Physician Assessment Of Disease Activity Research Articles

Determinants of patient and physician global assessments of disease activity in anti-neutrophil cytoplasmic antibody-associated vasculitis.

To compare physician and patient assessments of global disease activity in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) and to identify associated factors. Global disease activity scores (0-10 points) were retrospectively analyzed from physicians and patients with AAV at each outpatient visit from 2010 to 2020. We compared the scores and performed a linear regression with a random effects to identify associated factors. Patients (n = 143, 1,291 pairs, 52% female) had a mean 64 (±15) years of age and a mean disease duration of 9 (±7) years. Patients and physicians global disease activity assessments showed a moderate correlation (Pearson R 0.31, CI [0.23-0.52], p < 0.001). Linear regression showed a strong association between the physician-documented disease activity scores and serum CRP levels (β = 0.22, CI [0.18, 0.28]), disease duration (β = -0.022, CI [-0.04,-0.01]) and patients' assessment of disease activity (β = 0.08, CI [0.04, 0.12]). By contrast, patient assessments were strongly associated with the degree of pain (β = 0.30, CI [0.25, 0.35]), functional limitations in daily living (HAQ, β = 0.49, CI [0.21, 0.78]) and the global physical well-being (NRS, β = 0.39, CI [0.32, 0.46]). Patients' and physicians' assessments of disease activity correlated. High CRP levels and disease duration were associated with physician-assessed disease activity scores, while subjective limitations were associated with higher patient-assessed disease activity scores. These findings highlight and support the need to develop and evaluate patient-reported outcomes to assess disease activity in patients diagnosed with AAV.

Perceived Stress and Prediction of Worse Disease Activity and Symptoms in a Multiracial, Multiethnic Systemic Lupus Erythematosus Cohort.

Studies have suggested a potential link between traumatic experiences, psychological stress, and autoimmunity, but the impact of stress on disease activity and symptom severity in systemic lupus erythematosus (SLE) remains unclear. The present study was undertaken to examine whether increases in perceived stress independently associate with worse SLE disease outcomes over 3 years of follow-up. Participants were drawn from the California Lupus Epidemiology Study (CLUES). Stress was measured annually using the 4-item Perceived Stress Scale (PSS). Participants with increases of ≥0.5 SD in PSS score were defined as having an increase in stress. Four outcomes were measured at the year 3 follow-up visit: physician-assessed disease activity (Systemic Lupus Erythematosus Disease Activity Index); patient-reported disease activity (Systemic Lupus Activity Questionnaire); pain (Patient-Reported Outcomes Measurement Information System [PROMIS] pain interference scale); and fatigue (PROMIS fatigue scale). Multivariable linear regression evaluated longitudinal associations of increase in stress with all 4 outcomes while controlling for potential confounders. The sample (n=260) was 91% female, 36% Asian, 30% White, 22% Hispanic, and 11% African American; the mean ± SD age was 46 ± 14 years. In adjusted longitudinal analyses, increase in stress was independently associated with greater physician-assessed disease activity (P=0.015), greater self-reported disease activity (P < 0.001), more pain (P=0.019), and more fatigue (P < 0.001). In a racially diverse sample of individuals with SLE, those who experienced an increase in stress had significantly worse disease activity and greater symptom burden at follow-up compared to those with stress levels that remained stable or declined. Findings underscore the need for interventions to bolster stress resilience and support effective coping strategies among individuals living with lupus.

Development and Validation of a Juvenile Spondyloarthritis Disease Flare Measure: Ascertaining Flare in Patients With Inactive Disease.

