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Introduction Anti-cyclic citrullinated peptide (anti-CCP) antibodies are associated with poor prognosis in patients with rheumatoid arthritis (RA). Previous data from randomized controlled trials and clinical practice have shown anti-CCP-positive (+) patients had a better response to treatment with abatacept or tumor necrosis factor inhibitor (TNFi) treatment than those who were anti-CCP negative. This study assessed the association between baseline anti-CCP2 [a surrogate for anti-citrullinated protein antibody (ACPA)] concentration and 6-month treatment responses to abatacept or TNFi in patients with RA. Methods This real-world analysis included biologic-experienced patients from CERTAIN (Comparative Effectiveness Registry to study Therapies for Arthritis and Inflammatory CoNditions) who initiated abatacept or TNFi, had prior biologic disease-modifying drug exposure and baseline anti-CCP2 concentration/serostatus and serum samples (baseline and 6 months). Baseline demographics and disease characteristics were compared. Change from baseline at 6 months in Clinical Disease Activity Index (CDAI) score and patient-reported outcomes [PROs: pain, fatigue, patient global assessment (PtGA), modified Health Assessment Questionnaire (mHAQ) score], by baseline anti-CCP2 quartile and binary cut-off (> 10–250 and > 250 U/ml), were evaluated separately in the abatacept and TNFi groups using a linear regression model adjusted for age, sex, CDAI/PROs, comorbidity index, and methotrexate use. Results Included were 138 abatacept and 137 TNFi initiators who were anti-CCP2+. At baseline, there were significant differences between anti-CCP2 quartiles and mean CDAI, swollen joint count 28, C-reactive protein (CRP), Disease Activity Score 28 (CRP), rheumatoid factor (RF), mHAQ and physician global assessment among abatacept initiators, and in mean RF, mHAQ, and PtGA among TNFi initiators. Among abatacept (but not TNFi) initiators, CDAI numerically improved (p = 0.208) and PROs significantly improved (p, Plain Language Summary Rheumatoid arthritis (RA) is an autoimmune disease – a disease that causes the immune system to attack an individual’s own body. A key feature of RA is the presence of proteins called autoantibodies in the blood. While antibodies help protect against external threats such as viruses, autoantibodies mistakenly target an individual’s own tissues and organs. One type of autoantibody often found in patients with RA is called anti-cyclic citrullinated peptide (anti-CCP). Studies have shown that patients with RA with anti-CCP antibodies may experience worse physical symptoms, function, disease activity, and outcomes than patients with RA without anti-CCP antibodies. Clinical trials suggest that some drugs may be more effective than others at managing symptoms of RA in patients who have anti-CCP in their blood. It is important to study this further to give doctors a sense of how patients respond to drug therapy in the ‘real world’, without clinical trial constraints. This study examined real-world patient data to see whether the presence of anti-CCP in patients’ blood impacted how their RA symptoms responded to treatment with two different drugs: abatacept or a tumor necrosis factor inhibitor (TNFi). This study found that patients with higher levels of anti-CCP at the start of the study, compared with patients with lower levels of anti-CCP, experienced less disease activity and greater improvement in physical function after 6 months of treatment with abatacept. The study found no relationship between anti-CCP and treatment response after 6 months of treatment with a TNFi. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-021-00310-2.

Introduction Generalized pustular psoriasis (GPP) is a rare, severe, and potentially life-threatening systemic and chronic autoinflammatory disease characterized by sterile, neutrophilic pustules. The standard of care for GPP varies by region, with limited information and experience of flares and their treatment. Our aim was to establish current unmet needs in GPP by better understanding the natural history of GPP, examining how dermatologists diagnose GPP and GPP flares, and establishing the range and adequacy of GPP treatment options currently prescribed by dermatologists. Methods Eligible dermatologists (N = 29) completed a 28-question structured survey, covering ten themes, ranging from GPP diagnostic criteria to GPP symptoms and treatment. Results All dermatologists stated that pustules were necessary to diagnose a GPP flare. The most frequently reported triggering factors for GPP were steroid withdrawal (64%), infection (58%), and stress (50%). Most dermatologists indicated that available treatment options for GPP flares were adequate “most” (79%) or “all” (14%) of the time. Despite this reported adequacy, 38% of dermatologists reported that it was at least “somewhat common” for a flare to require hospitalization. Furthermore, 72% of dermatologists indicated that treatments were too slow to control flares, and 66% indicated that treatments did not adequately prevent new flares at least “sometimes”. Conclusion This survey suggests that there are key features of GPP flares, and could initiate discussion around forming consensus guidelines for diagnosis and management. While the results suggest that moderately effective therapies may exist, the need for GPP-specific treatments remains. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-021-00493-0.

