scholarly journals SAT0161 THE ANALGESIC EFFECT OF TOFACITINIB MAY HAVE CLINICAL SIGNIFICANCE IN PATIENTS WITH RHEUMATOID ARTHRITIS. DATA FROM THE MOSCOW UNIFIED REGISTER OF ARTHRITIS (MUAR)

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1021.2-1021
Author(s):  
E. Zhilyaev ◽  
G. Lukina ◽  
E. Koltsova ◽  
E. Shmidt ◽  
K. Lytkina
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Significance ◽  
Analgesic Effect ◽  
Activity Index ◽  
Theoretical Data ◽  
Disease Activity Index ◽  
Subjective Indicators ◽  
Ability Index ◽  
Subjective Estimates ◽  
Objective Indicators

Background:Some theoretical data suggest that the JAK-kinase blocker tofacitinib (TOFA) may have a direct analgesic effect.Objectives:to evaluate the clinical significance of the analgesic effect in patients with rheumatoid arthritis (RA) in real clinical practice.Methods:Hypothesis being tested: the analgesic effect of TOFA may be manifested by a decrease in the ratio of subjective to objective indicators of arthritis activity.Data from RA patients receiving biologics (bDMARD) and/or TOFA and included in the MUAR register were analyzed. The tender joints count (TJC), the HAQ-DI functional ability index, and the RAPID3 disease activity index were considered as subjective estimates. The swollen joints count (SJC) and the level of CRP were treated as objective indicators. The estimation of quotients from the division of subjective indicators into objective ones in all combinations is made.Taking into account the observational nature of the study, we searched for confounders for each of these ratios. Comparison of the calculated indices during the treatment with various targeted DMARDs (tDMARDs) was made with an adjustment for the detected confounders.Results:the analysis included 944 treatment episodes in 832 patients, including 93 episodes of TOFA treatment. The average age was 55.3 ± 12.4 years, women - 698 (83.9%), seropositive for RF -672 (80.8%). The analysis of the adjusted values showed that the ratios of the TJC, HAQ-DI and RAPID3 to the SJC during the treatment with TOFA was significantly lower than with tDMARDs on average. There were no significant differences in the ratios of objective indicators to the CRP level (Table).Table.Ratios of objective and subjective indicators during the treatment with tofacitinib and with tDMARDs therapy in generalConclusion:the severity of subjective feelings and functional disorders in RA patients receiving TOFA may be less with the same level of objective signs of arthritis compared with bDMARDs.Disclosure of Interests:Evgeniy Zhilyaev Speakers bureau: Novartis, UCB, Pfizer, Biocad, Abbvie, MSD, Roche, Galina Lukina Speakers bureau: Novartis, Pfizer, UCB, Abbvie, Biocad, MSD, Roche, Ekaterina Koltsova: None declared, Evgeniya Shmidt Speakers bureau: MSD, Novartis, Pfizer, Karine Lytkina Speakers bureau: Novartis, Eli Lilly, Pfizer, UCB, Abbvie, Biocad, MSD, Jonson&Jonson

scholarly journals Clinical significance of the direct analgesic effect of targeted medications in patients with rheumatoid arthritis

2020 ◽  
Vol 4 (8) ◽  
pp. 483-486
Author(s):  
E.V. Zhilyaev ◽  
◽  
G.V. Lukina ◽  
E.N. Koltsova ◽  
E.I. Shmidt ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Significance ◽  
Analgesic Effect ◽  
Genetically Engineered ◽  
Tender Joint Count ◽  
Confounding Factors ◽  
Subjective Indicators ◽  
Anti Inflammatory ◽  
Objective Indicators ◽  
Selection Of