Our objective was to develop and validate a composite disease flare definition for juvenile spondyloarthritis (SpA) that would closely approximate the clinical decision made to reinitiate or not reinitiate systemic therapy after therapy de-escalation. Retrospective chart reviews of children with SpA who underwent systemic therapy de-escalation of biologic or conventional disease-modifying antirheumatic drugs were used to develop and validate the flare outcome. Data on independent cohorts for development (1 center) and validation (4 centers) were collected from large tertiary health care systems. Core measure thresholds and candidate disease flare outcomes were assessed using sensitivity, specificity, positive predictive values (PPVs) and negative predictive values (NPVs), and the receiver operating characteristic (ROC) area under the curve (AUC), with physician assessment of active disease plus re-initiation of standard dose of systemic therapy as the reference standard. Of the candidate definitions, clinically meaningful worsening in ≥3 of the following 5 core measures performed best: caregiver/patient assessment of well-being; physician assessment of disease activity; caregiver/patient assessment of pain, physical function, and active joint count. The ROC AUC was 0.91, PPV 87.5%, NPV 98.1%, sensitivity 82.4%, and specificity 98.7%. Cronbach's α was 0.81, signifying internal consistency, and factor analysis demonstrated that the outcome measured 1 construct. The Juvenile SpA Flare measure had face validity according to 21 surveyed pediatric rheumatologists. Juvenile SpA Flare had an ROC AUC of 0.85, a PPV of 92.3%, and an NPV of 96.8% in the validation cohort. There is initial support for the validity of the Juvenile SpA Flare measure as a tool to identify disease flare in juvenile SpA patients de-escalating therapy, and the measure is potentially applicable in clinical practice, observational studies, and therapeutic trials.

Performance of the Rheumatoid Arthritis Disease Activity Index in the Assessment of Disease Activity in Rheumatoid Arthritis-Findings From the REAL Study.

Although telemedicine use has been under discussion for decades, this topic has gained unprecedented importance during the COVID-19 pandemic. The Rheumatoid Arthritis Disease Activity Index (RADAI) is a user-friendly tool, fully self-administered, to assess rheumatoid arthritis (RA) disease activity. The aim of this study was to compare the performance of RADAI with other disease activity indices, functional status, and inflammatory markers in a large cohort of RA patients. We assessed the concurrent validity of RADAI against Clinical Disease Activity Index (CDAI), Disease Activity Score in 28 Joints-C-reactive protein, Disease Activity Score in 28 Joints-erythrocyte sedimentation rate, Simplified Disease Activity Index, and physician assessment of disease activity and the correlation of RADAI with Health Assessment Questionnaire-Disability Index and inflammatory markers at the REAL Study baseline. We also evaluated the correlation of the change in RADAI and the change in CDAI over a 6-month follow-up. From the 1115 patients included in the REAL Study, 1113 had RADAI scores in the first assessment. At baseline, correlations between RADAI and other disease activity indices were strong, ranging from 0.64 (comparison with physician assessment) to 0.79 (comparison with CDAI). Correlation between the change in RADAI score over the 6 months of follow-up and the change in CDAI score over the same period was moderate/strong for the overall group and within the stratified analyses. The strong correlation of RADAI with other well-established tools for disease activity measurement reassures its use with RA patients' follow-up, especially in this new era of telemedicine.

Factors Associated With Use of Telemedicine for Follow-Up of SLE in the COVID-19 Outbreak.

Objective: To investigate the factors associated with telemedicine (TM) use for follow-up of Systemic Lupus Erythematous (SLE) patients in the COVID-19 pandemic.Methods: This was a single-centered cross-sectional study conducted in Hong Kong. Consecutive patients followed up at the lupus nephritis clinic were contacted for their preference in changing the coming consultation to TM in the form of videoconferencing. The demographic, socioeconomic, and disease data of the first 140 patients opted for TM and 140 control patients preferred to continue standard in-person follow-up were compared.Results: The mean age of all the participants was 45.6 ± 11.8 years, and the disease duration was 15.0 ± 9.2 years. The majority of them were on prednisolone (90.0%) and immunosuppressants (67.1%). The mean SLEDAI-2k was 3.4 ± 2.4, physician global assessment (PGA) was 0.46 ± 0.62 and Systemic Lupus International Collaborating Clinics (SLICC) damage index was 0.97 ± 1.23. A significant proportion of the patients (72.1%) had 1 or more comorbidities. It was found that patients with higher mean PGA (TM: 0.54 ± 0.63 vs. control: 0.38 ± 0.59, p = 0.025) and family monthly income > USD 3,800 (TM: 36.4% vs. control: 23.6%; p = 0.028) preferred TM, while full-time employees (TM: 40.0% vs. control: 50.7%; p = 0.041) preferred in-person follow-up. These predictors remained significant in the multivariate analysis after adjusting for age and gender. No other clinical factors were found to be associated with the preference of TM follow-up.Conclusion: When choosing the mode of care delivery between TM and physical clinic visit for patients with SLE, the physician-assessed disease activity and patient's socio-economic status appeared to be important.

