Global Assessment Visual Analog Scale Research Articles

P184 A 24-month prospective psoriatic arthritis observational study of persistence of treatment - interim analysis of baseline characteristics

Abstract Background/Aims Ixekizumab (ixe), a highly selective interleukin (IL)-17A monoclonal antibody, has been approved for treatment of psoriatic arthritis (PsA). However, there is limited real-world evidence (RWE) available for ixe. PRO-SPIRIT is the first large-sample prospective observational study to provide RWE for ixe in patients (pts) with PsA. PRO-SPIRIT’s primary objective is to describe treatment persistence at 24 months (M) among pts with PsA who initiate or switch to a new biologic Disease-Modifying Arthritis Rheumatic Drugs (bDMARDs) or targeted synthetic (tsDMARDs), including ixe. This abstract describes the interim baseline (BL) characteristics. Methods PRO-SPIRIT is a prospective observational study, conducted in FR, ES, IT, DE, UK, and CA, enrolling adults with PsA (≥6M) to be initiated or switched to a new b/tsDMARD, locally approved for PsA. Treatment groups include ixe, secukinumab, IL-12/IL-23 inhibitors (i) (ustekinumab) or IL-23i (guselkumab), tumour necrosis factor (TNFi) (adalimumab, etanercept, infliximab or biosimilar), Janus kinase (JAKi) (tofacitinib or upadacitinib). Pt demographic, disease activity and therapy characteristics are collected at BL; clinical and patient-reported outcomes measures are collected at BL and at a routine post-BL visit. BL descriptive statistics are reported. Results From December 2019 until this interim data cut (June 2021), a total of 477 pts (305 female; mean age 52) were enrolled. Mean age ranged from 48 (IL-12/23i and IL-23i) to 55 (JAKi), with a majority of female pts in each group. Pts in the IL-12/23i and IL-23i and TNFi groups showed the shortest time since PsA diagnosis (5.2±4.5; 6.5±7.9), while pts in the JAKi group showed the longest time (10.6±9.4). The lowest proportion of pts with a prior b/tsDMARDs use was observed in the TNFi group (31%), the highest in the IL-12/23i and IL-23i group (71%). Pts in the ixe and IL-12/23i and IL-23i groups were more likely to be on monotherapy. Tender Joint Count (9.1-11.3) and Swollen Joint Count (3.3-5.8) were comparable across groups, with the highest values in the ixe and JAKi groups, respectively. Pt proportion with enthesitis and dactylitis was higher in the ixe, secukinumab and JAKi groups. Percentage of Body Surface Area affected by psoriasis was higher in the ixe, secukinumab and IL-12/23i and IL-23i groups. Pt proportion with nail psoriasis was higher in the ixe and secukinumab groups. Physician's Global Assessment Visual Analog Scale (VAS), Patient’s Global Assessment VAS and Patient's Assessment of Joint Pain VAS reflected a high burden of illness. Conclusion The reported BL characteristics offer preliminary information about which pts initiate or switch to a b/tsDMARD in a real-life setting. Future disclosures (at 12 and 24M) will provide RWE regarding persistence, effectiveness, and healthcare resource use of available treatments for PsA, which will help pts and physicians to make better informed treatment decisions. Disclosure J. Morel: Consultancies; J. Morel has been a speaker and/or consultant for: AbbVie, Amgen, Biogen, Bristol Myers Squibb, Eli Lilly and Company, Fresenius, Galapagos, Glaxo Smith Kline, Médac, Novartis, Sandoz, and Sanofi. Grants/research support; J. Morel has received grant funding/research support from: Biogen, Bristol Myers Squibb, Eli Lilly and Company, Novartis, and Pfizer. L. Dagna: Consultancies; L. Dagna has been a speaker and/or consultant for: AbbVie, Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, Celltrion, Lilly, Galapagos, GSK, Janssen, Kiniska, Pfizer, Roche, Sobi, and Sanofi. B. Ibañez: Grants/research support; B. Joven-Ibáñez has been a speaker for and has received grant funding/research support from: Eli Lilly and Company. T. Holzkaemper: Shareholder/stock ownership; T. Holzkaemper is a shareholder and employee of: Eli Lilly and Company. C. El Baou: Consultancies; C. El Baou has worked as a consultant for: Eli Lilly and Company. L. Unger: Other; L. Unger has been a speaker for: Eli Lilly and Company. A. Semeraro: None. N. Gullick: Consultancies; N. Gullick has been a speaker and/or consultant for: AbbVie, Celgene, Eli Lilly and Company, Janssen, Novartis, and UCB. Grants/research support; N. Gullick has received grant funding/research support from: AbbVie, AstraZeneca, Eli Lilly and Company, Izana, and Novartis. T. Treuer: Shareholder/stock ownership; T. Truer is a shareholder and employee of: Eli Lilly and Company.