The objectives of this analysis were to assess the prevalence of Sjögren’s syndrome (SS) associated with rheumatoid arthritis (RA) and to compare baseline characteristics of patients with RA with and without SS. Adult patients with RA from a large observational US registry (Corrona RA), with ≥ 1 visit for assessment of SS status between 22 April 2010 and 28 February 2018, were considered. Patients with RA with versus without SS were compared. SS status was determined from a yes/no variable and reported at enrollment into the Corrona RA registry and follow-up visits. Outcomes were unadjusted prevalence of SS in patients with RA, prevalence of SS by RA disease duration, and baseline characteristics in patients with RA by SS status. Of 24,528 eligible patients, 7870 (32.1%) had a diagnosis of RA and SS. The unadjusted overall rate for SS prevalence in patients with RA was 0.30 (95% confidence interval 0.29, 0.31). SS prevalence increased with increasing RA duration. Patients with RA with versus without SS were more likely to be older, female, and seropositive; had a longer RA duration; higher disease activity; and a higher incidence of comorbidities (hypertension, cardiovascular disease, malignancies, and serious infections), erosive disease, and subcutaneous nodules at index date. Patients with RA and SS had a higher disease burden than those with RA only. The prevalence of SS increased as duration of RA increased. RA with SS was associated with seropositivity, more severe RA, extra-articular manifestations, and comorbidities.Key Points• The overall prevalence of SS among patients with RA was 30%.• The prevalence of SS increased with increasing RA disease duration.• Identifying specific clinical characteristics of patients with RA with SS, such as a greater incidence of extra-articular manifestations and comorbidities, may help clinicians to better characterize this patient population.

Biologic therapies have revolutionized the management of moderate-to-severe psoriasis; however, there are a limited number of US real-world studies characterizing patients based on response to these treatments. This study examined characteristics at enrollment and change in outcomes of US patients with moderate-to-severe psoriasis who achieved insufficient responses with ustekinumab.This study included patients enrolled in the Corrona Psoriasis Registry from April 2015 to June 2018 who initiated ustekinumab at enrollment and who were stratified based on achievement of psoriasis body surface area improving to3% or by 75% from enrollment to the 6-month follow-up visit (response vs insufficient response). Patient demographics and disease characteristics were described at enrollment, and changes in outcomes were assessed at 6-month follow-up for ustekinumab responders and insufficient responders.Of the 178 patients who initiated ustekinumab in the Corrona Psoriasis Registry and had ≥1 follow-up visit, 99 (55.6%) were classified as responders at the 6-month follow-up visit. Logistic regression modeling showed that increasing age was significantly associated with a decreased likelihood of achieving a response (OR, 0.981 [95%CI, 0.962-0.999];These findings may help dermatologists characterize patients with moderate-to-severe psoriasis who have inadequate responses to biologic treatments.

