Routine Assessment Of Patient Index Data Research Articles

Cotreatment with methotrexate in routine care patients with rheumatoid arthritis receiving biological treatment yields better outcomes over time

ObjectivesWe aimed to evaluate the effects of methotrexate (MTX) comedication added to biological disease-modifying antirheumatic drugs (bDMARD) on disease activity measures in patients with rheumatoid arthritis (RA) in routine care.MethodsPatients...

Minimal Clinically Important Improvement of Routine Assessment of Patient Index Data 3 in Rheumatoid Arthritis.

To estimate minimal clinically important improvement (MCII) of RAPID-3 (Routine Assessment of Patient Index Data 3) in rheumatoid arthritis (RA). RAPID-3 was computed before and after treatment escalation in a prospective study of adults with active RA. Patient judgment of improvement was used as the standard for a receiver-operating characteristic curve, from which MCII was estimated. Mean RAPID-3 improved from 16.3 to 11.1 between visits. MCII was -3.8 based on simultaneously optimized sensitivity and specificity, -3.5 using the 0.80 specificity criterion, and -4.1 using the Youden index. RAPID-3 improvement of 3.8/30 units appears clinically meaningful.

Technology-enabled specialty pharmacy utilization of the routine assessment of patient index data 3 (RAPID3) to monitor and enhance outcomes of rheumatoid arthritis (RA) patients – a retrospective review

Background: Rheumatoid arthritis is a chronic progressive autoimmune disease affecting 1.5 million people in the United States. Uncontrolled disease can lead to irreversible joint damage, deformity, and disability. Current practice guidelines by the American College of Rheumatology (ACR) recommend frequent monitoring of disease activity and treatment to a goal of remission or low severity. However, clinicians’ adherence to this treatment strategy is low. With monthly patient contact, specialty pharmacies are well positioned to facilitate patient outcomes tracking. The RAPID3 is a validated quality measure instrument endorsed by the ACR to monitor patient disease activity. TherigySTM is a therapy management software utilized by pharmacies to deliver and document specialty therapy management. The availability of RAPID3 implemented in TherigySTM® demonstrates the opportunity for pharmacies to optimize patient care.Objectives: To observe the potential of technology-enabled delivery and utilization of RAPID3 to RA patients by specialty pharmacies to augment patient care and better comply with guidelines.Methods:• TherigySTM® generated RAPID3 initial and auto-triggered follow-up assessments based on the previous score per guideline recommendations.• TherigySTM® prompted engagement of patients by pharmacists to conduct RAPID3 surveys.• Captured aggregated data for 944 unique patients managed between 12/1/17 and 8/5/18 by selected specialty pharmacies using TherigySTM® with more than 50 completed RAPID3 assessments.• RAPID3 score calculated to non-simplified scale of 0–30. • Potential trends and metrics were identified with data captured.Results: 85% of follow-up RAPID3 assessments scheduled via TherigySTM® were completed on time. Initial RA disease activity assessments were able to be stratified: 47% high, 28% moderate, 15% low and 10% Remission. Ongoing disease activity changes were trackable and monitored by pharmacists over the course of therapy (55% of observed patients had no change, 31% improved and 14% worsened). 265 patients with moderate to high disease activity completed follow-up RAPID3 assessments. The average patient received 1–2 follow-up assessments during the observation period.Conclusions: Technology-enabled clinical support has the potential to improve compliance with practice guidelines. Pharmacies using validated instruments such as the RAPID3 delivered via TherigySTM® can expand their role in monitoring and enhancing outcomes. In a multi-disciplinary setting, pharmacy can efficiently share outcomes data with providers and make appropriate recommendations.

Routine Assessment of Patient Index Data 3 Score and Psoriasis Quality of Life Assess Complementary Yet Different Aspects of Patient-Reported Outcomes in Psoriasis and Psoriatic Arthritis.

