Characterization of Patients With Axial Spondyloarthritis by Enthesitis Presence: Data from the Corrona Psoriatic Arthritis/Spondyloarthritis Registry.

OBJECTIVE: To compare the characteristics of patients with axial spondyloarthritis (axSpA) who had enthesitis versus those without enthesitis. METHODS: This study included adult patients with axSpA enrolled in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry (March 2013 to August 2018). Enthesitis was assessed at enrollment via the Spondyloarthritis Research Consortium of Canada Enthesitis Index. Characteristics were compared between patients with and without enthesitis using t tests or Wilcoxon rank-sum tests for continuous variables and χ RESULTS: Of 477 patients with axSpA, 121 (25.4%) had enthesitis (mean, 3.9 sites) at enrollment. Higher proportions of patients with enthesitis were female and had nonradiographic axSpA than those without enthesitis (both P \u3c 0.05). Additionally, higher proportions of patients with enthesitis had prior biologic (38.8% vs 27.2%) and conventional synthetic disease-modifying antirheumatic drug (csDMARD; 24.8% vs 13.3%) use and were currently receiving a combination of biologics and csDMARDs (28.6% vs 18.1%) than those without enthesitis. Patients with enthesitis had worse disease activity (tender and swollen joint counts, physician global assessment, Ankylosing Spondylitis Disease Activity Score, Bath Ankylosing Spondylitis Disease Activity Index, and Bath Ankylosing Spondylitis Functional Index), spinal mobility, and quality of life (pain, fatigue, Health Assessment Questionnaire, and EuroQol visual analog scale scores); greater work impairment; and had a history of depression and fibromyalgia than those without enthesitis (all P \u3c 0.05). CONCLUSION: In this US-based real-world study, enthesitis in patients with axSpA was associated with worse disease activity and quality of life than those with no enthesitis

Descriptive Comparisons of the Impact of Apremilast and Methotrexate Monotherapy in Oligoarticular Psoriatic Arthritis: the Corrona Psoriatic Arthritis/Spondyloarthritis Registry Results

OBJECTIVE: Therapeutic response was evaluated among new apremilast, methotrexate, or biologic disease-modifying anti-rheumatic drug (bDMARD) initiators with oligoarticular psoriatic arthritis (PsA). METHODS: Patients with oligoarticular PsA in the Corrona PsA/Spondyloarthritis Registry initiating treatment with apremilast, methotrexate, or bDMARD and completing 6-month follow-up were included. RESULTS: In total, 150 patients initiated monotherapy (apremilast: n=34; methotrexate: n=15; bDMARD: n=101). Apremilast initiators had higher baseline disease activity than methotrexate initiators. At follow-up, apremilast initiators experienced numerically greater disease activity improvements than methotrexate initiators and similar improvements to bDMARD initiators. CONCLUSION: Findings suggest apremilast monotherapy is an effective option for patients with oligoarticular PsA

Effectiveness of 6-Month Use of Secukinumab in Patients With Psoriatic Arthritis in the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry.

OBJECTIVE: To evaluate clinical and patient-reported outcomes (PROs) at 6 months after secukinumab initiation in US patients with psoriatic arthritis (PsA). METHODS: Patients with PsA in the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry who initiated secukinumab between April 1, 2017, and December 2, 2019, and maintained secukinumab at their 6-month follow-up visit were included. Achievement of minimal disease activity (MDA) among patients not in MDA at initiation; resolution (ie, no evidence) of tender and swollen joint counts, enthesitis, and dactylitis among patients with ≥1 of these at initiation; and change in disease activity and PROs were evaluated at 6 months in all patients and in patients who received secukinumab as a first-line biologic. RESULTS: Of 100 eligible patients included, most (83.0%) were biologic experienced and 17.0% initiated secukinumab as a first-line biologic. At initiation, 75/90 patients (83.3%) with available data were not in MDA; 26/71 (36.6%) with follow-up data achieved MDA at 6 months. Furthermore, 28/68 patients (41.2%) with ≥1 tender joint, 24/54 (44.4%) with ≥1 swollen joint, 17/28 (60.7%) with enthesitis, and 9/12 (75.0%) with dactylitis at initiation achieved resolution at 6 months. Improvements in clinical manifestations, PRO measures, and work productivity and activity were observed after 6 months among patients with PsA who initiated and maintained secukinumab. CONCLUSION: In this real-world population, patients with PsA who received and maintained secukinumab for 6 months achieved MDA in proportions consistent with clinical trials and demonstrated improvements in clinical manifestations and PROs

Evaluation of Clinical Diagnosis of Axial Psoriatic Arthritis (PsA) or Elevated Patient-reported Spine Pain in CorEvitas\u27 PsA/Spondyloarthritis Registry.

OBJECTIVE: To determine the presence of axial symptoms in patients with psoriatic arthritis (PsA) and examine differences between those with or without a diagnosis of axial PsA (axPsA). METHODS: Patients with PsA at their Corevitas\u27 (formerly Corrona) Psoriatic Arthritis/Spondyloarthritis Registry enrollment visit were stratified into 4 mutually exclusive groups based on axial manifestations: physician- diagnosed axPsA only (Dx RESULTS: Of 3393 patients included, 226 (6.7%) had Dx CONCLUSION: Patients who had self-reported elevated spine symptoms, with or without physician-diagnosed axPsA, had worse quality of life and higher disease activity overall than patients without axial manifestations, suggesting an unmet need in this patient population

Disease Characteristics, Quality of Life, and Work Productivity by Enthesitis Site: Real- World Data From the US Corrona Psoriatic Arthritis/Spondyloarthritis Registry.