Introduction This study aimed to characterize disease burden among patients with rheumatoid arthritis (RA) with moderate-to-high disease activity who had received conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) monotherapy for ≥ 6 months but had not advanced to a biologic therapy. Methods Patients enrolled in the US Corrona RA Registry between June 1, 2014, and January 30, 2018, with 6 months of continuous csDMARD monotherapy, with moderate-to-high disease activity, who remained biologic naive, and who had ≥ 1 follow-up visit were identified. Disease activity was assessed among patients with a 6-month follow-up visit (± 3 months). Descriptive statistics were used to compare demographics and disease characteristics between patients with or without treatment advancement. Results The study included 409 patients with a disease activity assessment at 6 months (mean (SD) age 65.9 (12.6) years; mean duration of csDMARD therapy 407 (221) days). Of those patients, more than half (54%, n = 219) remained in moderate-to-high disease activity. Patients remaining in moderate-to-high vs. remission-to-low disease activity had higher baseline swollen (6.1) and tender joint counts (6.8). Over the 6-month period, treatment advancement occurred in 29% of patients. Those who advanced treatment (n = 118) vs. did not advance treatment (n = 291) were younger, had a shorter duration of RA, had higher disease activity, and reported higher levels of pain and fatigue. Conclusions The substantial number of patients with persistent moderate-to-high disease on csDMARDs over a 6-month period and who did not advance treatment indicates that there is considerable need for a treat-to-target approach to care for patients with RA. Key Points•For patients with RA and an inadequate response to treatment with initial csDMARD monotherapy, guidelines recommend treatment advancement; however, this may not be occurring in real-world clinical settings.•In the current study, a substantial proportion of patients (54%) on csDMARDs had persistent moderate-to-severe disease activity at the 6-month (± 3 months) follow-up visit; however, only 29% of patients had their medication treatment advanced, indicating that there is considerable need for a treat-to-target approach to care for patients with RA.•Patients with younger age, shorter RA duration, and higher disease activity were more likely to have their medication treatment advanced, which suggests that potentially more aggressive treatment of disease activity is needed across the whole RA population.

Objective: Biologic therapies have dramatically changed the management of moderate to severe psoriasis; however, few US real-world studies characterize the unmet needs of patients who do not respond to biologic therapies. This study examined the characteristics at enrollment of patients with moderate to severe psoriasis who had insufficient responses to anti-tumor necrosis factor therapies (anti-TNFs). Methods: Patients enrolled in the Corrona Psoriasis Registry from April 2015 to June 2018 who initiated an anti-TNF at enrollment were stratified on the basis of body surface area (BSA) improvement to

Objective.To assess longterm safety in a US cohort of patients with rheumatoid arthritis (RA) treated with adalimumab (ADA) in real-world clinical care settings.Methods.This observational study analyzed the longterm incidence of safety outcomes among patients with RA initiating ADA, using data from the Corrona RA registry. Patients were adults (≥ 18 yrs) who initiated ADA treatment between January 2008 and June 2017, and who had at least 1 followup visit.Results.In total, 2798 ADA initiators were available for analysis, with a mean age of 54.5 years, 77% female, and mean disease duration of 8.3 years. Nearly half (48%) were biologic-naive, and 9% were using prednisone ≥ 10 mg at ADA initiation. The incidence rates per 100 person-years for serious infections, congestive heart failure requiring hospitalization, malignancy (excluding nonmelanoma skin cancer), and all-cause mortality were 1.86, 0.15, 0.64, and 0.33, respectively. The incidence of serious infections was higher in the first year of therapy (3.44, 95% CI 2.45–4.84) than in subsequent years, while other measured adverse effects did not vary substantially by duration of exposure. The median time to ADA discontinuation was 11 months, while the median time to first serious infection among those experiencing a serious infection event was 12 months.Conclusion.Analysis of longterm data from this prospective real-world registry demonstrated a safety profile consistent with previous studies in patients with RA. This analysis did not identify any new safety signals associated with ADA treatment and provides guidance for physicians prescribing ADA for extended periods.