P170 Correlation between health-related quality of life and smartphone-based self-assessment of activity index in patients with ulcerative colitis

Abstract Background E-health platform can facilitate remote monitoring of ulcerative colitis (UC) patients. A recent study shows that patient-administered simple clinical colitis activity index (SCCAI) via online correlated well with physician-assessed SCCAI. We evaluated the correlation between the self-administered SCCAI through smartphone and health-related quality-of-life assessment. Methods Clinical disease activity was assessed by the SCCAI and health-related quality of life by the disease-specific, self-administered Inflammatory Bowel Disease Questionnaire (IBDQ). Patients were followed-up over six months. At months 3 and 6, patients completed SCCAI through access to the web-based system (PROscore system) via link sent by text message to the smartphone at the outside of the hospital; within 48 h, patients subsequently completed the questionnaire of IBDQ in the clinic and attending gastroenterologist (blinded to patients’ scores) assessed the in-clinic SCCAI (reference). SCCAI scores were categorized into remission or active disease. Results A total of 157 patients (median age: 41 years; 62% male) contributed with 310 pairs of questionnaires. SCCAI scores by patients inversely correlated well with IBDQ (Pearson’s ρ =0.39). Moreover, linear regression revealed that this correlation persists irrespective of patient age, gender, disease extent, and education status. Correlation of SCCAI scores by patients and physicians was good (Spearman’s ρ =0.36), with 66% agreement for remission or active disease. The negative predictive value for the active disease was 84.3%; the positive predictive value was 41.2.0%. Conclusion In patients with UC, self-administered SCCAI via smartphone showed a good correlation with physician assessed disease activity and the patient’s quality of life. This validated e-health platform may be useful in remote monitoring of UC patients.

Impact of Limited Health Literacy on Patient-Reported Outcomes in Systemic Lupus Erythematosus.

Health disparities in patient-reported outcomes by income and education are well documented; however, the impact of health literacy on patient-reported outcomes has received less attention. We examined independent effects of income, education, and health literacy on patient-reported outcomes in systemic lupus erythematosus (SLE). Data from the California Lupus Epidemiology Study (n = 323 participants) were used. Health literacy was assessed with a validated 3-item measure (ability to understand written information, reliance on others to understand written information, confidence in completing written forms). Patient-reported outcomes were administered by interview in English, Spanish, Cantonese, or Mandarin. Generic and disease-specific patient-reported outcomes were examined using the following: 10 Patient-Reported Outcomes Measurement Information System (PROMIS) short forms; the 8 Short Form 36 (SF-36) health survey subscales; and 3 patient-reported SLE disease activity and damage measures. We conducted 2 sets of multivariable analyses: the first examined education, income, or health literacy individually; the second included all 3 simultaneously. All multivariable models included age, sex, race/ethnicity, language, disease duration, and physician-assessed disease activity and damage. More than one-third of participants (38%) had limited health literacy (LHL), including >25% with greater than high school education. In multivariable analyses simultaneously considering education, income, and health literacy, LHL was associated with significantly worse scores on all patient-reported outcomes except disease damage. In contrast, disparities by income were seen in only 3 PROMIS scales, 3 SF-36 subscales, and 1 disease activity measure. No disparities by education level were noted. We found significantly worse patient-reported outcome scores among individuals with LHL, even after controlling for disease activity and damage. Whether disparities are due to actual differences in health or measurement issues requires further study.

Psychometric Evaluation of the National Institutes of Health Patient-Reported Outcomes Measurement Information System in a Multiracial, Multiethnic Systemic Lupus Erythematosus Cohort.

