Rheumatoid Arthritis
Conditions
Brief summary
Identify the burden of comorbidity at the time of diagnosis of rheumatoid arthritis. Identify the impact of comorbidity present at diagnosis on cardiovascular disease, death, rheumatoid arthritis disease progression and infections.
Interventions
Usual care
Sponsors
Momentum Data
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of rheumatoid arthritis prior to 1st January 2017 * Aged ≥18 years old
Exclusion criteria
* Patients with another other rheumatic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event Rate for a Cardiovascular Composite of Incident Myocardial Infarction, Stroke, or Heart Failure | From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of myocardial infarction, stroke, or heart failure (whichever came first) or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years). | — |
| Event Rate for a Composite of Incident Infections. | From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of infection or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years). | The composite will comprise incident upper respiratory tract infections, bronchitis, influenza-like illnesses, pneumonia, intestinal infectious diseases, herpes simplex, skin and soft tissue infections, urinary tract infections, and genital and perineal infections |
Secondary
| Measure | Time frame |
|---|---|
| Event Rate for Incident Stroke | From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of stroke or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years). |
| Event Rate for Incident Heart Failure | From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of heart failure or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years). |
| Event Rate for a Joint Operations Composite, Comprised of Incident Joint Operations on Shoulder, Elbow, Wrist, Hand, Hip, Knee, Ankle and Foot | From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of joint operation to follow-up or until 1st January 2017 (maximum follow-up: 13 years). |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rheumatoid Arthritis Cases New onset cases of rheumatoid arthritis
No specific intervention: Usual care | 6,591 |
| Controls Age, gender and primary care practice-matched controls
No specific intervention: Usual care | 6,591 |
| Total | 13,182 |
Baseline characteristics
| Characteristic | Controls | Total | Rheumatoid Arthritis Cases |
|---|---|---|---|
| Age, Continuous | 59.8 years STANDARD_DEVIATION 15.8 | 59.8 years STANDARD_DEVIATION 15.8 | 59.8 years STANDARD_DEVIATION 15.8 |
| Race/Ethnicity, Customized Asian | 174 Participants | 429 Participants | 255 Participants |
| Race/Ethnicity, Customized Black | 125 Participants | 253 Participants | 128 Participants |
| Race/Ethnicity, Customized Missing | 1819 Participants | 3082 Participants | 1263 Participants |
| Race/Ethnicity, Customized Mixed | 24 Participants | 50 Participants | 26 Participants |
| Race/Ethnicity, Customized Other | 21 Participants | 57 Participants | 36 Participants |
| Race/Ethnicity, Customized White | 4428 Participants | 9311 Participants | 4883 Participants |
| Region of Enrollment United Kingdom | 6591 participants | 13182 participants | 6591 participants |
| Sex: Female, Male Female | 4449 Participants | 8898 Participants | 4449 Participants |
| Sex: Female, Male Male | 2142 Participants | 4284 Participants | 2142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6,591 | 0 / 6,591 |
| other Total, other adverse events | 0 / 6,591 | 0 / 6,591 |
| serious Total, serious adverse events | 0 / 6,591 | 0 / 6,591 |
Outcome results
Primary
Event Rate for a Cardiovascular Composite of Incident Myocardial Infarction, Stroke, or Heart Failure
Time frame: From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of myocardial infarction, stroke, or heart failure (whichever came first) or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rheumatoid Arthritis Cases | Event Rate for a Cardiovascular Composite of Incident Myocardial Infarction, Stroke, or Heart Failure | 10.62 Events per 1000 person years |
| Controls | Event Rate for a Cardiovascular Composite of Incident Myocardial Infarction, Stroke, or Heart Failure | 8.13 Events per 1000 person years |
Primary
Event Rate for a Composite of Incident Infections.
The composite will comprise incident upper respiratory tract infections, bronchitis, influenza-like illnesses, pneumonia, intestinal infectious diseases, herpes simplex, skin and soft tissue infections, urinary tract infections, and genital and perineal infections
Time frame: From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of infection or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).
Population: This outcome was not assessed in controls
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rheumatoid Arthritis Cases | Event Rate for a Composite of Incident Infections. | 3506 Participants |
| Controls | Event Rate for a Composite of Incident Infections. | 0 Participants |
Secondary
Event Rate for a Joint Operations Composite, Comprised of Incident Joint Operations on Shoulder, Elbow, Wrist, Hand, Hip, Knee, Ankle and Foot
Time frame: From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of joint operation to follow-up or until 1st January 2017 (maximum follow-up: 13 years).
Population: A comparison with controls was not included for this endpoint as this end point was only relevant to people with rheumatoid arthritis (as a marker of disease severity) and was not collected for controls.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rheumatoid Arthritis Cases | Event Rate for a Joint Operations Composite, Comprised of Incident Joint Operations on Shoulder, Elbow, Wrist, Hand, Hip, Knee, Ankle and Foot | 20.11 Events per 1000 person years |
Secondary
Event Rate for Incident Heart Failure
Time frame: From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of heart failure or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rheumatoid Arthritis Cases | Event Rate for Incident Heart Failure | 3.98 Events per 1000 person years |
| Controls | Event Rate for Incident Heart Failure | 2.72 Events per 1000 person years |
Secondary
Event Rate for Incident Stroke
Time frame: From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of stroke or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rheumatoid Arthritis Cases | Event Rate for Incident Stroke | 4.29 Events per 1000 person years |
| Controls | Event Rate for Incident Stroke | 3.82 Events per 1000 person years |