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

OBJECTIVE To identify and prioritize patient- and rheumatologist-perceived barriers to achieving disease control. METHODS Patients with rheumatoid arthritis (RA) and rheumatologists from the Corrona registry were invited by e-mail to participate in nominal groups. Two separate lists of barriers were created, 1 from RA patient-only nominal groups and the other from rheumatologist-only nominal groups, and barriers were sorted into themes. Next, using an online survey, a random sample of RA patients from the Corrona registry were asked to rank their top 3 barriers to achieving disease control. RESULTS Four nominal groups totaling 37 RA patients identified patient barriers to achieving control of RA activity that were classified into 17 themes. Three nominal groups totaling 25 rheumatologists identified barriers that were classified into 11 themes. The financial aspects of RA care ranked first for both types of nominal groups, while medication risk aversion ranked second among the perceived barriers of the physician nominal group and third among those of the RA patient nominal group. Among the 450 RA patients surveyed, 77% considered RA a top health priority, and 51% reported being aware of the treat-to-target strategy for RA care; the 3 most important patient-perceived challenges to achieving disease control were RA prognosis uncertainty, medication risk aversion, and the financial/administrative burden associated with RA care. CONCLUSION There are common, potentially modifiable, patient- and rheumatologist-reported barriers to achieving RA disease control, including perceived medication risk aversion, suboptimal treatment adherence, and suboptimal patient-physician communication regarding the benefits of tight control of disease activity in RA. Addressing these obstacles may improve adherence to goal-directed RA care.

Introduction Anti-citrullinated protein antibodies (ACPAs) are highly specific serological biomarkers that are indicative of a poor prognosis in patients with rheumatoid arthritis (RA). The effectiveness of biologic disease-modifying antirheumatic drugs (bDMARDs) with different mechanisms of action may vary, based on patients’ serostatus. The aim of this study is to compare the effectiveness of abatacept versus tumor necrosis factor inhibitors (TNFis) in patients with RA who were anti-cyclic citrullinated peptide antibody positive (anti-CCP+). Methods Abatacept or TNFi initiators with anti-CCP+ status (≥ 20 U/ml) at or prior to treatment initiation were identified from a large observational US cohort (1 December 2005–31 August 2016). Using propensity score matching (1:1), stratified by prior TNFi use (0, 1 and ≥ 2), effectiveness at 6 months after initiation was evaluated. Primary outcome was mean change in Clinical Disease Activity Index (CDAI) score. Secondary outcomes included achievement of remission (CDAI ≤ 2.8), low disease activity/remission (CDAI ≤ 10), modified American College of Rheumatology 20/50/70 responses and mean change in modified Health Assessment Questionnaire score. Results After propensity score matching, the baseline characteristics between 330 pairs of abatacept and TNFi initiators (biologic naïve, n = 97; TNFi experienced, n = 233) were well balanced with absolute value standardized differences of ≤ 0.1. Both overall, and in the biologic-naïve cohort, there were no significant differences in mean change in CDAI score at 6 months. However, in the TNFi-experienced cohort, there was a significantly greater improvement in CDAI score at 6 months with abatacept versus TNFi initiators (p = 0.033). Secondary outcomes showed similar trends. Conclusions Improvements in clinical disease activity were seen in anti-CCP+ abatacept and TNFi initiators. TNFi-experienced anti-CCP+ patients with RA had more improvement in disease activity with abatacept versus TNFis, whereas outcomes were similar between treatments in the overall population and in biologic-naïve patients. Trial Registration ClinicalTrials.gov identifier: NCT01625650. Funding This study is sponsored by Corrona, LLC and funded by Bristol-Myers Squibb. Bristol-Myers Squibb funded the publication of this manuscript. Electronic supplementary material The online version of this article (10.1007/s40744-019-0149-3) contains supplementary material, which is available to authorized users.

