted factors and their individual components (with their loadings) were: 1. Patient containing PGA (0.87), pain (0.86), fatigue (0.90) and HAQ (0.5) 2.Clinical with SJC (0.92), TJC (0.89) and PhGH (0.76) and 3.Laboratory with CRP(0.87) and ESR (0.78).1(Pazmino, ACR 2019 abstract, Table 3)Afterwards, variables were first normalized to a 0-1 scale, then multiplied -weighted- by the factor loadings previously obtained.1For each Patient, Clinical and Laboratory severity score, the weighted variables belonging to each score were summed together and then re-scaled to 0-1 (higher values suggest more burden).The percentage (%) improvement from baseline to week 104 and the area under the curve (AUC) across time points were calculated per factor.Differences in % improvement and AUC were compared between patients not achieving and achieving early and sustained (week 16 to 104) disease activity score remission (DAS28CRP <2.6) with ANOVA. Bonferroni correction was used for multiple testing.Results:Severity scores of Patient, Clinical and Laboratory factors improved rapidly over time (Figure 1). In patients achieving sustained remission (n=122), Patient, Clinical and Laboratory scores improved 56%, 90% and 27% respectively. In patients not achieving sustained remission (n=257) the improvement was 32%, 78% and 9% respectively (p<0.001 only for clinical improvement).Patients in CareRA who achieved sustained remission had an AUC of 15.1, 3.4 and 4.7 in Patient, Clinical and Laboratory scores respectively, compared to 32.3, 10.0, and 7.2 in participants not achieving sustained remission (p<0.001 for all comparisons).Conclusion:Patient, Clinical and Laboratory severity scores improved rapidly over time in patients achieving rapid and sustained disease control. However, overall, Patient burden seemed not to improve to the same extent as Clinical burden. Patient’s unmet needs in terms of pain, fatigue, functionality and overall well-being should thus be given more attention, even in patients in sustained remission.References:[1]Pazmino S,et al.Including Pain, Fatigue and Functionality Regularly in the Assessment of Patients with Early Rheumatoid Arthritis Separately Adds to the Evaluation of Disease Status [abstract]. ACR. 2019.Disclosure of Interests:Sofia Pazmino: None declared, Anikó Lovik: None declared, Annelies Boonen Grant/research support from: AbbVie, Consultant of: Galapagos, Lilly (all paid to the department), Diederik De Cock: None declared, Veerle Stouten: None declared, Johan Joly: None declared, Delphine Bertrand: None declared, Rene Westhovens Grant/research support from: Celltrion Inc, Galapagos, Gilead, Consultant of: Celltrion Inc, Galapagos, Gilead, Speakers bureau: Celltrion Inc, Galapagos, Gilead, Patrick Verschueren Grant/research support from: Pfizer unrestricted chair of early RA research, Speakers bureau: various companies

scholarly journals The Relation Between Disease Activity, Patient‐Reported Outcomes, and Grip Force Over Time in Early Rheumatoid Arthritis

2019 ◽  
Vol 1 (8) ◽  
pp. 507-515
Author(s):  
Maria Rydholm ◽  
Ingegerd Wikström ◽  
Sofia Hagel ◽  
Lennart T. H. Jacobsson ◽  
Carl Turesson
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Early Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Grip Force ◽  
Patient Reported ◽  
Over Time

scholarly journals Is Tightly Controlled Disease Activity Possible with Online Patient-reported Outcomes?

2014 ◽  
Vol 41 (4) ◽  
pp. 640-647 ◽  
Author(s):  
Margot J. Walter ◽  
S.H. Mohd Din ◽  
Johanna M. Hazes ◽  
E. Lesaffre ◽  
P.J. Barendregt ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Cross Validation ◽  
Activity Index ◽  
Joint Modeling ◽  
Joint Disease ◽  
Rheumatoid Arthritis Disease ◽  
Patient Reported ◽  
Over Time

Objective.To evaluate the performance of patient-reported outcomes (PRO) as primary indices for identification and prediction of a 28-joint Disease Activity Score (DAS28) > 3.2 among patients with rheumatoid arthritis (RA).Methods.Patients with RA completed monthly online PRO [Health Assessment Questionnaire (HAQ), Rheumatoid Arthritis Disease Activity Index (RADAI), visual analog scale (VAS) fatigue] and were clinically assessed every 3 months using the DAS28. Simple descriptive statistics, logistic regression, and the Bayesian joint modeling approach were used to analyze the data. The Bayesian joint model combines the scores and changes in the scores of 3 PRO to predict a DAS28 > 3.2 at the subsequent timepoint.Results.A group of 159 patients with RA participated. Stratified summaries of the PRO by DAS28 categories at baseline provided incremental values of the PRO for more active disease. However, on an individual level, the DAS28 and the PRO fluctuated over time. The prediction of subsequent DAS score by a single instrument at single timepoints resulted in moderate sensitivity and specificity. Using the intercept and slope of the combined PRO of the first 3 measurements to predict the DAS28 state at 3 months resulted in a sensitivity of 0.81 and a specificity of 0.92. After 10-fold cross validation, the model had a sensitivity of 0.61 and specificity of 0.75 to identify patients with a DAS28 > 3.2.Conclusion.PRO showed fluctuating levels of disease activity over time, while on a group level disease activity stayed the same. Using the changes in RADAI, HAQ, and VAS fatigue over time to predict future DAS28 > 3.2 resulted in moderate performance after the internal cross-validation of the model (sensitivity 0.61, specificity 0.75).

