Psoriatic Arthritis
Conditions
Brief summary
Psoriatic arthritis (PsA) is an inflammatory arthritis with substantial variation in clinical features. We propose a multicenter collaborative approach to better understand the phenotypes and current management of PsA in the United States.The central goal of this proposal is to obtain the data necessary to design a pragmatic trial in PsA.
Detailed description
Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that can be associated with devastating outcomes including irreversible joint damage. The management of a patient with PsA is extremely challenging due to the high degree of phenotypic heterogeneity. The ultimate goal of this proposal is to prepare pragmatic trials in PsA trials that will encompass all relevant subgroups of patients. The aims of this study specifically focus on responses to biologic therapy among patients with PsA and determining the optimal set of outcome measures for PsA trials.
Interventions
None listed
Sponsors
The Cleveland Clinic
NYU Langone Health
University of Utah
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Inclusion criteria
* Age 18-89 * Active PsA (at least one swollen joint or enthesitis) -Meet CASPAR criteria (Table 2) (103) -Initiation of TNFi (etanercept, adalimumab, infliximab, certolizumab, golimumab) (At the time of the submission, TNFi biosimilars have been approved by the FDA but are not available on the US market. Once available, patients starting TNFi biosimilars will similarly be eligible for participation. Patients may have been on the medication in the past but must have had greater than 2 months off the medication.Patients may be taking other traditional DMARDs. A washout period is not required.)
Exclusion criteria
* Unable to give informed consent * Out of the age range * Switching therapies for skin psoriasis in the setting of well controlled joint and enthesis symptoms. * Patients with only active PsA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Function Response to Biologic Therapy as Measured by RAPID3 | 3 Months | Patient's perception of response to therapy as related to patient functionality. Measured by a change in RAPID3 score from baseline to 3 month visit. RAPID3 (Routine Assessment of Patient Index Data 3) is a pooled index of the 3 patient-reported American College of Rheumatology Core Data Set measures: function, pain, and patient global estimate of status. Each of the 3 individual measures is scored 0 to 10, for a total of 30. Disease severity may be classified on the basis of RAPID3 scores: \>12 = high; 6.1-12 = moderate; 3.1-6 = low; \< or =3 = remission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Quality of Life Response to Biologic Therapy as Measured by PROMIS10 | 3 Months | Patient's perception of response to therapy as related to quality of life. Measured by change in PROMIS10 Physical Health score from baseline to 3 month visit. PROMIS10 (Patient-Reported Outcomes Measurement Information System) Physical Health is a 10-item questionnaire, each with a five point scale from Poor to Excellent. PROMIS uses Item Response Theory (IRT) statistical model that links individual questions to a presumed underlying trait or concept of global health represented by all items in the scale; instruments are scored using item-level calibrations (response pattern scoring) in an online tool (T-Score range 0-100). Increasing score indicates improvement. |
| Patient Quality of Life Response to Biologic Therapy as Measured by PSAID | 3 Months | Patient's perception of response to therapy as related to quality of life. Measured by change in PSAID score from baseline to 3 month visit. PSAID (PsA Impact of Disease) is a questionnaire composed of 12 health domains, examining different perspectives (both physical and psychological). Each domain is evaluated by a single question with a range from 0-10 in which higher results indicate a greater impact of the disease. Individual domain scores are weighted to indicate those with a greater effect, then the sum of weighted domain scores is divided by 20 to compute the final score (range 0-10). |
| Physician Assessment of Disease Response to Biologic Therapy as Measured by Swollen Joint Count. | 3 Months | Physician assessment of disease activity as measured by change in swollen joint count from baseline to 3 months. |
| Patient Function Response to Biologic Therapy as Measured by HAQ-DI | 3 Months | Patient's perception of response to therapy as related to patient functionality. Measured by change in HAQ-DI score from baseline to 3 month visit. The HAQ-DI (Health Assessment Questionnaire - Disability Index) covers 20 items in eight domains related to measuring difficulty in performing activities of daily living. Each question is rated on a 0-3 scale, where 0 indicates without difficulty and 3 indicates unable to do. The highest score in each domain is accepted as the score in that domain. Scores for the 8 domains are averaged to compute final score between 0 and 3. Scores 0-1 indicate mild to moderate disability, 1-2 indicate moderate to severe disability, and 2-3 indicate severe to very severe disability. |
| Disease Activity and Response to Biologic Therapy as Measured by Patient Pain Assessment | 3 Months | Disease Activity and Response to Biologic Therapy as measured by change in Patient Pain Assessment from baseline to 3 month visit. The Patient Pain Assessment is measured on a scale of 0-100 where a higher score indicates worse pain. |
| Disease Activity and Response to Biologic Therapy as Measured by Physician Global Assessment | 3 Months | Disease Activity and Response to Biologic Therapy as measured by change in Physician Global Assessment from baseline to 3 month visit. Physician Global Assessment is measured on a scale from 0-10 where a higher score indicates greater disease impact. |
| Disease Activity and Response to Biologic Therapy as Measured by Patient Global Assessment | 3 Months | Disease Activity and Response to Biologic Therapy as measured by change in Patient Global Assessment from baseline to 3 month visit. Patient Global Assessment is measured on a scale of 0-10 where a higher score indicates greater disease impact. |
| Physician Assessment of Disease Response to Biologic Therapy as Measured by Tender Joint Count. | 3 Months | Physician assessment of disease activity as measured by change in tender joint count from baseline to 3 months. |
Countries
United States
Participant flow
Recruitment details
171 unique participants were enrolled in the study, but there were 266 instances of treatment initiation analyzed (each participant could initiate \>1 therapy). Of the 266 instances of treatment initiation, not all outcome measures were completed at both Baseline and Month 3. Therefore, some outcome measures have a smaller number of units analyzed to include only those completed at both timepoints.