Psoriasis Quality of Life (PQoL-12) is a validated composite tool assessing patients' quality of life (QoL) with psoriasis (PsO) and psoriatic arthritis (PsA). Routine Assessment of Patient Index Data 3 (RAPID3), measuring physical function, pain, and patient global assessment, is used for rheumatoid arthritis. Routine Assessment of Patient Index Data 3 has not been used to assess PsO/PsA patients' QoL. The aim of this study was to investigate the correlation between PQoL-12 and RAPID3 in PsO and PsA patients in a cross-sectional and longitudinal analyses. Data came from PsO and PsA patients seen from 2008 to 2015 at Oregon Health & Science University (n = 558: 393 with PsO and 165 with PsA). Nonlinear least squares regressions modeled PQoL-12 with functions of RAPID3, controlling for time since first visit. Nonparametric ROC determined RAPID3 scores best correlating with PQoL-12 cutoffs. Among the PsO cohort, PQoL-12 was explained by RAPID3, the square of RAPID3, time since first visit, and the square of time since first visit; adjusted R = 0.414. For the PsA cohort, PQoL-12 was explained by RAPID3, change in slope of RAPID3 at 2.28, time since first visit, the square of time since first visit; adjusted R = 0.340. Routine Assessment of Patient Index Data 3 cutoffs for PQoL-12 scores of 48 and 96 (mild and moderate QoL impairment) in PsO were 1.55 and 5.72 and in PsA were 1.89 and 6.34. Routine Assessment of Patient Index Data 3 weakly correlated with PQoL-12, indicating these indices assess different aspects of PsO and PsA. Routine Assessment of Patient Index Data 3 fails to capture mental health information that greatly impacts patients' QoL, whereas PQoL-12 fails to capture the physical and functional aspects of the disease. Results indicate the importance of capturing mental health assessment in order to create a comprehensive tool to measure how psoriatic disease affects patients' QoL.

Evaluation of disease activity in patients with rheumatoid arthritis treated with tofacitinib by RAPID3: post hoc analyses from two phase 3 trials

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. We evaluated the relationship between disease activity, according to Routine Assessment of Patient Index Data 3 (RAPID3) after 6-month treatment with tofacitinib, and long-term outcomes at 24 months. This was a post hoc analysis of two 24-month, phase 3, randomized controlled trials in methotrexate (MTX)-naïve (ORAL Start [NCT01039688]) or MTX-inadequate responder patients (ORAL Scan [NCT00847613]) receiving tofacitinib 5 or 10 mg twice daily (BID) as monotherapy or with background MTX. RAPID3 scores were calculated at baseline, month (M)6, and M24, and defined as remission (≤ 3), low (LDA; > 3–≤ 6), moderate (MDA; > 6–≤ 12), or high disease activity (HDA; > 12). Clinical Disease Activity Index (CDAI), Health Assessment Questionnaire-Disability Index (HAQ-DI) scores, and radiographic non-progression (modified Total Sharp Scores ≤ 0) at M24 were evaluated by M6 RAPID3 response. Among patients receiving tofacitinib 5 or 10 mg BID, respectively, 42.2 and 51.5% (ORAL Start) and 29.8 and 39.0% (ORAL Scan) achieved RAPID3 remission/LDA at M6. Most patients maintained/improved RAPID3 responses at M24. A higher proportion of patients in RAPID3 remission/LDA versus MDA/HDA at M6 achieved CDAI remission, reported normative HAQ-DI scores (< 0.5), and achieved both normative HAQ-DI scores and radiographic non-progression at M24. Patients achieving RAPID3 remission/LDA after 6-month treatment with tofacitinib 5 or 10 mg BID have improved long-term outcomes versus patients with MDA/HDA. These findings support the use of RAPID3 to monitor longer-term disease activity in conjunction with physician-assessed measures.

Psychometric properties of MDHAQ/RAPID3 in patients with systemic lupus erythematosus.