Aim: to evaluate the possibility of clinically significant analgesic effect of tofacitinib in patients with rheumatoid arthritis (RA) under the conditions of actual clinical practice. Patients and Methods: data of patients with RA from the Moscow Unified Register of Arthritis (MERA) were analyzed. The subjective indica-tors included tender joint count (TJC), the HAQ (Health Assessment Questionnaire) Functional Capacity Index, the RAPID3 (Routine Assess-ment of Patient Index Data 3) Disease Activity Index. Swollen joint count (SJC) and the level of C-reactive protein (CRP) were analyzed as objective indicators of inflammatory activity. The estimation was conducted of the quotient obtained when subjective indicators were divided by objective indicators in all possible combinations for various targeted medications used in the studied group of patients. Given the observa-tional nature of the study, the search was carried out for confounding factors for all of these quotients. The calculated indices were compared during treatment with various targeted medications, adjusted for detected confounding factors. The process of selecting confounding factors was carried out in 2 stages — preliminary selection of indicators that have a significant one-factor association with the dependent variable, and subsequent reverse stepwise selection of variables within the framework of a generalized linear model.Results: the analysis included 944 episodes of treatment in 832 patients. The duration of episodes was 1312±1006 days. In particular, 93 epi-sodes of tofacitinib treatment were analyzed (average duration — 836±453 days). When the analysis was adjusted for the detected confound-ing factors, it was found that the indicators of TJC/(SJC+1), HAQ/(SJC+1) and RAPID3/(SJC+1) during tofacitinib therapy were significantly lower than the average values obtained with target medications. There were no significant differences between the medications in relation to the studied subjective indicators and the level of CRP.Conclusions: the severity of subjective perceptions and functional disorders in patients treated with tofacitinib may be less with the same severity of arthritis objective indicators compared to genetically engineered anti-inflammatory drugs.KEYWORDS: targeted medication, genetically engineered anti-inflammatory drug, tofacitinib, rheumatoid arthritis, real clinical practice.FOR CITATION: Zhilyaev E.V., Lukina G.V., Koltsova E.N. et al. Clinical significance of the direct analgesic effect of targeted medications in patients with rheumatoid arthritis. Russian Medical Review. 2020;4(8):483–486. DOI: 10.32364/2587-6821-2020-4-8-483-486.

scholarly journals Olokizumab, a monoclonal antibody against interleukin 6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by methotrexate: efficacy and safety results of a randomised controlled phase III study

2021 ◽  
pp. annrheumdis-2021-219876
Author(s):  
Evgeniy Nasonov ◽  
Saeed Fatenejad ◽  
Eugen Feist ◽  
Mariana Ivanova ◽  
Elena Korneva ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Phase Iii ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Acr20 Response

ObjectiveTo evaluate the efficacy and safety of olokizumab (OKZ) in patients with active rheumatoid arthritis despite treatment with methotrexate (MTX).MethodsIn this 24-week multicentre, placebo-controlled, double-blind study, patients were randomised 1:1:1 to receive subcutaneously administered OKZ 64 mg once every 2 weeks, OKZ 64 mg once every 4 weeks, or placebo plus MTX. The primary efficacy endpoint was the proportion of patients achieving an American College of Rheumatology 20% (ACR20) response at week 12. The secondary efficacy endpoints included percentage of subjects achieving Disease Activity Score 28-joint count based on C reactive protein <3.2, Health Assessment Questionnaire Disability Index at week 12, ACR50 response and Clinical Disease Activity Index ≤2.8 at week 24. Safety and immunogenicity were assessed throughout the study.ResultsA total of 428 patients were randomised. ACR20 responses were more frequent with OKZ every 2 weeks (63.6%) and OKZ every 4 weeks (70.4%) than placebo (25.9%) (p<0.0001 for both comparisons). There were significant differences in all secondary efficacy endpoints between OKZ-treated arms and placebo. Treatment-emergent serious adverse events (TESAEs) were reported by more patients in the OKZ groups compared with placebo. Infections were the most common TESAEs. No subjects developed neutralising antidrug antibodies.ConclusionsTreatment with OKZ was associated with significant improvement in signs, symptoms and physical function of rheumatoid arthritis without discernible differences between the two regimens. Safety was as expected for this class of agents. Low immunogenicity was observed.Trial registration numberNCT02760368.

Effect of Remission Definition on Healthcare Cost Savings Estimates for Patients with Rheumatoid Arthritis Treated with Biologic Therapies

2014 ◽  
Vol 41 (8) ◽  
pp. 1600-1606 ◽  
Author(s):  
Cheryl Barnabe ◽  
Nguyen Xuan Thanh ◽  
Arto Ohinmaa ◽  
Joanne Homik ◽  
Susan G. Barr ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Healthcare Cost ◽  
Activity Index ◽  
Cost Savings ◽  
Disease Activity Index ◽  
Disease Status ◽  
Point Estimate ◽  
Sustained Remission ◽  
American College Of Rheumatology