OBJECTIVE: To assess the impact of clinical enthesitis by body site in patients with psoriatic arthritis (PsA). METHODS: Adults with PsA enrolled in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry (March 2013-March 2018) were included. Enthesitis at enrollment was assessed via the Spondyloarthritis Research Consortium of Canada Enthesitis Index and classified by affected sites (upper, lower, or both). Disease activity (eg, Clinical Disease Activity Index, clinical Disease Activity Index for PsA), patient-reported outcomes (PROs; eg, patient-reported pain and fatigue), and work productivity were compared between those with and without enthesitis using t or Wilcoxon rank-sum tests for continuous variables and χ2 or Fisher exact tests for categorical variables. The association of enthesitis with disease activity and PRO measures vs no enthesitis was modeled using multivariable-adjusted linear or logistic regression. RESULTS: Of 2003 patients with PsA, 391 (19.5%) had enthesitis: 80 (20.5%) in upper sites only, 137 (35.0%) in lower sites only, and 174 (44.5%) in both. Regardless of location, disease activity and PROs were worse in patients with vs without enthesitis. In adjusted models, presence of enthesitis at any site was significantly associated with worse disease activity vs no enthesitis. Enthesitis in lower or both upper and lower sites was associated with higher pain and fatigue scores and greater work impairment vs no enthesitis. CONCLUSION: Patients with clinical enthesitis had worse disease activity regardless of enthesitis location vs those without enthesitis, and patients with enthesitis in lower or both upper and lower sites had worse pain, fatigue, and work impairment

Multisite learning of high-dimensional heterogeneous data with applications to opioid use disorder study of 15,000 patients across 5 clinical sites

Integrating data across institutions can improve learning efficiency. To integrate data efficiently while protecting privacy, we propose A one-shot, summary-statistics-based, Distributed Algorithm for fitting Penalized (ADAP) regression models across multiple datasets. ADAP utilizes patient-level data from a lead site and incorporates the first-order (ADAP1) and second-order gradients (ADAP2) of the objective function from collaborating sites to construct a surrogate objective function at the lead site, where model fitting is then completed with proper regularizations applied. We evaluate the performance of the proposed method using both simulation and a real-world application to study risk factors for opioid use disorder (OUD) using 15,000 patient data from the OneFlorida Clinical Research Consortium. Our results show that ADAP performs nearly the same as the pooled estimator but achieves higher estimation accuracy and better variable selection than the local and average estimators. Moreover, ADAP2 successfully handles heterogeneity in covariate distributions

Treatment Responses in Patients With Psoriatic Arthritis Axial Disease According to Human Leukocyte Antigen-B27 Status: An Analysis From the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry.

OBJECTIVE: Axial disease is common and burdensome in patients with psoriatic arthritis (PsA). Human leukocyte antigen-B27 (HLA-B27) is a risk factor for axial PsA; treatment response by HLA-B27 status is inadequately characterized. This study evaluated responses to biologic disease-modifying antirheumatic drugs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) overall and by HLA-B27 status in patients with PsA axial disease. METHODS: This observational study included participants in the CorEvitas (formerly Corrona) PsA/Spondyloarthritis Registry who initiated bDMARD or tsDMARD treatment at baseline, had a 6-month follow-up visit, fulfilled Classification Criteria for Psoriatic Arthritis, had a baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥4, and had known HLA-B27 status. Disease characteristics at baseline and 6 months were evaluated overall and by HLA-B27 status. Association between HLA-B27 status and treatment response was evaluated using an analysis of covariance model. RESULTS: The analysis included 173 bDMARD or tsDMARD treatment initiations (54 [31.2%] among patients with HLA-B27+ status and 119 [68.8%] among patients with HLA-B27- status). BASDAI total and component scores decreased by ≤0.84 across groups after 6 months of bDMARD or tsDMARD therapy; these changes are not considered clinically meaningful. HLA-B27 status was not statistically significantly associated with changes in axial-related outcomes. CONCLUSION: In patients with PsA axial disease, 6 months of bDMARD or tsDMARD therapy provided only mild improvements in axial-related outcomes, irrespective of HLA-B27 status. This continued high disease activity reflects a critical unmet need for focus on the axial domain of PsA and for additional safe and effective therapies for psoriatic axial disease

Experiences of Patients With Rheumatic Diseases in the United States During Early Days of the COVID-19 Pandemic.

ObjectivePatients with rheumatic diseases such as rheumatoid arthritis (RA) and lupus have increased risk of infection and are treated with medications that may increase this risk yet are also hypothesized to help treat COVID-19. We set out to understand how the COVID-19 pandemic has impacted the lives of these patients in the United States.MethodsParticipants in a US-wide longitudinal observational registry responded to a supplemental COVID-19 questionnaire by e-mail on March 25, 2020, about their symptoms, COVID-19 testing, health care changes, and related experiences during the prior 2 weeks. Analysis compared responses by diagnosis, disease activity, and new onset of symptoms. Qualitative analysis was conducted on optional free-text comment fields.ResultsOf the 7061 participants invited to participate, 530 responded, with RA as the most frequent diagnosis (61%). Eleven participants met COVID-19 screening criteria, of whom two sought testing unsuccessfully. Six others sought testing, three of whom were successful, and all test results were negative. Not quite half of participants (42%) reported a change to their care in the prior 2 weeks. Qualitative analysis revealed four key themes: emotions in response to the pandemic, perceptions of risks from immunosuppressive medications, protective measures to reduce risk of COVID-19 infection, and disruptions in accessing rheumatic disease medications, including hydroxychloroquine.ConclusionAfter 2 weeks, many participants with rheumatic diseases already had important changes to their health care, with many altering medications without professional consultation or because of hydroxychloroquine shortage. As evidence accumulates on the effectiveness of potential COVID-19 treatments, effort is needed to safeguard access to established treatments for rheumatic diseases