The Multidimensional Health Assessment Questionnaire (MDHAQ) is a patient-reported outcome (PRO) tool that includes the Routine Assessment of Patient Index Data 3 (RAPID3), an index that can be calculated at the point of care. The objective of this study was to perform psychometric analyses of MDHAQ/RAPID3 to study its measurement properties in systemic lupus erythematosus (SLE). The MDHAQ was completed by 161 SLE patients in routine care, along with LupusPRO (a disease-specific PRO). The SLE disease-specific activity index (SELENA-SLEDAI) and damage (SDI) were assessed. Data from 70 patients with rheumatoid arthritis who had completed MDHAQ during their routine medical care were used as controls to compare the results of Physical Function (FN) domain exploratory factor analysis. Internal consistency reliability (ICR) for FN items was calculated using Cronbach's α. Validity of MDHAQ/RAPID3 was evaluated for content validity and construct validity. Responsiveness of the RAPID3 to changes in disease activity anchors was assessed. The ICR of the 10 physical function items on Cronbach's α was 0.88. Exploratory factor analysis revealed cross-loadings of three FN items. RAPID3 showed a strong correlation with LupusPRO health-related quality of life score (rho -0.68 (p < 0.001)), indicating convergent validity. RAPID3 scores did not correlate with disease activity indices or SDI. After adjustment for fibromyalgia status, a weak correlation with the Physician's Global Assessment (PGA) (rho = 0.31, p = 0.008) was noted. RAPID3 could differentiate between SLE patients based on flare status. RAPID3 was not responsive to changes in PGA, SELENA-SLEDAI or SELENA-Flare Index. MDHAQ/RAPID3 has fair reliability and validity in SLE.

Association of Oral-Health Related Quality of Life and General Health Assessment in Patients with Rheumatoid Arthritis.

To determine the impact of oral health related quality of life (OHRQoL) on general health in patients suffering from rheumatoid arthritis (RA). Ninety-one patients with RA (mean age 52.82 ± 11 years, 75.82% female, 20.87% smokers) and 30 systemically healthy patients (control) were evaluated for their OHRQoL by means of the Geriatric Oral Health Assessment Index (GOHAI) and the Oral Health Impact Profile (OHIP)-14 questionnaires. Self-perceived RA status was assessed using the Routine Assessment of Patient Index Data 3 (RAPID3). The mean SC-GOHAI score was 3.69 ± 2.47 for RA subjects and 1.36 ± 2.69 in the control group. Statistically significant differences were seen between RA and control groups (p < 0.05). RA patients with and without periodontitis (PA) exhibited similar SC-GOHAI (Simple Count GOHAI) scores (p = 0.980). No statistically significant differences were observed between any of the groups, either for the OHIP 14-extent or for the OHIP 14-prevalence. RAPID3 scores showed that the majority of the RA patients (65.93%) had high disease severity (RAPID3 >12, mean RAPID3 score 14.39 ± 5.14). Statistically significantly higher values were recorded for general health assessment (PTGE, p = 0.009) and fatigue (FT, p = 0.004) in RA with PA as compared to those without. SC-GOHAI with values between 5 and 8 was statistically significantly associated with high severity health impairment (RAPID3 >12, p = 0.014, OR: 8.64). Within their limits, the present findings indicate that: a) moderate OHRQoL as assessed by GOHAI may contribute to high severity impairment of health in RA patients, and b) the GOHAI questionnaire may represent a more adequate tool than OHIP-14 for assessing OHRQoL in patients suffering from RA.

Dickkopf 1 protein circulating levels as a possible biomarker of functional disability and chronic damage in patients with rheumatoid arthritis.