Participants by arm
| Arm | Count |
|---|---|
| Observational Group This is an observational study with only one group/cohort with no intervention | 171 |
| Observational Group This is an observational study with only one group/cohort with no intervention | 266 |
| Total | 437 |
Baseline characteristics
| Characteristic | Observational Group |
|---|---|
| Age, Continuous | 51.0 years STANDARD_DEVIATION 13.8 |
| Body surface area (%) | 1.6 % STANDARD_DEVIATION 3.9 |
| Dactylitis count | 0.3 digits STANDARD_DEVIATION 1.2 |
| Enthesitis count | 0.6 entheses STANDARD_DEVIATION 1.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 treatment initiations |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 229 treatment initiations |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 17 treatment initiations |
| Race (NIH/OMB) American Indian or Alaska Native | 4 treatment initiations |
| Race (NIH/OMB) Asian | 1 treatment initiations |
| Race (NIH/OMB) Black or African American | 1 treatment initiations |
| Race (NIH/OMB) More than one race | 0 treatment initiations |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 treatment initiations |
| Race (NIH/OMB) Unknown or Not Reported | 18 treatment initiations |
| Race (NIH/OMB) White | 242 treatment initiations |
| Sex: Female, Male Female | 140 treatment initiations |
| Sex: Female, Male Male | 126 treatment initiations |
| Swollen joint count | 2.9 joints STANDARD_DEVIATION 4.9 |
| Tender joint count | 5.8 joints STANDARD_DEVIATION 7.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 171 |
| other Total, other adverse events | 0 / 171 |
| serious Total, serious adverse events | 0 / 171 |
Outcome results
Primary
Patient Function Response to Biologic Therapy as Measured by RAPID3
Patient's perception of response to therapy as related to patient functionality. Measured by a change in RAPID3 score from baseline to 3 month visit. RAPID3 (Routine Assessment of Patient Index Data 3) is a pooled index of the 3 patient-reported American College of Rheumatology Core Data Set measures: function, pain, and patient global estimate of status. Each of the 3 individual measures is scored 0 to 10, for a total of 30. Disease severity may be classified on the basis of RAPID3 scores: \>12 = high; 6.1-12 = moderate; 3.1-6 = low; \< or =3 = remission.
Time frame: 3 Months
Population: 225 completed RAPID3 at Baseline and Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observational Group | Patient Function Response to Biologic Therapy as Measured by RAPID3 | -1.11 change in score | Standard Deviation 5.26 |
Secondary
Disease Activity and Response to Biologic Therapy as Measured by Patient Global Assessment
Disease Activity and Response to Biologic Therapy as measured by change in Patient Global Assessment from baseline to 3 month visit. Patient Global Assessment is measured on a scale of 0-10 where a higher score indicates greater disease impact.
Time frame: 3 Months
Population: 234 instances of therapy initiation completed the Pt Global assessment at Baseline and Month 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observational Group | Disease Activity and Response to Biologic Therapy as Measured by Patient Global Assessment | -0.24 change in score | Standard Deviation 2.66 |
Secondary
Disease Activity and Response to Biologic Therapy as Measured by Patient Pain Assessment
Disease Activity and Response to Biologic Therapy as measured by change in Patient Pain Assessment from baseline to 3 month visit. The Patient Pain Assessment is measured on a scale of 0-100 where a higher score indicates worse pain.
