Can treating rheumatoid arthritis with disease-modifying anti-rheumatic drugs at the window of opportunity with tight control strategy lead to long-term remission and medications free remission in real-world clinical practice? A cohort study

2021 ◽  
Author(s):  
Sanaz Ebrahimian ◽  
Amin Salami ◽  
Aida Malek Mahdavi ◽  
Kamal Esalatmanesh ◽  
Alireza Khabbazi ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cohort Study ◽  
Clinical Practice ◽  
Real World ◽  
Control Strategy ◽  
Window Of Opportunity ◽  
Tight Control ◽  
Disease Modifying

scholarly journals AB0224 SUSTAINABLE LOW DISEASE ACTIVITY IN PATIENTS WITH RHEUMATOID ARTHRITIS: REAL-WORLD EXPERIENCE WITH TOCILIZUMAB

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1138.1-1138
Author(s):  
T. Shivacheva ◽  
T. Georgiev ◽  
S. Hristova ◽  
S. Dimitrov ◽  
S. Bogdanova-Petrova ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
Disease Activity ◽  
Real World ◽  
Long Term Results ◽  
Sustained Remission ◽  
Low Disease Activity ◽  
The Mean ◽  
Concomitant Hypertension

Background:Sustainability, the ability of drugs to maintain remission or low disease activity (LDA) in patients with rheumatoid arthritis (RA), plays a crucial role for the prevention of structural damage to joints and thus, preserving patients’ functional capacity, health-related quality of life and general sense of well-being. Therefore, studying the sustainable effectiveness of tocilizumab (TCZ) as a monotherapy or combined with methotrexate (MTX) is important (1).Objectives:We aimed to examine to what extend TCZ, alone or combined with MTX, could achieve and further sustain LDA in patients with long-standing RA in the light of current, strictly index-based definitions of LDA and to compare the two versions of DAS28 in patients in real clinical practiceMethods:85 RA patients treated with TCZ for at least eighteen months were consecutively enrolled in the present single-center, retrospective cohort study. All participants met the 1987 ACR classification criteria and attended the rheumatology department of University Hospital “St. Marina” Varna in an outpatient setting. Patients receiving pre-filled syringe contained 162 mg TCZ once weekly subcutaneously. Real-world data were extracted and analyzed from patient’s full medical file. For each visit, disease activity score 28 with ESR and CRP (DAS28-ESR and DAS28-CRP) and simple disease activity index (SDAI) were calculated simultaneously according to generally adopted formulas. A twelve-month result was determined for sustained LDA at each of the patient’s three visits (at 6-month intervals), according to DAS28 and SDAI. Descriptive statistics, Chi square test, Cochran´s Q test, kappa statistic were used, a binary logistics model was compiled to study the impact. Significance level of p <0.05.Results:Two hundred fifty-five patient visits were analyzed. The mean durations of RA and treatment with TCZ were 12.6 (±9.6) years and 3.64 (±1.8) years, respectively. The mean age of patients was 60.3 years (37-87 years), 80% were women, 24.7% were obese, 65.9% have concomitant hypertension. 61.2% of patients are treated with combination therapy TCZ with MTX.Of all patients, these with a sustained 12-month LDA were 41.2%, 28.2% or 23.5% depending on the studied index (DAS28-CRP, SDAI, or DAS28-ESR, respectively).A 12-month SDAI LDA was found in a significantly small proportion of patients (28.2%, p = 0.001). The DAS28 ESR determined a proportion similar to SDAI (23.5%, p> 0.05), while according to the DAS28 CRP, patients with a sustained 12-month LDA were significantly more (41.2% p = 0.005). A moderate level of agreement was found between the assessments of SDAI and the two variants of DAC28 when determining 12-month results of Tocilizumab treatment (DAS28-ESR k = 0.511, p <0.001 and DAC28-CRP k = 0.618, p <0.001). No relationship was found between the combination of TCZ with MTX and the patients’ chance of a sustained 12-month LDA, regardless of which index the result was measured.Patients with hypertension were significantly less likely to have sustained 12-month LDA according to SDAI and DAS 28 ESR (OR 0.135, 95% CI 0.048-0.386; OR 0.313, 95% CI 0.111-0.882, respectively), but not according to DAS28 CRP.Conclusion:Sustained 12- month LDA with TCZ in patients with long-term RA remains uncommon in daily clinical practice. Co-administration of MTX is not associated with an increased likelihood of achieving a sustained LDA in the analysis of long-term responses. Patients with concomitant hypertension are less likely to be in a sustained 12-month LDA, according to SDAI and DAS28-ESR. The results according to DAS28 ESR, but not according to DAS28CRP are comparable to those of SDAI when measuring long-term results of treatment with TCZ.References:[1]Hamann PDH, Pauling JD, McHugh N, Shaddick G, Hyrich K; BSRBR-RA Contributors Group. Predictors, demographics and frequency of sustained remission and low disease activity in anti-tumour necrosis factor-treated rheumatoid arthritis patients. Rheumatology (Oxford). 2019 Dec 1;58(12):2162-2169.Disclosure of Interests:None declared

scholarly journals SAT0581 SERIOUS INFECTION RATES WITH BIOLOGICAL DISEASE MODIFYING ANTI-RHEUMATIC AGENTS (bDMARDs) AND PREDISPOSING FACTORS: A 5-YEAR RETROSPECTIVE REVIEW