Rheumatoid arthritis (RA) is an inflammatory disease characterized by joint destruction, deformity, lower functionality, and decrease in life expectancy. Wingless signaling pathway (Wnt) has been recently involved in bone homeostasis. Studies suggest that overexpression of the pathway inhibitors, like the Dickkopf 1 protein (DKK1), has been implicated in bone destruction. The objective of this study is to compare circulating levels of DKK1 in different groups of patients with disease activity (remission, low, moderate, high activity,) and functionality status. Three hundred seventy-nine patients with RA were evaluated between March 2015 and November 2016. Disease activity was evaluated by disease activity score 28 with C-reactive protein (DAS28CPR), simplified and clinical disease activity scores (SDAI, CDAI), routine assessment of patient index data 3 (RAPID3), functional status using Multidimensional Health Assessment Questionnaire (MD-HAQ), and the Steinbrocker functional classification. DKK1 levels were measured by ELISA. The mean age was 60.7± 13.9years. Disease duration was 13.2± 10.9years. Higher levels of DKK1 were not associated with disease activity by CDAI (p = 0.70), SDAI (p = 0.84), DAS28CRP (p = 0.80), or RAPID3 (p = 0.70). Interestingly higher levels of DKK1 were significantly associated to lower functional status evaluating by the Steinbrocker classification (p = 0,013), severe disability by MD-HAQ (p = 0,004), and variables associated with joint destruction like osteoporosis, higher titles of rheumatoid factor, smoking, and increased hospital admissions related to RA. Higher levels of DKK1 were found in patients with lower functional status. This association was not found in patients with greater disease activity by CDAI, SDAI, DAS28, and RAPID3. This could be explained by more structural damage; DKK1 could be used as a biomarker of joint destruction in RA.

Comparison of composite indices with global synovitis score on ultrasound for detecting remission.

We aimed to compare composite indices with Ultrasound Global Synovitis Score (GLOESS) for remission in rheumatoid arthritis (RA). RA patients in remission according to the clinician were investigated with Disease Activity Score28 (DAS28), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), and RAPID-3 (Routine Assessment of Patient Index Data 3). Ultrasonography was performed using the GLOESS scores. Patients in CDAI-remission had lower GLOESS (median (IQR), 5(3-9.75) vs 7(4-11.75), p = 0.048) with a similar trend in SDAI (5(3-9.25) vs 7(4-11.25), p= 0.064). This was not observed with DAS28-CRP and RAPID3. Our results show that CDAI is superior to other indices to assess remission in RA.

Pivotal factors for successful withdrawal of nonsteroidal anti-inflammatory drugs in rheumatoid arthritis patients in remission or with low-disease activity.

The purpose of this study is to examine the patient-reported outcomes (PRO) after discontinuing nonsteroidal anti-inflammatory drugs (NSAIDs) and clinical factors associated with a favorable outcome in patients with rheumatoid arthritis (RA) in remission or with low-disease activity (LDA). A 16-week prospective open-label trial was conducted at eight rheumatology clinics in Korea. RA patients with 28-joint disease activity score based on erythrocyte sedimentation rate (DAS28-ESR) <3.2 who were on NSAIDs for more than a month were enrolled, and NSAIDs were discontinued. Acetaminophen (AAP) was used as the rescue medication, and NSAIDs were restarted when joint pain was intolerable with AAP. The endpoint was to analyze the group of patients who continued to withdraw NSAIDs. Among 109 enrolled patients, 105 completed the 16-week follow-up. Eighty-nine (84.8%) patients remained without restarting NSAIDs. In these patients, there was a slight increase in their pain levels compared with baseline (median 14.0 versus 19.0 using the pain-visual analog scale, p=0.010). However, changes in DAS28-ESR (p=0.638) and routine assessment of patient index data 3 (RAPID-3) (p=0.128) were insignificant. Moreover, 66 (62.9%) patients showed sustained effectiveness on PRO without restarting NSAIDs. In the multivariate regression models, joint swelling was the detrimental factor in NSAID withdrawal (odds ratio [OR] 0.149, 95% confidence interval [CI] 0.033-0.680, p=0.014) and sustained effectiveness (OR 0.284, 95% CI 0.091-0.883, p=0.030). Joint pain in RA patients in remission or with LDA can be well managed without NSAIDs, especially in those without swollen joints at the time of cessation.