We examined psychometric performance of Patient-Reported Outcomes Measurement Information System (PROMIS) measures in a racially/ethnically and linguistically diverse cohort with systemic lupus erythematosus (SLE). Data were from the California Lupus Epidemiology Study, a multiracial/multiethnic cohort of individuals with physician-confirmed SLE. The majority (n = 332) attended in-person research visits that included interviews conducted in English, Spanish, Cantonese, or Mandarin. Up to 12 PROMIS short forms were administered (depending on language availability). An additional 99 individuals completed the interview by phone only. Internal consistency was examined with Cronbach's alpha and item-total correlations. Correlations with the Short Form 36 subscales and both self-reported and physician-assessed disease activity assessed convergent validity. All analyses were repeated within each racial/ethnic group. Differences in scores by race/ethnicity were examined in bivariate analyses and by multiple regression analyses controlling for age, sex, disease duration, and disease damage and activity. The total sample was 30.0% white, 22.3% Hispanic, 10.9% African American, 33.7% Asian, and 3.0% other race/ethnicity. Seventy-seven percent of interviews were conducted in-person. Non-English interviews were conducted in 26.0% of the Hispanic subjects and 18.6% of the Asian subjects. Each scale demonstrated adequate reliability and validity overall and within racial/ethnic groups. Minimal floor effects were observed, but ceiling effects were noted. Missing item responses were minimal for most scales, except for items related to work. No differences were noted by mode of administration or by language of administration among Hispanics and Asians. After accounting for differences in disease status, age, and sex, few differences in mean scores between whites and other racial/ethnic groups were noted. PROMIS measures appear reliable and valid in persons with lupus across racial/ethnic groups.

Patient-Reported Outcomes Predict Mortality in Lupus.

Physician-assessed disease activity and damage predict mortality in systemic lupus erythematosus (SLE). Patient-reported outcomes (PROs) are known predictors of mortality in other chronic diseases, but this relationship has not been well examined in SLE. The aim of the present study was to assess whether PROs predict mortality in SLE. Data were derived from the University of California at San Francisco Lupus Outcomes Study (n = 728). PROs (Medical Outcomes Study Short Form 36 [SF-36] subscales), self-rated health, and depression (Center for Epidemiologic Studies Depression scale [CES-D]) from 2007 (baseline data [T0]) were used to predict mortality (censored 2015). Univariate Cox regression analyses were completed for each PRO as a predictor of mortality, and multivariate Cox regression with covariates for each PRO separately. Covariates were age, sex, race/ethnicity, poverty, disease duration, disease activity (Systemic Lupus Activity Questionnaire), and damage (Brief Index of Lupus Damage). The mean ± SD age of patients was 50.6 ± 12.6 years. Ninety-two percent of patients were women and 68.5% were white. There were 71 deaths (9.1%). In univariate analyses, both the SF-36 physical component subscale score and self-rated health were associated with mortality, and the SF-36 mental health subscale and CES-D scores were not associated with mortality. In multivariate analyses, lower scores of SF-36 physical function at T0 independently predicted mortality after controlling for all other covariates (hazard ratio 0.97 [95% confidence interval 0.94-0.99]; P < 0.01). Patient-reported physical function independently predicted mortality in SLE, even after accounting for demographics (including poverty) and disease (duration, activity, and damage). Because PROs are easy to assess, they may be used to triage, track, and guide early interventions for those at high risk of mortality in SLE.

Discordance between doctor and patient assessments and non-adherence to subcutaneous biological drugs.