Introduction Controlled clinical studies have shown that the efficacy of tocilizumab (TCZ) monotherapy is superior to that of tumor necrosis factor inhibitor (TNFi) monotherapy and comparable to that of TCZ plus methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). This study compared the real-world effectiveness of TCZ monotherapy vs. TNFis plus MTX in US patients with RA. Methods TCZ-naïve patients from the Corrona RA registry with prior exposure to ≥ 1 TNFi who initiated TCZ monotherapy or TNFi + MTX were included. Outcomes included mean change in Clinical Disease Activity Index (CDAI), achievement of low disease activity (LDA; CDAI ≤ 10), achievement of modified American College of Rheumatology (mACR) 20/50 responses, and mean change in modified Health Assessment Questionnaire (mHAQ) at 6 months. Patients initiating TNFi + MTX were grouped by MTX dose (≤ 10 mg; > 10 to ≤ 15 mg; > 15 to ≤ 20 mg; > 20 mg); outcomes in each group were compared with TCZ monotherapy using trimmed populations (excluding patients outside the propensity score distribution overlap). Results Patients in all groups experienced improvement in CDAI at 6 months (mean change, − 6.9 to − 9.7), with no significant differences between the TCZ monotherapy and TNFi + MTX groups. Achievement of LDA and mACR responses at 6 months were comparable between the TCZ monotherapy and TNFi + MTX groups; overall, 26.8–38.0% of patients achieved LDA, 24.3–37.6% achieved mACR20 response and 13.2–20.8% achieved mACR50 response. The mean change in mHAQ at 6 months was − 0.1 in all groups. Conclusions In this real-world population of US patients with RA who had prior TNFi exposure, there was no evidence of a difference in the effectiveness of TCZ monotherapy compared with that of TNFi + MTX, regardless of MTX dose, at 6 months for improving RA disease activity. Funding Corrona, LLC. Plain Language Summary Plain language summary available for this article. Electronic supplementary material The online version of this article (10.1007/s40744-018-0127-1) contains supplementary material, which is available to authorized users.

Objective.To characterize patients with rheumatoid arthritis (RA) by number of poor prognostic factors (PPF: functional limitation, extraarticular disease, seropositivity, erosions) and evaluate treatment acceleration, clinical outcomes, and work status over 12 months by number of PPF.Methods.Using the Corrona RA registry (January 2005–December 2015), biologic-naive patients with diagnosed RA having 12-month (± 3 mos) followup were identified and categorized by PPF (0–1, 2, ≥ 3). Changes in medication, Clinical Disease Activity Index (CDAI), and work status (baseline–12 mos) were evaluated using linear and logistic regression models.Results.There were 3458 patients who met the selection criteria: 1489 (43.1%), 1214 (35.1%), and 755 (21.8%) had 0–1, 2, or ≥ 3 PPF, respectively. At baseline, patients with ≥ 3 PPF were older, and had longer RA duration and higher CDAI versus those with 0–1 PPF. In 0–1, 2, and ≥ 3 PPF groups, respectively, 20.9%, 23.2%, and 26.5% of patients received ≥ 1 biologic (p = 0.011). Biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) use was similar in patients with/without PPF (p = 0.57). After adjusting for baseline CDAI, mean (standard error) change in CDAI was −4.95 (0.24), −4.53 (0.27), and −2.52 (0.34) for 0–1, 2, and ≥ 3 PPF groups, respectively. More patients were working at baseline but not at 12-month followup in 2 (13.9%) and ≥ 3 (12.5%) versus 0–1 (7.3%) PPF group.Conclusion.Despite high disease activity and worse clinical outcomes, number of PPF did not significantly predict biologic/tsDMARD use. This may warrant reconsideration of the importance of PPF in treat-to-target approaches.

A treat-to-target (TTT) strategy is recommended in rheumatoid arthritis (RA). However, health care providers' adherence to TTT in clinical practice remains unclear. We examined adherence to TTT in RA at US rheumatology sites.We used baseline information from the randomized controlled Treat-to-Target in RA: Collaboration to Improve Adoption and Adherence trial, which recruited 641 patients from 46 providers practicing at 11 US sites. We obtained data on the implementation of TTT, patient covariates, provider characteristics, and site variables. We examined the implementation of TTT using 4 cardinal features: recording a disease target, recording a disease activity measure, engaging in shared decision-making, and changing treatment if not at disease target. These features were assessed across sites and providers. We calculated a TTT implementation score as the percentage of features noted. We examined the association between patient, provider, and site covariates and TTT implementation score using proportional odds models.The implementation of TTT at baseline was suboptimal: 64.3% of visits had none of the TTT components present, 33.1% had 1 component, 2.3% had 2 components, and 0.3% had all components. The implementation of TTT was significantly different across providers and sites (P0.0001 for all). In the multivariable model, we observed that more experience as a rheumatologist was associated with a higher implementation score (P = 0.01 for trend). Compared with fellows, providers with20 years of experience in practice were more likely to have more TTT components recorded (odds ratio 7.68 [95% confidence interval 1.46-40.52]).We found that adherence to a TTT strategy in RA was suboptimal, and it differed across providers and sites.