A somatization comorbidity phenotype impacts response to therapy in rheumatoid arthritis: post-hoc results from the certolizumab pegol phase 4 PREDICT trial

BackgroundComorbidities may contribute to disease activity and treatment response in rheumatoid arthritis (RA) patients. We defined a somatization comorbidity phenotype (SCP) and examined its influence on response to certolizumab pegol (CZP) using data from the PREDICT trial.MethodsPatients in PREDICT were randomized to the patient-reported Routine Assessment of Patient Index Data 3 (RAPID3) or physician-based Clinical Disease Activity Index (CDAI) for treatment response assessment. Post-hoc analyses identified patients with the SCP, which included diagnosis of depression, fibromyalgia/myalgias, and/or use of medications indicated for treatment of depression, anxiety, or neuropathic pain. The effect of the SCP on RAPID3 or CDAI response at week 12 and low disease activity (LDA; Disease Activity Score in 28 joints based on erythrocyte sedimentation rate ≤ 3.2) at week 52, in week-12 responders, was analyzed using non-parametric analysis of covariance (ANCOVA).ResultsAt baseline, 43% (313/733) of patients met the SCP classification. Patients with the SCP were 9% more likely to withdraw from the trial. American College of Rheumatology 20% (ACR20), ACR50, and ACR70 responses were 5–14% lower among those with the SCP, and 11% more patients reported adverse events (AEs). Patients without SCP in the CDAI arm were twice as likely to achieve LDA at week 52 compared with those with SCP (32% versus 16%). No differentiation by SCP was observed in the RAPID3 arm (pooled result 21.5%).ConclusionsWe operationalized a potentially important somatization comorbidity phenotype in a trial setting that was associated with a substantially lower likelihood of treatment response and a higher frequency of AEs. Including large numbers of patients with this phenotype in RA trials may reduce the measured clinical effectiveness of a new molecule.Trial registrationClinicalTrials.gov, NCT01255761. Registered on 6 December 2010.

RAPID3 scores and hand outcome measurements in RA patients: a preliminary study.

The Routine Assessment of Patient Index Data 3 (RAPID3) is a patient-reported disease activity measure used to assess physical function, pain, and global health in patients with rheumatoid arthritis (RA) without formal joint counts. Since hand involvement and its decreased function are hallmarks of RA, the aim of our study was to investigate the performance of RAPID3 scores with regard to hand function and to confirm previous findings that the RAPID3 score as a disease activity measure is strongly correlated with the DAS28 score. Sixty-eight consecutive patients with RA (85% female), aged 18-75years, were included in the study and were recruited during their outpatient visit. Apart from demographic and clinical data, the obtained parameters of interest included RAPID3 scores and assessments of the function of the hand, namely, the signal of functional impairment (SOFI)-hand, grip strength, and pulp-to-palm distance, as well the Health Assessment Questionnaire- Disability Index (HAQ-DI) and DAS28 scores. Pearson's correlation coefficient, Student's t test and linear regression were used in the statistical analysis of the results. The significance was set to p<0.05. A positive correlation was found between RAPID3 scores and HAQ-DI scores, SOFI-hand scores, and pulp-to-palm distance, and negative correlation was observed between RAPID3 scores and grip strength. The order regarding the strength of correlations between RAPID3 scores and other variables (from the strongest to the weakest) was as follows: HAQ-DI, grip strength, SOFI-hand and pulp-to-palm distance. The hand assessment variables had stronger correlations with RAPID3 scores than with DAS28 scores. Our preliminary study showed that RAPID3 scores were strongly correlated with measurements of the functional ability of the hand, demonstrating that RAPID3 can be used as a measure of disease activity in clinical practice and to characterize hand function. Further studies are needed to confirm this result.

Correlation between rapid-3, DAS28, CDAI and SDAI as a measure of disease activity in a cohort of Colombian patients with rheumatoid arthritis.