scholarly journals Cotreatment with methotrexate in routine care patients with rheumatoid arthritis receiving biological treatment yields better outcomes over time

RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000836 ◽  
Author(s):  
Niels W. Boone ◽  
Alexandre Sepriano ◽  
Paul-Hugo van der Kuy ◽  
Rob Janknegt ◽  
Ralph Peeters ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Combination Therapy ◽  
Disease Activity ◽  
Estimating Equation ◽  
Routine Care ◽  
Patient Reported Outcome ◽  
Joint Disease ◽  
Continuous Variables ◽  
Patient Reported ◽  
Over Time

ObjectivesWe aimed to evaluate the effects of methotrexate (MTX) comedication added to biological disease-modifying antirheumatic drugs (bDMARD) on disease activity measures in patients with rheumatoid arthritis (RA) in routine care.MethodsPatients with RA on treatment with either bDMARDs or conventional synthetic DMARDs were included in this prospective cohort study. The effect of (time-varying) combination therapy with bDMARD and MTX compared with bDMARD monotherapy was tested in longitudinal generalised estimating equation models using as outcomes: (1) the likelihood to be in remission according to the 28-joint Disease Activity Score (DAS28) erythrocyte sedimentation rate (ESR) (<2.6) and to the Routine Assessment of Patient Index Data 3 (RAPID3) (0–30; ≤3), a patient-reported outcome measure about RA symptoms; and (2) DAS28-ESR and RAPID3 as continuous variables. All models were adjusted for potential confounders: age, gender, drugs for comorbidities (yes/no), oral steroids (yes/no) and non-steroidal anti-inflammatory drug (yes/no).ResultsIn total, 330 patients were included (mean (SD) follow-up; 10.7 (9.7) months). Compared with bDMARD monotherapy, MTX combination therapy was significantly associated with a 55% higher likelihood to be in DAS28 remission, but not RAPID3 remission, over time. Combination therapy resulted in slightly, but statistically significant, lower levels of DAS28-ESR over time (β=−0.42 (95% CI −0.67 to − 0.17)), but not RAPID3 (β=−0.58 (95% CI −0.65 to 0.49)). The effect on DAS28-ESR was entirely explained by lower swollen joint counts and was persistent after correction for confounders.ConclusionThese results give support to the policy that MTX should be continued in routine care patients with RA on biological therapy since this leads to better objective but not subjective clinical outcomes

scholarly journals AB0272 CAN NONSTEROIDAL ANTI-INFLAMMATORY DRUGS CONTROL THE SYMPTOMS OF MODERATE RHEUMATOID ARTHRITIS?

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1162.2-1162
Author(s):  
E. Pogozheva ◽  
A. Karateev ◽  
V. Amirdzhanova ◽  
E. Filatova
Keyword(s):  
Rheumatoid Arthritis ◽  
Global Health ◽  
Disease Activity ◽  
Biological Agents ◽  
Das 28 ◽  
Moderate Disease ◽  
Inflammatory Drugs ◽  
Moderate Disease Activity

Objectives:to evaluate the efficacy of long-term pain therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with rheumatoid arthritis (RA) with an initially moderate disease activity (DAS 28 <5,1).Methods:the study included 404 RA patients, disease duration was more than 1 year, mean DAS 28 3.7±1.6, mean age 58.6±10.0 years, 69% women, 76,7% RF “+”, 81,5% ACPA “+”. 91,2% of the patients received conventional DMARDs (methotrexate), 8,8% - biological agents. All patients received NSAIDs (aceclofenac) to control their symptoms. Тhe follow-up period was 6 months. We evaluated the dynamics of the DAS 28 index, the level of pain and patient global health on a 100- mm visual analog scale (VAS).Results:the level of pain (VAS) decreased from 63,1 ± 15,4 to 46,3± 8,3 (p=0,001) by 3 months of follow-up and up to 39,5± 11,2 (p= 0,001) by 6 months of follow-up. The patient global health (VAS) also improved from 58,2 ± 13,4 at baseline to 40,3 ± 11,2 (p=0,001) at 3 months and to 35,5 ± 9,7 (p=0,001) at 6 months of follow up. The mean DAS 28 remained within the moderate disease activity and decreased from 3,7±1,5 to 3,4 ±1,1 (p=0,01) after 3 months, and to 3,1± 0,9 (p=0,01) after 6 months.Conclusion:long-term NSAID therapy allows to control the disease activity in patients with moderate RA. This should be taken into account when planning therapy, including deciding whether to “switch” DMARDs and prescribing biological agents.Disclosure of Interests:None declared

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