Time frame: 3 Months
Population: 234 instances of therapy initiation completed the Pt Pain assessment at Baseline and Month 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observational Group | Disease Activity and Response to Biologic Therapy as Measured by Patient Pain Assessment | -0.75 change of score | Standard Deviation 2.66 |
Secondary
Disease Activity and Response to Biologic Therapy as Measured by Physician Global Assessment
Disease Activity and Response to Biologic Therapy as measured by change in Physician Global Assessment from baseline to 3 month visit. Physician Global Assessment is measured on a scale from 0-10 where a higher score indicates greater disease impact.
Time frame: 3 Months
Population: 249 instances of therapy initiation had a Physician Global Assessment at Baseline and Month 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observational Group | Disease Activity and Response to Biologic Therapy as Measured by Physician Global Assessment | -0.30 change in score | Standard Deviation 1.54 |
Secondary
Patient Function Response to Biologic Therapy as Measured by HAQ-DI
Patient's perception of response to therapy as related to patient functionality. Measured by change in HAQ-DI score from baseline to 3 month visit. The HAQ-DI (Health Assessment Questionnaire - Disability Index) covers 20 items in eight domains related to measuring difficulty in performing activities of daily living. Each question is rated on a 0-3 scale, where 0 indicates without difficulty and 3 indicates unable to do. The highest score in each domain is accepted as the score in that domain. Scores for the 8 domains are averaged to compute final score between 0 and 3. Scores 0-1 indicate mild to moderate disability, 1-2 indicate moderate to severe disability, and 2-3 indicate severe to very severe disability.
Time frame: 3 Months
Population: 85 participants completed HAQ-DI at Baseline and Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observational Group | Patient Function Response to Biologic Therapy as Measured by HAQ-DI | -0.07 change in score | Standard Deviation 0.42 |
Secondary
Patient Quality of Life Response to Biologic Therapy as Measured by PROMIS10
Patient's perception of response to therapy as related to quality of life. Measured by change in PROMIS10 Physical Health score from baseline to 3 month visit. PROMIS10 (Patient-Reported Outcomes Measurement Information System) Physical Health is a 10-item questionnaire, each with a five point scale from Poor to Excellent. PROMIS uses Item Response Theory (IRT) statistical model that links individual questions to a presumed underlying trait or concept of global health represented by all items in the scale; instruments are scored using item-level calibrations (response pattern scoring) in an online tool (T-Score range 0-100). Increasing score indicates improvement.
Time frame: 3 Months
Population: 183 instances of therapy initiation completed PROMIS10 PH at Baseline and Month 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observational Group | Patient Quality of Life Response to Biologic Therapy as Measured by PROMIS10 | 1.43 change in score | Standard Deviation 6.2 |
Secondary
Patient Quality of Life Response to Biologic Therapy as Measured by PSAID
Patient's perception of response to therapy as related to quality of life. Measured by change in PSAID score from baseline to 3 month visit. PSAID (PsA Impact of Disease) is a questionnaire composed of 12 health domains, examining different perspectives (both physical and psychological). Each domain is evaluated by a single question with a range from 0-10 in which higher results indicate a greater impact of the disease. Individual domain scores are weighted to indicate those with a greater effect, then the sum of weighted domain scores is divided by 20 to compute the final score (range 0-10).
Time frame: 3 Months
Population: 225 instances of therapy initiation completed PSAID at Baseline and Month 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observational Group | Patient Quality of Life Response to Biologic Therapy as Measured by PSAID | -0.30 change in score | Standard Deviation 1.05 |
Secondary
Physician Assessment of Disease Response to Biologic Therapy as Measured by Swollen Joint Count.
Physician assessment of disease activity as measured by change in swollen joint count from baseline to 3 months.
Time frame: 3 Months
Population: 256 instances of therapy initiation had swollen joint count measured at Baseline and Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observational Group | Physician Assessment of Disease Response to Biologic Therapy as Measured by Swollen Joint Count. | -0.81 change in joint count | Standard Deviation 4.71 |
Secondary
Physician Assessment of Disease Response to Biologic Therapy as Measured by Tender Joint Count.
Physician assessment of disease activity as measured by change in tender joint count from baseline to 3 months.
Time frame: 3 Months
Population: 256 instances of therapy initiation had tender joint count measured at Baseline and Month 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observational Group | Physician Assessment of Disease Response to Biologic Therapy as Measured by Tender Joint Count. | -0.63 change in joint count | Standard Deviation 8.35 |