Rheumatoid Arthritis, Treatment Adherence and Compliance
Conditions
Keywords
Rheumatoid Arthritis, tofacitinib, disease activity
Brief summary
The investigators aimed to present the efficacy and safety data for patients with RA who received tofacitinib therapy in outpatient clinics.
Detailed description
This retrospective cohort study included 35 patients with rheumatoid arthritis who received tofacitinib therapy in rheumatology outpatient clinic between June 2015 and December 2019. Patients who received tofacitinib due to unresponsiveness to ≥2 conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and/or ≥1 biological disease-modifying anti-rheumatic drugs (bDMARDs) were retrospectively evaluated. Demographic characteristics of the patients, the disease activity score-28 for rheumatoid arthritis with erythrocyte sedimentation rate (DAS 28-4 (ESR)), change in DAS-28, health assessment questionnaire score, visual analogue scale score, and laboratory parameters such as erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level, hemogram, lipid parameters, and uric acid were recorded. The data at six months of treatment were compared with baseline data. The effects related to the treatment as well as the undesired consequences were evaluated.
Interventions
None listed
Sponsors
Umraniye Education and Research Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
No
Inclusion criteria
Patients who received tofacitinib due to unresponsiveness to ≥2 csDMARDs and/or ≥1 bDMARDs were retrospectively evaluated. \-
Exclusion criteria
Patients who could not tolerate the treatment and whose follow-up results could not be reached were excluded from the study. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluates the effects of tofacitinib therapy by measuring change in DAS 28-4 (ESR) and improvement in DAS-28 | 6 months | Clinical and laboratory parameters (DAS 28-4 (ESR), improvement in DAS-28) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs. |
| Evaluates the effects of tofacitinib therapy by measuring change in health assessment questionnaire score, visual analogue scale score | 6 months | Clinical parameters (health assessment questionnaire score, visual analogue scale score) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs. |
| Evaluates the effects of tofacitinib therapy by measuring change in erythrocyte sedimentation rate (ESR) | 6 months | Laboratory parameters (erythrocyte sedimentation rate (ESR)) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs. |
| Evaluates the effects of tofacitinib therapy by measuring change C-reactive protein (CRP) level | 6 months | Laboratory parameters (C-reactive protein (CRP) level) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs. |
| Evaluates the effects of tofacitinib therapy by measuring change hemogram | 6 months | Laboratory parameters (hemogram) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs. |
| Evaluates the effects of tofacitinib therapy by measuring change lipid parameters | 6 months | Laboratory parameters (lipid parameters , Total Cholesterol; LDL, Low-Density Lipoprotein; HDL, High-Density Lipoprotein; TG, triglyceride) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs. |
| Evaluates the effects of tofacitinib therapy by measuring change uric asid | 6 months | Laboratory parameters (uric asid) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs. |
Outcome results
None listed