To estimate the agreement level between patient and physician assessment of disease activity and to explore whether agreement is associated with adherence to subcutaneous (SC) biological drugs in rheumatoid arthritis (RA). Cross-sectional study of RA patients who had been prescribed a SC biological drug in the past 12-18monthswas performed. Patients and physicians global disease activity on visual analogue scale (VAS) were collected. Disagreement was defined as an absolute difference ≥ 3 points between VAS scores. Adherence was assessed by the Medication Possession Ratio (MPR), considering adherence an MPR > 80%. We analysed 360 patients of whom 15.5% presented disagreement with their physicians. The mean patient global VAS was 5.75 ± 1.8 (median 5.5 [5-7]) in the disagreement group versus 2.7 ± 2.2 (median 2 [1-4]) in the agreement group (p < 0.001). There were also differences in physicians global VAS between groups (p = 0.01). The non-adherence to SC biological drugs rate was 10.7% and 14.5% in the disagreement and agreement groups (p = 0.45). No association between adherence and discordance was found. Disagreement in the global disease activity between patients and physicians was detected in 15.5% of patients. In general, patients perceived higher disease activity. No associations between patient-physician disagreement in VAS and adherence were observed.

Patient-Reported Disease Activity and Adverse Pregnancy Outcomes in Systemic Lupus Erythematosus and Rheumatoid Arthritis.

While increased rheumatic disease activity during pregnancy has been associated with adverse pregnancy outcomes, this disease activity is typically assessed by physicians. Little is known, however, about the association between patient-reported measures of disease activity and pregnancy outcomes. The aim of our study was to evaluate this association. Univariate and multivariable regression models were used to assess the relationship between patient- and physician-reported measures of disease activity and adverse pregnancy outcomes in 225 patients with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The patients were enrolled from 2008-2016 in a prospective registry at a single academic center. In women with RA, patient-reported disease activity was associated with preterm birth (odds ratio [OR] 5.9 [95% confidence interval (95% CI) 1.5, 23.9]) and gestational age in weeks (β = -1.5 [95% CI -2.6, -0.4]). The physician assessment of disease activity also predicted preterm (OR 2.1 [95% CI 1.2, 3.5]), small for gestational age births (OR 1.8 [95% CI 1.03, 3.1]), and gestational age in weeks (β = -0.6 [95% CI -0.9, -0.02]). Alternatively, in women with SLE, patient-reported disease activity measures, including the Health Assessment Questionnaire, pain, or global health measures, were not associated with adverse pregnancy outcomes. However, physician measures of SLE disease activity are associated with preterm birth (OR 2.9 [95% CI 1.3, 6.3]), cesarean delivery (OR 2.3 [95% CI 1.0, 5.3]), and preeclampsia (OR 2.8 [95% CI 1.3, 6.3]). The results did not appear to be driven by lupus nephritis or antiphospholipid syndrome. For women with RA, patient-reported measures of disease activity were associated with adverse pregnancy outcomes, and thus may be useful adjuncts to physician-reported measures in identifying pregnancies at greater risk. In contrast, in SLE, while physician measures of disease activity helped predict several adverse pregnancy outcomes, no patient-reported measures were associated with adverse outcomes.

Validation of SIMPLE Index for Lupus Disease Activity

An easy, quick tool requiring minimal training or health care provider input would potentially have greater uptake for clinical use among rheumatologists and primary care physicians for assessment of disease activity in systemic lupus erythematosus (SLE). SIMPLE (SIMple Disease Assessment for People with Lupus Erythematosus) index is a composite numeric tool that is easy and quick to calculate. We prospectively assessed the performance of the SIMPLE index as a disease activity surrogate against physician-based disease activity measures. Ninety-nine consenting patients meeting American College of Rheumatology SLE classification criteria were recruited. Safety of Estrogen in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI), physician global assessment, and SIMPLE index were obtained during routine visits. SIMPLE index is a 17-item patient-reported questionnaire that includes 2 laboratory tests. Health care provider input is needed only to provide laboratory results (normal/abnormal) and confirming patient-reported current use and dosing of glucocorticoids. We performed Spearman test to assess correlation of SIMPLE index with SELENA-SLEDAI and physician global assessment. Mean age (SD) was 39.7 (12.3) years. The correlation coefficient between SIMPLE index and SELENA-SLEDAI was 0.56 (P = 0.0001), and that between SIMPLE index and physician global assessment was 0.54 (P = 0.0001). In SLE patients without fibromyalgia (FM), the correlation of SIMPLE index with SELENA-SLEDAI and physician global assessment was 0.58 (P = 0.0001) and 0.57 (P = 0.0001), respectively. SIMPLE index is strongly correlated with formal physician assessments of disease activity in SLE, and correlation was marginally higher among those without FM. SIMPLE index can be performed easily in places with limited physician and laboratory resources.