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1249.1-1250
Author(s):  
K. Celkys ◽  
J. Ly ◽  
M. Soden
Keyword(s):  
Rheumatoid Arthritis ◽  
Real World ◽  
Retrospective Review ◽  
Total Duration ◽  
Predisposing Factors ◽  
Baseline Risk ◽  
Categorical Variables ◽  
Significant Difference ◽  
Disease Modifying ◽  
Tract Infections

Background:Biological and targeted synthetic disease modifying anti-rheumatic agents (bDMARDs) increase the risk of serious infections (SIs), however there is limited ‘real-world’ evidence comparing the relative risk of SI for individual bDMARDs. (1,2)Objectives:This study examines the rates of SIs in a non-select Australian Northern Queensland (NQ) cohort of patients with various rheumatic diseases receiving treatment with a bDMARD, to define predisposing factors and directly compare the bDMARDs.Methods:A retrospective review was performed for all patients who received a bDMARD through the Townsville Hospital Rheumatology Department over the 5-year period between June 2013 and May 2018. Episodes of a SI were defined as infection requiring admission or use of intravenous antibiotics. For each bDMARD the rate of SI per 100 patient years (PYs) was calculated and patient demographics and comorbidities were analysed. Between group differences were assessed using independent samples t-tests or ANOVA. Where assumptions were violated, Mann-Whitney U tests or Kruskal-Wallis tests were used. For categorical variables, chi-square tests were used, except when assumptions were violated when Fisher’s Exact tests were used.Results:296 patients received bDMARDs with an overall SI rate of 11.7/100PYs. There was no significant difference in presence of SI by disease type with 24% of patients with rheumatoid arthritis versus 19% with psoriatic arthritis, 14% with ankylosing spondylitis and 29% with “other” (X2=3.11; df=3; p=0.37). Respiratory tract infections were the most common infection (46%) followed by skin and soft tissue infections (23%). The highest incidence rate of SI occurred with rituximab (29.72 SI/100PYs) followed by certolizumab (22.50 SI/100PYs) and tocilizumab (15.00 SI/100PYs). Duration of time on a bDMARD, disease duration and use of methotrexate or leflunomide were not shown to significantly increase the risk of SI for the entire cohort. The characteristics which were shown to significantly increase SI rates were; prednisone use, increasing age, chronic pulmonary comorbidity and specifically in those with rheumatoid arthritis male gender and total duration of bDMARD use.Conclusion:In this real-world NQ cohort of patients treated with a bDMARD for a rheumatic disease, we have identified a number of factors potentially contributing to the risk of the development of SIs. This study provides valuable data on SI rates in an Australian ‘real-world’ cohort that may assist clinicians’ choice of bDMARD in patients with a high baseline risk of infection and highlights the importance of minimising prednisone use in patients on bDMARDs.References:[1]Ramiro S, Sepriano A, Chatzidionysiou K, et al. Safety of synthetic and biological DMARDs: a systematic literature review informing the 2016 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis. 2017;76:1093–1101.[2]Singh J, Wells G, Christensen R, et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev. 2011;16:CD008794.Disclosure of Interests: :Kate Celkys: None declared, Jason Ly: None declared, Muriel Soden Speakers bureau: Speaker Fees from Pfizer in 2016

scholarly journals Long-term effectiveness in patients previously treated with cladribine tablets: a real-world analysis of the Italian multiple sclerosis registry (CLARINET-MS)

2020 ◽  
Vol 13 ◽  
pp. 175628642092268 ◽  
Author(s):  
Francesco Patti ◽  
Andrea Visconti ◽  
Antonio Capacchione ◽  
Sanjeev Roy ◽  
Maria Trojano ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Real World ◽  
Event Analysis ◽  
Treatment Change ◽  
Real World Data ◽  
Indirect Measure ◽  
Disease Modifying Drugs ◽  
Disease Modifying ◽  
Using Data