Association between patient-reported outcomes and impairments in work and activity in patients with rheumatoid arthritis in clinical remission: A retrospective analysis using the IORRA database.

To explore the patient-reported outcomes (PROs) associated with work productivity and activity impairment (WPAI) in patients with rheumatoid arthritis (RA) in clinical remission. We enrolled patients with RA ≥18 years and with a simplified disease activity index ≤3.3 from the Institute of Rheumatology, Rheumatoid Arthritis data set collected in October 2017. The pain-visual analogue scale, patients' global assessment visual analogue scale (VAS), Japanese version of the Healthcare Assessment Questionnaire (J-HAQ) Disability Index, and duration of morning joint stiffness were selected as the PROs. To evaluate work productivity and activity, the WPAI for RA instrument (WPAI-RA) was used. To assess the contribution of each PRO to the WPAI-RA score, an analysis of variance model was constructed. The mean age of the 2614 patients was 62.4 years; 85.1% were female. Median values of the WPAI-RA score were 1.1% for absenteeism, 6.5% for presenteeism, 7.4% for work impairment, and 10.2% for activity impairment. Morning joint stiffness contributed the most to absenteeism (18.0%), while pain-VAS contributed the most to presenteeism (57.4%), work productivity loss (51.1%), and daily activity impairment (53.7%). J-HAQ was the second most contributing factor to presenteeism (17.4%), work productivity loss (16.3%), and daily activity impairment (26.0%). The pain-VAS and J-HAQ highly contributed to WPAI in patients with RA in clinical remission.

Increased Levels of Soluble CD206 Associated with Rapidly Progressive Interstitial Lung Disease in Patients with Dermatomyositis.

Objective Soluble CD206 (sCD206) is considered a macrophage activation marker, and a previous study proved it as a potential biomarker to predict the severity of anti-melanoma differentiation-associated gene 5- (anti-MDA-5-) positive dermatomyositis- (DM-) associated interstitial lung disease (ILD). To investigate the role of sCD206 in various subtypes of DM, we evaluated the serum level of sCD206 in patients with different myositis-specific autoantibodies besides anti-MDA-5 and clarified its clinical significance. Methods Commercial enzyme-linked immunosorbent assay kits were used to detect serum concentrations of sCD206 in 150 patients with DM and 52 healthy controls (HCs). Correlations between sCD206 levels and clinical features, laboratory examinations, and pulmonary function test parameters were analysed. Results The median concentrations of serum sCD206 in DM patients were significantly higher than those in HCs (p < 0.0001). Furthermore, median sCD206 levels were elevated in patients with ILD (p = 0.001), especially in those with rapidly progressive ILD (RP-ILD) (p < 0.0001). In addition, sCD206 levels were negatively correlated with the pulmonary function test results, including the percent predicted forced vital capacity (r = −0.234, p = 0.023), percent predicted forced expiratory volume in one second (r = −0.225, p = 0.030), and percent predicted carbon monoxide diffusion capacity (r = −0.261, p = 0.014). Age- and gender-adjusted multivariable analysis showed that sCD206 was an independent prognostic factor for RP-ILD in patients with DM. A longitudinal study showed that sCD206 levels were positively correlated with the physician global assessment visual analog scale scores (β = 54.201, p = 0.001). Conclusion Serum sCD206 levels were significantly increased in patients with DM and significantly associated with RP-ILD, suggesting that sCD206 is an important biological predictor of RP-ILD in patients with DM.