Objective.Sustained remission in rheumatoid arthritis (RA) results in healthcare utilization cost savings. We evaluated the variation in estimates of savings when different definitions of remission [2011 American College of Rheumatology/European League Against Rheumatism Boolean Definition, Simplified Disease Activity Index (SDAI) ≤ 3.3, Clinical Disease Activity Index (CDAI) ≤ 2.8, and Disease Activity Score-28 (DAS28) ≤ 2.6] are applied.Methods.The annual mean healthcare service utilization costs were estimated from provincial physician billing claims, outpatient visits, and hospitalizations, with linkage to clinical data from the Alberta Biologics Pharmacosurveillance Program (ABioPharm). Cost savings in patients who had a 1-year continuous period of remission were compared to those who did not, using 4 definitions of remission.Results.In 1086 patients, sustained remission rates were 16.1% for DAS28, 8.8% for Boolean, 5.5% for CDAI, and 4.2% for SDAI. The estimated mean annual healthcare cost savings per patient achieving remission (relative to not) were SDAI $1928 (95% CI 592, 3264), DAS28 $1676 (95% CI 987, 2365), and Boolean $1259 (95% CI 417, 2100). The annual savings by CDAI remission per patient were not significant at $423 (95% CI −1757, 2602). For patients in DAS28, Boolean, and SDAI remission, savings were seen both in costs directly related to RA and its comorbidities, and in costs for non-RA-related conditions.Conclusion.The magnitude of the healthcare cost savings varies according to the remission definition used in classifying patient disease status. The highest point estimate for cost savings was observed in patients attaining SDAI remission and the least with the CDAI; confidence intervals for these estimates do overlap. Future pharmacoeconomic analyses should employ all response definitions in assessing the influence of treatment.

scholarly journals Effectiveness of Rituximab for the Treatment of Rheumatoid Arthritis in Patients with Prior Exposure to Anti-TNF: Results from the CORRONA Registry

2015 ◽  
Vol 42 (7) ◽  
pp. 1090-1098 ◽  
Author(s):  
Leslie R. Harrold ◽  
George W. Reed ◽  
Ashwini Shewade ◽  
Robert Magner ◽  
Katherine C. Saunders ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Clinical Effectiveness ◽  
High Disease Activity ◽  
Low Disease Activity ◽  
Logistic Regression Models ◽  
Lower Baseline ◽  
Previously Treated

Objective.To characterize the real-world effectiveness of rituximab (RTX) in patients with rheumatoid arthritis.Methods.Clinical effectiveness at 12 months was assessed in patients who were prescribed RTX based on the Clinical Disease Activity Index (CDAI). Change in CDAI was calculated (CDAI at 12 mos minus at initiation). Achievement of remission or low disease activity (LDA; CDAI ≤ 10) among those with moderate/high disease activity at the time of RTX initiation was compared based on prior anti-tumor necrosis factor agent (anti-TNF) use (1 vs ≥ 2) using logistic regression models.Results.Patients (n = 265) were followed for 12 months with a mean change in CDAI of −8.1 (95% CI −9.8 – −6.4). Of the 218 patients with moderate/high disease activity at baseline, patients with 1 prior anti-TNF (baseline CDAI 25.0) demonstrated a mean change in CDAI of −10.1 (95% CI −13.2 – −7.0); patients with ≥ 2 prior anti-TNF (baseline CDAI 30.0) demonstrated a mean change of −10.5 (95% CI −12.9 – −8.0). The unadjusted OR for achieving LDA/remission in patients with moderate/high disease activity at baseline exposed to ≥ 2 versus 1 prior anti-TNF was 0.40 (95% CI 0.22–0.73), which was robust to 4 different adjusted models (OR range 0.38–0.44).Conclusion.A good clinical response was observed in all patients; however, patients previously treated with 1 anti-TNF, who had lower baseline CDAI and a greater opportunity for clinical improvement compared with patients previously treated with ≥ 2 anti-TNF, were more likely to achieve LDA/remission.

scholarly journals Rheumatoid arthritis disease activity index-5: Utility in busy clinical settings

2017 ◽  
Vol 12 (2) ◽  
pp. 72
Author(s):  
VikramSingh Tanwar ◽  
Harpreet Singh ◽  
Gagandeep Sukhija ◽  
Rekha Mathur ◽  
Parminder Kaur
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Clinical Settings ◽  
Rheumatoid Arthritis Disease Activity ◽  
Rheumatoid Arthritis Disease

scholarly journals Rate of hypovitaminosis D and association of plasma concentration of 25(OH)D with indicators of disease activity in patients with rheumatoid arthritis