Background: The CLARINET-MS study assessed the long-term effectiveness of cladribine tablets by following patients with multiple sclerosis (MS) in Italy, using data from the Italian MS Registry. Methods: Real-world data (RWD) from Italian MS patients who participated in cladribine tablets randomised clinical trials (RCTs; CLARITY, CLARITY Extension, ONWARD or ORACLE-MS) across 17 MS centres were obtained from the Italian MS Registry. RWD were collected during a set observation period, spanning from the last dose of cladribine tablets during the RCT (defined as baseline) to the last visit date in the registry, treatment switch to other disease-modifying drugs, date of last Expanded Disability Status Scale recording or date of the last relapse (whichever occurred last). Time-to-event analysis was completed using the Kaplan–Meier (KM) method. Median duration and associated 95% confidence intervals (CI) were estimated from the model. Results: Time span under observation in the Italian MS Registry was 1–137 (median 80.3) months. In the total Italian patient population ( n = 80), the KM estimates for the probability of being relapse-free at 12, 36 and 60 months after the last dose of cladribine tablets were 84.8%, 66.2% and 57.2%, respectively. The corresponding probability of being progression-free at 60 months after the last dose was 63.7%. The KM estimate for the probability of not initiating another disease-modifying treatment at 60 months after the last dose of cladribine tablets was 28.1%, and the median time-to-treatment change was 32.1 (95% CI 15.5–39.5) months. Conclusion: CLARINET-MS provides an indirect measure of the long-term effectiveness of cladribine tablets. Over half of MS patients analysed did not relapse or experience disability progression during 60 months of follow-up from the last dose, suggesting that cladribine tablets remain effective in years 3 and 4 after short courses at the beginning of years 1 and 2.

scholarly journals FRI0651-HPR A RANDOMIZED PROSPECTIVE OPEN-LABEL CONTROLLED TRIAL COMPARING THE PERFORMANCE OF A CONNECTED MONITORING INTERFACE IN PATIENTS WITH RHEUMATOID ARTHRITIS VERSUS PHYSICAL ROUTINE MONITORING

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 929.1-930
Author(s):  
Y. M. Pers ◽  
V. Valsecchi ◽  
T. Mura ◽  
S. Aouinti ◽  
N. Filippi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Rheumatic Diseases ◽  
Tight Control ◽  
Link Type ◽  
Functional Scores ◽  
Monitoring Group ◽  
Disease Modifying

Background:Telemedicine has found wider application in chronic diseases for encouraging tight home-monitoring in order to improve patients’ outcome (Smolen et al. 2017).In previous studies, a high feasibility and high patient-satisfaction rate was found as well as the evidence for a superior or equal effectiveness of telemedicine compared to the standard face-to-face approach, however the results were weakened by some methodological biases and wide heterogeneity of interventions, thus preventing to draw definitive conclusions (Piga et al. 2017; Najm, Gossec, et al. 2019).Objectives:In rheumatoid arthritis (RA), telemedicine may allow a tight control of disease activity while reducing hospital visits. We developed a smartphone application connected with a physician’s interface to monitor RA patients. We aimed to assess the performance of this e-Health solution in comparison with routine practice in the management of patients with RA.Methods:A 6-month pragmatic, randomized, controlled, prospective, clinical trial was conducted in RA patients with high to moderate disease activity starting a new Disease Modifying Anti-Rheumatic Drug (DMARD) therapy. Two groups were established: “connected monitoring” and “conventional monitoring”. The primary outcome was the number of physical visits between baseline and 6 months. Secondary outcomes included adherence, satisfaction, changes in clinical, functional, and health status scores (SF-12).Results:Of the 94 randomized patients, 89 completed study: 44 in the “conventional monitoring” arm and 45 in the “connected monitoring” arm. The total number of physical visits between baseline and 6 month was significantly lower in the “connected monitoring” group (0.42 ± 0.58 versus 1.93 ± 0.55; p<0.05). No differences between groups were observed in the clinical and functional scores. A better quality of life for SF-12 subscores (Role-Physical, Social-Functioning and Role-Emotional) were found in the “connected monitoring” group.Conclusion:According to our results, a connected monitoring reduces the number of physical visits while maintaining a tight control of disease activity and improving quality of life in patients with RA starting a new treatment.References:[1] Najm, Aurelie, Laure Gossec, Catherine Weill, David Benoist, Francis Berenbaum, and Elena Nikiphorou. 2019. “Mobile Health Apps for Self-Management of Rheumatic and Musculoskeletal Diseases: Systematic Literature Review.”JMIR MHealth and UHealth7 (11): e14730.https://doi.org/10.2196/14730.[2] Piga, Matteo, Ignazio Cangemi, Alessandro Mathieu, and Alberto Cauli. 2017. “Telemedicine for Patients with Rheumatic Diseases: Systematic Review and Proposal for Research Agenda.”Seminars in Arthritis and Rheumatism47 (1): 121–28.https://doi.org/10.1016/j.semarthrit.2017.03.014.[3] Smolen, Josef S, Robert Landewe, Johannes Bijlsma, Gerd Burmester, Katerina Chatzidionysiou, Maxime Dougados, Jackie Nam, et al. 2017. “EULAR Recommendations for the Management of Rheumatoid Arthritis with Synthetic and Biological Disease-Modifying Antirheumatic Drugs: 2016 Update.”Annals of the Rheumatic Diseases76 (6): 960–77.https://doi.org/10.1136/annrheumdis-2016-210715.Disclosure of Interests:None declared

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