The objective of this study is to correlate the patient-driven tool Routine Assessment of Patient Index Data 3 (RAPID-3) with other common tools used in daily practice to measure disease activity in rheumatoid arthritis (RA).One hundred nineteen RA patients according to 1987 American College of Rheumatology criteria who consecutively attended a RA outpatient clinic between August and December 2015 were evaluated. Data was stored in an electronic form that included demographic information, comorbidities, concomitant medication, and laboratory results. The disease activity was determined by tender and swollen joint count, pain and disease activity visual analog scales (VAS), disease activity score 28 (DAS28), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), and multidimensional health assessment questionnaire (MDHAQ). Correlations between RAPID-3 and other disease activity tools were assessed. Mean age was 61±13.8years with a median disease duration of 14years (IQR 5-21), 77% were females. Median scores were MDHAQ 0.5 (IQR 0.1-1.2), DAS 28 3.8 (IQR 2.7-5.1), and RAPID-3 12.3 (IQR 6-19). A strong correlation was obtained between RAPID-3 and DAS 28 (r 0.719, p<0.001), CDAI (r 0.752, p<0.001), and SDAI (r 0.758, p<0.001). RAPID-3 had a high correlation with tools regularly used for disease activity assessment of RA patients in daily practice. The ease of its application favors routine use as it does not require laboratory results and joint counts.

The QuickDASH in the Assessment of Rheumatoid Arthritis Disease Activity

Introduction: Rheumatoid Arthritis (RA) is a chronic inflammatory arthritis associated with substantial morbidity and mortality. Disease activity indices help guide therapy towards disease remission. This study studied whether the modified version of the Disabilities of Arm, Shoulder, and Hand (DASH), the QuickDASH, was valid in measuring RA disease activity. Methods: This prospective cohort study evaluated the performance of the QuickDASH in measuring RA disease activity as compared with the validated index, the Routine Assessment of Patient Index Data 3 (RAPID3). Both questionnaires were completed by subjects at each clinic visit. Primary endpoint was assessment of construct validity and reliability of the QuickDASH in the assessment of RA disease activity as compared to the RAPID3. Results: One-hundred and five patients enrolled in this study. There is a strong correlation between QuickDASH and RAPID3 (r=0.808, p&lt;0.0001). The high reliability of the QuickDASH was indicated with an intraclass correlation coefficient (ICC) of 0.882 (95% CI: 0.864, 0.899) (p&lt;0.0001). Internal consistency was strong (Cronbach alpha 0.894). Linear regression analysis yielded QuickDASH=3.595+(2.789*RAPID3). Reliability of the QuickDASH in capturing disease activity consistent with RAPID3 ranges was high with an ICC of 0.858 (95% CI 0.835, 0.877) (p&lt;0.0001). Conclusion: This study demonstrated that the QuickDASH was very reliable and internally consistent in the measurement of RA disease activity. The QuickDASH correlates well with ranges of RA disease activity established by the RAPID3 and may be a surrogate for the RAPID3 in clinical practice.

Toward Electronic Health Recording: Evaluation of Electronic Patient-reported Outcome Measures System for Remote Monitoring of Early Rheumatoid Arthritis.

To assess the use of electronic patient-reported outcome measures (ePROM) in standard clinical practice for early rheumatoid arthritis (RA) management, the ePROM ability to enhance clinical care, and how computing technology can improve the patients' adherence to therapy. In a double-blinded randomized-controlled study, 211 patients with early RA diagnosed according to American College of Rheumatology/European League Against Rheumatism criteria completed a PROM in paper format at their first clinic visit. Patients were then randomized to Group 1, which completed an ePROM questionnaire monthly, or Group 2, which continued the standard paper PROM format. Over a 12-month period, Group 1 patients were assessed every 3 months in the clinic, whereas Group 2 patients were assessed in the clinic initially monthly for 6 months, then every 3 months. The primary endpoint was the equivalence of outcomes [Routine Assessment of Patient Index Data 3 (RAPID-3) and 28-joint Disease Activity Score (DAS28)] in both groups. The secondary endpoint was the patients' adherence to their medications. There was no significant difference between disease activity measures as well as DAS28 and RAPID-3 scores at 3, 6, and 12 months of management, although there was a trend toward lower patient-reported tender joint count and functional disability score in the active group versus the control group. The patients' adherence to antirheumatic therapy was significantly higher (p < 0.01) in the ePROM group, whereas stopping disease-modifying antirheumatic drugs for intolerability was significantly higher (p < 0.01) in the control group at 12 months of treatment. We found ePROM equivalent to standard paper PROM format. Further, it enabled the patients to personally monitor how they are doing regarding their disease activity and helped to optimize their adherence to their treatment.