SAT0429 SECUKINUMAB IMPROVES CLINICAL AND PATIENT-REPORTED OUTCOMES AT 6 MONTHS AMONG PATIENTS WITH PSORIATIC ARTHRITIS IN THE US-BASED CORRONA PSORIATIC ARTHRITIS/SPONDYLOARTHRITIS (PsA/SpA) REGISTRY

Background:Secukinumab, an interleukin-17 antagonist approved for the treatment of PsA, improves all PsA manifestations in the GRAPPA-OMERACT core domain set.1Few US-based studies have evaluated the real-world effectiveness of secukinumab in patients with PsA.Objectives:To examine clinical and patient-reported outcomes (PROs) in patients with PsA enrolled in the Corrona PsA/SpA registry initiating secukinumab with ≥ 1 follow-up visit.Methods:Included were adult patients with PsA in the Corrona registry who initiated secukinumab after April 1, 2017 and remained on secukinumab at their 6-month (window, 5-8 months) follow-up visit. The primary outcome was achievement of minimal disease activity (MDA) at 6 months among patients not in MDA at secukinumab initiation. MDA was defined as meeting 5 of the 7 following criteria: tender joint count (TJC) ≤ 1, swollen joint count (SJC) ≤ 1, psoriasis affected body surface area (BSA) &lt; 3%, patient assessment of pain on visual analog scale (VAS) ≤ 15, patient global assessment VAS ≤ 20, HAQ-DI ≤ 0.5, and tender entheseal points ≤ 1 using the Leeds Enthesitis Index (LEI). Secondary outcomes included the proportion of patients who achieved resolution (0 sites) of TJC, SJC, enthesitis (using the LEI), and dactylitis among those with ≥ 1 site at initiation and improvement from baseline in clinical outcomes (BSA, nail psoriasis, physician global assessment, TJC, SJC, and DAPSA) and PROs (patient-reported pain, patient global assessment, HAQ-DI, and Work Productivity and Activity Impairment questionnaire) at 6 months. Outcomes were evaluated in the overall population and in potentially recalcitrant patients with failure of or intolerance to ≥ 3 previous biologics to examine if the later line biologic could be adequately effective.Results:A total of 100 patients with PsA who initiated and maintained secukinumab after 6 months were included. The mean (SD) age was 51.6 (11.6) years, 54.3% were male, and 96.8% were white. The mean (SD) symptom and disease duration were 10.8 (9.7) and 7.0 (7.0) years, respectively. Thirty patients (30.0%) initiated secukinumab 150 mg and 70 (70.0%) initiated secukinumab 300 mg. Most (83.0%) were biologic experienced; 17 patients initiated secukinumab as a 1st biologic, 34 as 2nd, 26 as 3rd, and 23 as ≥ 4th. At initiation, 75/90 patients (83.3%) were not in MDA; 26/71 (36.6%) of those with follow-up data available achieved MDA at 6 months (Figure 1). In the overall population, 28 patients (41.2%) with TJC ≥ 1, 24 (44.4%) with SJC ≥ 1, 17 (60.7%) with enthesitis, and 9 (75.0%) with dactylitis at initiation achieved resolution at 6 months (Table 1). Improvement was observed at 6 months in clinical outcomes and PROs in the overall population (Figures 1 and 2) and in patients who initiated secukinumab as a ≥ 4th-line biologic.Table 1.Resolution of Peripheral Arthritis, Enthesitis, and Dactylitis at 6 Months Among Patients With ≥ 1 Site at InitiationSecondary OutcomesInitiation,Mean (SD) [n]6-Month Follow-Up,Resolution (Count = 0), n (%)TJC (1-68)9.0 (9.7) [68]28 (41.2)SJC (1-66)4.7 (4.2) [54]24 (44.4)Enthesitis (1-6)1.9 (1.1) [28]17 (60.7)Dactylitis (1-20)2.1 (1.3) [12]9 (75.0)Conclusion:In the Corrona registry, most secukinumab initiators with PsA were biologic experienced and were not in MDA at time of initiation. Consistent with clinical trials, real-world patients treated with secukinumab achieved MDA as well as improvement in clinical manifestations, PROs, and work productivity.