Changes in health-related quality of life over a 1-year follow-up period in children with inflammatory bowel disease.

Little is known about disease-specific health-related quality-of-life (HRQoL) changes over time in paediatric patients with inflammatory bowel disease (IBD), and about their associations with baseline medical characteristics. In this study, 153 paediatric patients with IBD from the multicentre prospective Swiss IBD cohort study were included at baseline. Of these, 90 patients were analysed at a 1-year follow-up. Medical data were extracted from hospital records, while HRQoL data were measured using the standardized, self-report disease-specific IMPACT-III questionnaire. The IBD diagnosis of the included children was made an average of 2.0 years before their baseline assessment. Over the 1-year follow-up period, a significant increase in overall HRQoL and in the HRQoL domain 'physical functioning' was evident. On multivariate analysis, overall HRQoL changes over time were predicted by baseline HRQoL, baseline disease activity, and disease activity changes over time. HRQoL improvements were significantly associated with decreases in physician-assessed disease activity. Children reporting a low baseline HRQoL and children with inactive or mildly-active disease experienced greater improvements. Children with more severe baseline disease activity had the greatest risk for HRQoL deterioration over the 1-year follow-up period. However, among possible factors that might influence HRQoL changes over time, the child's medical characteristics explained only a small proportion of their variability in our sample. We, therefore, recommend that researchers and clinicians focus on factors that are not incorporated within the multidimensional HRQoL concept if they seek to gain better insights into factors that influence HRQoL changes over time in children with IBD.

Disease activity in and quality of life of patients with psoriatic arthritis mutilans: the Nordic PAM Study

Objective: To describe the social status and health-related quality of life of patients with psoriatic arthritis mutilans (PAM) in the Nordic countries.Method: Patients with at least one mutilated joint confirmed by radiology were studied. Disease activity involving joints and skin, physician-assessed disease activity, and patient’s education and work status were recorded. Data from the 36-item Short Form Health Survey, Health Assessment Questionnaire and Dermatology Life Quality Index questionnaire were gathered and correlated with disease duration, pain, and general well-being (visual analogue scale). The controls were 58 Swedish patients with long-standing psoriatic arthritis sine PAM.Results: Sixty-seven patients were included. Patients with PAM had a protracted disease history (33 ± 14 years) and disease onset at a relatively early age (30 ± 12 years). Overall inflammatory activity at inclusion was mild to moderate. The mean number of mutilated joints was 8.2 and gross deformity was found in 16% of patients. Forty per cent were treated with biological and 32% with conventional synthetic disease-modifying anti-rheumatic drugs. Forty-two per cent had retired early or were on sick leave. Impaired functional capacity with little or no ability to perform self-care or everyday tasks was reported by 21% of the patients. Patients between 45 and 60 years of age reported the most impaired quality of life in comparison to the control group.Conclusion: PAM seriously affects social functioning. Whether early recognition of PAM and new forms of therapy can improve disease outcome and quality of life remains to be studied.

The Psoriatic Arthritis Impact of Disease 12-item questionnaire: equivalence, reliability, validity, and feasibility of the touch-screen administration versus the paper-and-pencil version.