Brief Report: Estimating Disease Activity Using Multi-Biomarker Disease Activity Scores in Rheumatoid Arthritis Patients Treated With Abatacept or Adalimumab.

ObjectiveTo assess the ability of a multi‐biomarker disease activity (MBDA) test (Vectra DA) to reflect clinical measures of disease activity in patients enrolled in the AMPLE (Abatacept Versus Adalimumab Comparison in Biologic‐Naive RA Subjects with Background Methotrexate) trial.MethodsIn the AMPLE trial, patients with active rheumatoid arthritis (RA) who were naive to biologic agents and had an inadequate response to methotrexate were randomized (1:1) to receive subcutaneous abatacept (125 mg every week) or subcutaneous adalimumab (40 mg every 2 weeks), with background methotrexate, for 2 years. The MBDA score was determined using serum samples collected at baseline, month 3, and years 1 and 2. The adjusted mean change from baseline in the MBDA score was compared between the abatacept and adalimumab treatment groups. Cross‐tabulation was used to compare the MBDA score with the following clinical measures of disease activity: Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Disease Activity Score in 28 joints using the C‐reactive protein level (DAS28‐CRP), and Routine Assessment of Patient Index Data 3 (RAPID‐3).ResultsIn total, 318 patients were randomized to receive abatacept, and 328 were randomized to receive adalimumab; MBDA data were available for 259 and 265 patients, respectively. No association between the MBDA score and disease activity defined by the CDAI, SDAI, DAS28‐CRP, or RAPID‐3 in the abatacept and adalimumab treatment groups was observed.ConclusionThe MBDA score did not reflect clinical disease activity in patients enrolled in AMPLE and should not be used to guide decision‐making in the management of RA, particularly for patients who receive abatacept or adalimumab as the first biologic agent.

Prediction of Remission in a French Early Arthritis Cohort by RAPID3 and other Core Data Set Measures, but Not by the Absence of Rheumatoid Factor, Anticitrullinated Protein Antibodies, or Radiographic Erosions.

To identify baseline variables that predict remission according to different criteria in rheumatoid arthritis (RA) in a comprehensive French ESPOIR early arthritis database. Individual variables and indices at baseline were analyzed in 664 patients for capacity to predict remission either 6 or 12 months later according to 4 criteria that require a formal joint count: the American College of Rheumatology/European League Against Rheumatism Boolean criteria, the Simplified Disease Activity Index, the Clinical Disease Activity Index, and the 28-joint Disease Activity Score; and 2 remission criteria that do not require a formal joint count: the Routine Assessment of Patient Index Data 3 (RAPID3) and the RAPID3 ≤ 3 + swollen joint, using univariate and multivariate logistic regressions. Remission was predicted significantly 6 and/or 12 months later in 26.8%-51.4% of patients, according to all 6 criteria by younger age, low index scores, and better status for the 6/7 clinical RA core dataset measures: tender joint count, swollen joint count (SJC), physician's global estimate, patient self-report Health Assessment Questionnaire (HAQ) physical function, pain, and patient's global estimate. Remission was not predicted by the absence of "poor prognosis RA" indicators, rheumatoid factor (RF), anticitrullinated protein antibodies (ACPA), or radiographic erosions. In multivariate regressions that included only 3 variables, low HAQ function predicted remission by all criteria as effectively as SJC, erythrocyte sedimentation rate, or C-reactive protein. Younger age and 6 core dataset clinical measures, but not the absence of traditional "poor prognosis RA" indicators, RF, ACPA, or radiographic erosions, predicted remission according to 6 criteria, including 2 without a formal joint count.