Simplification of Validated Patient-Reported Outcome Instruments in Inflammatory Bowel Disease

AbstractObjectivesImproving health-related quality of life (HRQoL) is a major treatment goal for inflammatory bowel disease (IBD) patients. Tools to measure HRQoL, including the Pittsburgh Sleep Quality Index and the Short Inflammatory Bowel Diseases Questionnaire, are lengthy and rely on recall. This prospective, proof-of-concept pilot study assessed the feasibility, reliability, and validity of daily, simplified HRQoL and sleep quality data collection using mobile technologies in patients with IBD.MethodsAdult IBD patients were recruited from our center. Daily HRQoL and sleep quality were assessed using visual analog scale (VAS) surveys, and pain was assessed using the Wong-Baker FACES Pain Rating Scale (WBS). HRQoL and sleep were assessed on days 1, 14, and 28 of the study using the short IBD Questionnaire (SIBDQ) and Pittsburgh Sleep Quality Index (PSQI). Correlation between the daily instruments and the biweekly validated instruments were assessed using the Pearson correlation coefficient.ResultsOne hundred patients were enrolled. The correlation between mean global assessment VAS score over 2 weeks and PSQI score taken at 14 days was moderate (r = 0.62, P &amp;lt; 0.0001). The correlation over the same time interval between mean WBS score and SIBDQ score was strong (r = −0.71, P &amp;lt; 0.0001), and the correlation between mean sleep VAS score and PSQI score was moderate (r = −0.55, P &amp;lt; 0.0001).ConclusionsThis study demonstrates the potential for electronic quality of life, sleep quality, and pain assessments as feasible, reliable, and valid tools in IBD patients. Intermittent administration of these simplified electronic assessments may be useful in further reducing patient survey burden without significantly compromising their utility.

Validation of the Functional Assessment of Chronic Illness Therapy-Fatigue Scale in Patients with Moderately to Severely Active Systemic Lupus Erythematosus, Participating in a Clinical Trial

Fatigue is a common symptom of systemic lupus erythematosus (SLE). Our objective was to validate the 13-item Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale in patients with SLE. The FACIT-Fatigue, Medical Outcomes Study Short-Form-36 (SF-36) questionnaire, Brief Pain Inventory (BPI), and Patient Global Assessment Visual Analog Scale (Patient-GA) were completed at baseline and at Weeks 12, 24, and 52 by patients with moderately to severely active extrarenal SLE. The patients were participating in a rituximab clinical trial. The British Isles Lupus Assessment Group (BILAG) disease activity index and the Physician Global Assessment Visual Analog Scale (Physician-GA) were completed by physicians at the same visits. At baseline, 254 patients completed the FACIT-Fatigue scale. Cronbach's α was > 0.95 at all visits. In cross-sectional analyses, FACIT-Fatigue scores differentiated between groups defined by BILAG General domain ratings. FACIT-Fatigue had moderate-high correlations (r = 0.5-0.8) with SF-36, BPI, and Patient-GA, but poor correlations with BILAG total score and Physician-GA (r = 0.1-0.3). At Weeks 12, 24, and 52, mean FACIT-Fatigue scale improvement was higher in patients who improved versus those who remained unchanged on the BILAG General domain. FACIT-Fatigue scale scores remained stable for patients with worsened BILAG General domain ratings compared to baseline. Distribution and anchor-based estimates suggested a minimally important difference (MID) range of 3-6 points. The FACIT-Fatigue scale is a valid and responsive measure of fatigue in patients with SLE. MID in this SLE sample is similar to that derived previously in other populations. Since few patients experienced worsening BILAG General and Musculoskeletal domains in this study, further research is warranted to evaluate the responsiveness of FACIT-Fatigue to worsening of these domains.