BackgroundOver the last few years, there has been a shift toward a more patient-centered perspective of the disease by adopting patient-reported outcomes. Touch-screen formats are increasingly being used for data collection in routine care and research.ObjectivesThe aim of this study is to examine the equivalence, reliability, validity and respondent preference for a computerized touch-screen version of the Psoriatic Arthritis Impact of Disease 12-item (PsAID-12) questionnaire in comparison with the original paper-and-pencil version, in a cohort of patients with psoriatic arthritis (PsA).MethodsOne hundred and fifty-nine patients with PsA completed both the touch screen- and the conventional paper-and-pencil administered PsAID-12 questionnaire. Agreement between formats was assessed by intraclass correlation coefficients. Spearman’s rho correlation coefficient was used to test convergent validity of the touch screen format of PsAID-12, while receiver operating characteristic curve analysis was performed to test discriminant validity. In order to assess the patient’s preference, the participants filled in an additional questionnaire. The time taken to complete both formats was measured.ResultsA high concordance between the responses to the two modes of the PsAID-12 tested was found, with no significant mean differences. Intraclass correlation coefficients between data obtained for touch-screen and paper versions ranged from 0.801 to 0.962. There was a very high degree of correlation between the touch-screen format of PsAID-12 and composite disease activity indices (all at a P level <0.0001), Health Assessment Questionnaire, and Physician Assessment of disease activity. The discriminatory power of the touch-screen format of PsAID-12, assessed using the minimal disease activity – Outcome Measurements in Rheumatology Clinical Trials criteria, was very good, with an area under the receiver operating characteristic curve of 0.937 and a resulting cutoff value of 2.5. The touch-screen questionnaire was readily accepted and preferred. The mean time spent for completing the questionnaire on touch screen was 2 minutes and on paper was 2.7 minutes.ConclusionThe touch-screen mode of administration of PsAID-12 can be a feasible and suitable alternative to the paper-and-pencil mode for the assessment of patients with PsA.

Development of the ClinESSDAI: a clinical score without biological domain. A tool for biological studies

ObjectiveTo develop and validate ClinESSDAI (Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index), ie, ESSDAI without the biological domain.Patients and methodsThe 702 fictive vignettes derived from 96 real...

Lupus Impact Tracker is responsive to physician and patient assessed changes in systemic lupus erythematosus.

To evaluate the responsiveness of Lupus Impact Tracker (LIT) to changes in physician and patient disease activity assessments over time. Available longitudinal data from routine patient care visits on LIT, physician assessed disease activity (physician global assessment (PGA), SELENA-SLEDAI score, SELENA Flare Index (SFI)), and patient-reported changes in systemic lupus erythematosus (SLE) health status were analyzed. Significant, clinically important change (worsening or improvement) in physician disease activity assessment or patient-reported SLE health status were judged using the following criteria: change of 0.3 on PGA, 4 on SELENA-SLEDAI, change in SFI status over time, and change of 2 in either direction in patient-reported SLE health status. Mixed model regression analysis was used to compare changes in LIT using the above criteria. There were 1184 observations with significant changes in physician disease activity or patient-reported measure for 182 patients' data across 1364 visits. Patients' mean (SD) age and SELENA-SLEDAI were 43.5 (13.2) years and 6.4 (7.3) respectively. LIT mean scores decreased by more than 3 with improvement in PGA (standardized response mean -0.26, p < 0.05), while it increased by more than 5 with worsening in SELENA-SLEDAI (standardized response mean 0.42, p = 0.01). Mean change in LIT of greater than ±3 was noted with change in SFI status (p < 0.05). Mean LIT score decreased by greater than 4 and increased by greater than 2 with patient-reported improvement and worsening in SLE health status respectively (p < 0.05). LIT is responsive to physician-assessed and patient-assessed changes in disease status. A mean LIT change of 2-4 may represent a significant clinical change in LIT. It is an effective tool that may be used by patients and physicians in tracking disease impact in SLE patients.