2020 ◽  
Vol 64 (6) ◽  
pp. 723-729
Author(s):  
A. V. Rudenko ◽  
T. D. Tyabut ◽  
A. E. Buglova ◽  
G. A. Babak ◽  
P. M. Morozik ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Vitamin D ◽  
Disease Activity ◽  
Vitamin D Deficiency ◽  
Activity Index ◽  
Serum Vitamin ◽  
Disease Activity Index ◽  
Tender Joint Count ◽  
Serum Vitamin D ◽  
Vitamin D Levels

Vitamin D deficiency is an important environmental risk factor that influences the prevalence and severity of several autoimmune diseases, including rheumatoid arthritis (RA). The aim of this study was to determine the incidence of vitamin D insufficiency and deficiency in patients with RA, to establish the relationship between serum vitamin D levels and indicators of disease activity. 156 patients with RA were included in the study, mean age 60.2 ± 13.9 years. Assessment of clinical status was performed, serum concentrations of rheumatoid factor (RF), C-reactive protein (CRP), total vitamin D (25(OH)D), antibodies to cyclic citrullinated peptide (ACCP) were determined. RA disease activity was evaluated using DAS28 (disease activity score), SDAI (Simplified Disease Activity Index) и CDAI (Clinical Disease Activity Index) scores. Average levels of 25(OH)D in the surveyed sample were 25.2 ± 13.2 ng/ml. The results of the study indicate a high prevalence of vitamin D deficiency in patients with RA. Normal indicators of vitamin D, its insufficiency and deficiency were observed in 47 (30.3 %), 45 (28.7 %) and 64 (40.7 %) patients, respectively. Low level of serum 25(OH)D was associated with higher indices of RA activity according to DAS28, SDAI and CDAI, as well as with greater tender joint count. Vitamin D should be prescribed as an adjunctive therapy in patients with active RA due to its potential immunomodulatory effect, as well as for the prevention and treatment of bone metabolism disorders.

scholarly journals Reasons for discordances between ultrasonography and magnetic resonance imaging in the evaluation of the ankle, hindfoot and heel of the patients with rheumatoid arthritis

2019 ◽  
Vol 21 (4) ◽  
pp. 405 ◽  
Author(s):  
Oana Șerban ◽  
Daniela Fodor ◽  
Iulia Papp ◽  
Mihaela Cosmina Micu ◽  
Dan Gabriel Duma ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Disease Activity ◽  
Activity Index ◽  
Imaging Techniques ◽  
Disease Activity Index ◽  
Resonance Imaging ◽  
Magnetic Resonance Imaging Mri ◽  
Definition Of

Aim: To compare the ultrasonography (US) performance with magnetic resonance imaging (MRI) in identifying pathology in ankles, hindfeet and heels of rheumatoid arthritis (RA) patients and to evaluate the reasons for discordances between the two imaging methods.Material and methods: RA patients were enrolled and evaluated using the Clinical Disease Activity Index (CDAI) and the Disease Activity Score 28 with C-reactive Protein (DAS28-CRP). The ankle (tibiotalar joint, tendons), hindfoot (talonavicular, subtalar joints) and heel of the most symptomatic or dominant foot (for the asymptomatic patient)were evaluated by two pairs of examiners using US and contrast-enhanced MRI.Results: Totally, 105 joints, 245 tendons and 35 heels in 35 patients [mean age 59.2±11.25 years old, median disease duration 36 (16.5-114), mean CDAI 19.87±12.7] were evaluated. The interobserver agreements between the two sonographers, and the two radiologists were good and very good (k=0.624-0.940). The overall agreement between US and MRI was very good for subcalcaneal panniculitis (k=0.928, p<0.001), moderate for synovitis (k=0.463, p<0.001) and tenosynovitis (k=0.514, p<0.001), fair for osteophytes (k=0.260, p=0.004), and poor for erosions (k=0.063, p=0.308) and heel’s structures. MRI found more erosions, synovitis, osteophytes,tenosynovitis and retrocalcaneal bursitis, but US found more enthesophytes and plantar fasciitis. Many of the discordancesbetween the two imaging techniques have explanations related to the technique itself or definition of the pathologic findings.Conclusions: US is comparable to MRI for the evaluation of ankle, hindfoot and heel in RA patients and discordances in theinterpretation of the pathological findings/normal structures must be carefully analyzed.

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