The Ankylosing Spondylitis Quality of Life Questionnaire: validation in a New Zealand cohort

To examine the validity of the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) in a New Zealand population with defined axial spondyloarthritis (SpA). Once validated, the ASQoL will be included as an outcome measure in a proposed multicentre New Zealand study. Five healthy participants were interviewed to identify any issues related to local dialect or linguistic comprehension of the questionnaire. Cognitive debriefing interviews were conducted with four participants with SpA to assess the relevance and comprehensiveness of the questionnaire. Internal consistency was established by determining the Cronbach's alpha. Finally, convergent validity of the ASQoL was assessed by testing the correlation with the Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and patient global visual analogue scale (VAS) scores in a cohort of 63 SpA patients. The language used in the ASQoL was considered clear, comprehensible and accessible to speakers of New Zealand English. The questionnaire displayed content validity for patients with SpA. The ASQoL had good internal consistency in the present sample (α = 0.854). A positive correlation was found between the ASQoL and the BASFI (rho = 0.635, P < 0.001), BASDAI (rho = 0.521, P < 0.001) and patient global assessment VAS (rho = 0.546, P < 0.001), providing evidence that the ASQoL has convergent validity among patients with SpA in New Zealand. Test-retest reliability was good over 16 weeks (rho = 0.730, P < 0.001). The ASQoL has been demonstrated in this study to be feasible, internally consistent and to have content and convergent validity in a New Zealand population of patients with axial spondyloarthritis; it is a measure of quality of life which is both easy to employ and reliable.

Health‐related quality of life in multiple sclerosis: effects of natalizumab

To report the relationship between disease activity and health-related quality of life (HRQoL) in relapsing multiple sclerosis, and the impact of natalizumab. HRQoL data were available from 2,113 multiple sclerosis patients in natalizumab clinical studies. In the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM) study, patients received natalizumab 300 mg (n = 627) or placebo (n = 315); in the Safety and Efficacy of Natalizumab in Combination with Interferon Beta-1a in Patients with Relapsing Remitting Multiple Sclerosis (SENTINEL) study, patients received interferon beta-1a (IFN-beta-1a) plus natalizumab 300 mg (n = 589), or IFN-beta-1a plus placebo (n = 582). The Short Form-36 (SF-36) and a subject global assessment visual analog scale were administered at baseline and weeks 24, 52, and 104. Prespecified analyses included changes from baseline to week 104 in SF-36 and visual analog scale scores. Odds ratios for clinically meaningful improvement or worsening on the SF-36 Physical Component Summary (PCS) and Mental Component Summary were calculated. Mean baseline SF-36 scores were significantly less than the general US population and correlated with Expanded Disability Status Scale scores, sustained disability progression, relapse number, and increased volume of brain magnetic resonance imaging lesions. Natalizumab significantly improved SF-36 PCS and Mental Component Summary scores at week 104 in AFFIRM. PCS changes were significantly improved by week 24 and at all subsequent time points. Natalizumab-treated patients in both studies were more likely to experience clinically important improvement and less likely to experience clinically important deterioration on the SF-36 PCS. The visual analog scale also showed significantly improved HRQoL with natalizumab. HRQoL was impaired in relapsing multiple sclerosis patients, correlated with severity of disease as measured by neurological ratings or magnetic resonance imaging, and improved significantly with natalizumab.