Reductions in disease activity in the AMPLE trial: clinical response by baseline disease duration

ObjectivesTo evaluate clinical response by baseline disease duration using 2-year data from the AMPLE trial.MethodsPatients were randomised to subcutaneous abatacept 125 mg weekly or adalimumab 40 mg bi-weekly, with background...

One-year maintenance with routine assessment of patient index data 3-based remission may inhibit radiographic progression in patients with rheumatoid arthritis treated with routine clinical therapy: A retrospective comparison of radiographic outcome and its prognostic factors between maintained remissions with patient-reported outcome index and physician-oriented disease activity indices

Objectives: We investigated whether the maintenance of routine assessment of patient index data 3 (RAPID3) remission for one year (RAPID3-MR) may predict good radiographic outcomes. We also compared radiographic progression to prognostic factors among patients with RAPID3-MR, with the maintenance of clinical disease activity index remission for one year (CDAI-MR) or with the maintenance of 28 joint count disease activity score remission for one year (DAS28-MR).Methods: Of 1220 patients with available clinical data, 92 with RAPID3-MR, 80 with RAPID3-NMR (not satisfying RAPID3-MR), 45 with CDAI-MR, and 75 with DAS28-MR were retrospectively investigated. CDAI and DAS28 for clinical outcomes and the modified total Sharp score (mTSS) for radiographic joint damage were investigated for at least one year.Results: RAPID3, CDAI, DAS28, and their categories remained unchanged or significantly improved in RAPID3-MR patients but significantly deteriorated in RAPID3-NMR patients. The mean annual ΔmTSS was significantly lower in RAPID3-MR patients (0.12 ± 0.55) than in RAPID3-NMR patients (0.54 ± 1.27) (p = 0.025). There was no significant difference among RAPID3-MR patients, CDAI-MR patients (0.06 ± 0.85), and DAS28-MR patients (0.11 ± 0.89). The baseline mTSS (p = 0.038) and monotherapy with nonbiological disease-modifying antirheumatic drugs (p = 0.033) were good prognostic factors in RAPID3-MR patients.Conclusions: One-year RAPID3 remission maintenance may predict good radiographic outcomes.

Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity.

IntroductionThe effect of certolizumab pegol (CZP) on patient-reported outcomes (PROs) was investigated in 1063 patients with rheumatoid arthritis (RA) from the REALISTIC trial (double-blind, placebo-controlled to week 12, open-label to week 28; randomized 4:1 [CZP:placebo]). Correlations between PROs and RA signs and symptoms, and the relative efficacy of these measures, were examined.MethodsAdults with RA and an inadequate response to at least one disease-modifying antirheumatic drug were enrolled. PROs assessed included physical function (using the Health Assessment Questionnaire-Disability Index), pain, fatigue, sleep disturbance, Patient Global Assessment of Disease Activity (PtGA), Routine Assessment of Patient Index Data 3 (RAPID3), and Rheumatoid Arthritis Disease Activity Index (RADAI).ResultsEarly significant and clinically meaningful improvements in all PROs were observed to week 12 with CZP vs. placebo and were maintained to the end of the trial (week 28). At week 12, up to one-third more CZP patients showed improvements compared with placebo that were greater than or equal to the minimal clinically important difference (MCID) in fatigue, sleep problems, pain, PtGA, RADAI, and RAPID3. The changes in PROs were correlated with clinical measures of disease activity, including the Disease Activity Score in 28 joints using C-reactive protein as well as tender and swollen joint counts.ConclusionsRapid improvements in PROs were seen in patients with RA treated with CZP. The magnitude of improvement exceeded the MCID in multiple domains and demonstrated that CZP improves aspects of health-related quality of life that are meaningful to patients and superior to placebo. PROs provide information complementary to clinical outcomes in assessment of treatment benefits.Trial registrationClinicalTrials.gov identifier: NCT00717236. Registered on 15 July 2008.