Sa1198 Initial Vedolizumab Cohort: Patient Characteristics and Clinical Response

Background: Vedolizumab, an α4β7 integrin antibody, was recently approved for use in Crohn's disease (CD) and ulcerative colitis (UC). Characteristics of patients with inflammatory bowel disease (IBD) who receive vedolizumab in clinical practice, and efficacy of vedolizumab in this patient population, is unknown. Objective: To characterize the background medical history and response of patients receiving vedolizumab in a referral center for IBD. Methods: All patients with IBD who received at least one dose of vedolizumab were identified. Demographics, IBD history, abdominal surgery history, comorbid diagnoses, laboratory results, and physician assessment of disease activity were abstracted from medical records. Results: Medical record data were abstracted from 62 IBD patients receiving at least one dose of vedolizumab from July 2014 through early November 2014. The median duration of vedolizumab use was 102 days, ranging from 1 to 129 days. Forty-eight patients had CD, 12 had UC, and 2 had indeterminate colitis. There were 23 (37%) males, and 58 (94%) were white. The average age was 38 (+/-3) years. The mean duration of disease for CD and UC patients was 19 years (+/5) and 31 years (+/-7), respectively. Nearly all patients had used biologic therapy (n=60, 97%); 34 (57%) also had at least one intestinal resection. More than two-thirds had discontinued 2 or more biologics (n=45, 73 %) and almost half had discontinued 3 or more biologics (n=27, 44%). Among subjects with CD, 17 (40%) had penetrating disease, and 14 of these also had perianal disease. Eight (75%) UC patients had pancolitis. Depression or anxiety affected 19 (31%) subjects. CRP rose from baseline to week 6 in CD patients (mean rate 1.21, 95% CI 1.05-1.54), but significant changes in CRP from baseline to week 12 were not observed (mean rate 1.18, 0.93-1.29). Among UC patients, no changes in CRP were observed from baseline to week 6 (2.01, 0.86-4.69) nor from baseline to week 12 (0.86, 0.29-2.56). Six patients were hospitalized while receiving vedolizumab for worsening IBD (median 47 days after initial infusion). Vedolizumab was discontinued in 4 patients (median 45 days after initial infusion): 3 for non-response and 1 due to an infusion reaction . Of the 33 subjects who have been on the medication for at least 12 weeks, patients' physicians assessed that 6 (18%) patients achieved remission, 16 (48%) had partial response, and 11 (33%) had no response. Conclusion: Patients receiving vedolizumab at a referral IBD center had severe disease history, including prior resection and failure of multiple biologic therapies. These findings should be taken in the context of the patient population with a history of severe and medically refractory disease, the short follow-up period, and relative lack of clinical measures in the medical record retrospectively assessing response to medications.

Development and retrospective validation of the juvenile spondyloarthritis disease activity index.

To develop and validate the Juvenile Spondyloarthritis Disease Activity Index (JSpADA) for use in clinical practice and research. Using modified Delphi consensus techniques, 10 items were selected by participants in the international pediatric rheumatology listserv, the Childhood Arthritis and Rheumatology Research Alliance, and the listserv for the pediatric section of the American College of Rheumatology. Validation was performed in a retrospective multicenter cohort of 244 children. In total, 106 physicians representing 14 countries completed the initial questionnaire. Completion rates for the subsequent questionnaires were 84%, 75%, and 77% of the original respondents. Ten items exceeded 80% consensus: arthritis, enthesitis, patient pain assessment, inflammatory markers, morning stiffness, clinical sacroiliitis, uveitis, back mobility, and patient and physician assessments of disease activity. After item analysis, 2 items were eliminated (patient and physician assessments of disease activity). Factor analysis identified 3 primary domains that explained 58% of the variance: peripheral disease, axial disease, and uveitis. The Cronbach's α coefficient was 0.66. The JSpADA had high or moderate correlations with the Juvenile Arthritis Disease Activity Score (r = 0.81), patient and physician assessments of disease activity (r = 0.70 and r = 0.66, respectively), and the Childhood Health Assessment Questionnaire (r = 0.56). The JSpADA discriminated well between subjects with active versus inactive disease (P < 0.001) and was responsive to improvement or worsening in disease activity over time (P < 0.001). Using international input and consensus formation techniques, we developed and validated the first disease activity assessment for juvenile spondyloarthritis. Future studies should validate the JSpADA in a prospective multicenter cohort.

THU0443 Increasing Disparities between Physician Assessment of Disease Activity and Patient Global Health in Germany between 2000 and 2012

BackgroundWe have seen remarkable achievements in disease control (DAS28) in rheumatoid arthritis in the past decade. They were, however, not accompanied to the same degree by improvements in patient reported...