Objective To assess the feasibility and efficacy of implementing a treat‐to‐target approach versus usual care in a US‐based cohort of rheumatoid arthritis patients. Methods In this behavioral intervention trial, rheumatology practices were cluster‐randomized to provide treat‐to‐target care or usual care. Eligible patients with moderate/high disease activity (Clinical Disease Activity Index [CDAI] score >10) were followed for 12 months. Both treat‐to‐target and usual care patients were seen every 3 months. Treat‐to‐target providers were to have monthly visits with treatment acceleration at a minimum of every 3 months in patients with CDAI score >10; additional visits and treatment acceleration were at the discretion of usual care providers and patients. Coprimary end points were feasibility, assessed by rate of treatment acceleration conditional on CDAI score >10, and achievement of low disease activity (LDA; CDAI score ≤10) by an intent‐to‐treat analysis. Results A total of 14 practice sites per study arm were included (246 patients receiving treat‐to‐target and 286 receiving usual care). The groups had similar baseline demographic and clinical characteristics. Rates of treatment acceleration (treat‐to‐target 47% versus usual care 50%; odds ratio [OR] 0.92 [95% confidence interval (95% CI) 0.64, 1.34]) and achievement of LDA (treat‐to‐target 57% versus usual care 55%; OR 1.05 [95% CI 0.60, 1.84]) were similar between groups. Treat‐to‐target providers reported patient reluctance and medication lag time as common barriers to treatment acceleration. Conclusion This study is the first to examine the feasibility and efficacy of a treat‐to‐target approach in typical US rheumatology practice. Treat‐to‐target care was not associated with increased likelihood of treatment acceleration or achievement of LDA, and barriers to treatment acceleration were identified.

Implementation of a treat-to-target strategy is challenging when the patient and physician prioritize different goals. This study aimed to “translate” improvements in Clinical Disease Activity Index (CDAI) to concepts that resonate with patients (such as pain, fatigue, morning stiffness) by examining the association between changes in disease activity and patient-reported outcomes (PROs) in a national cohort of patients with rheumatoid arthritis (RA) initiating their first biologic treatment. Patients in the Corrona registry with moderate or high disease activity (M/HDA) (defined by a CDAI score > 10), prior use of at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD), 12-month follow-up, and initiating their first tumor necrosis factor inhibitor (TNFi) between 1 January 2006 through 1 November 2015 were identified. Patients were stratified on the basis of CDAI during follow-up, and changes in PROs were compared with a test of trend using CDAI-defined groups. Of 1570 patients, 37% achieved sustained remission or low disease activity (remission/LDA), 15% had improving remission/LDA, 12% had worsening M/HDA, and 35% were in sustained M/HDA during 12-month follow-up. Those in sustained remission/LDA had greater magnitude of improvement in physical functioning, pain, fatigue, morning stiffness, patient’s global assessment, and quality of life compared with patients in sustained M/HDA (p

Tocilizumab (TCZ) monotherapy has been proven as an effective treatment for rheumatoid arthritis (RA) in clinical trials. However, there are limited data available regarding the effectiveness of TCZ monotherapy in real-world clinical settings in the United States. The objective of this study was to evaluate the impact of TCZ monotherapy on disease activity and patient-reported outcomes (PROs) in a US-based observational cohort of patients with RA seen in routine clinical practice. Eligible patients had active RA, no prior use of TCZ, and initiated TCZ as monotherapy. Changes in disease activity and PROs were assessed 1 year after TCZ initiation for the overall cohort and stratified by number of prior tumor necrosis factor inhibitors (TNFis; 0, 1, or ≥2). Primary outcomes were change in Clinical Disease Activity Index (CDAI); change in patient global disease activity, pain, fatigue; and the proportions of patients with improvement in modified Health Assessment Questionnaire (mHAQ), morning stiffness, and EQ-5D. Of 255 eligible TCZ monotherapy initiators, 9.4% were TNFi naive, 36.5% had one prior TNFi, and 54.1% had ≥2 prior TNFis. Clinical and PRO measures indicated that patients were substantially impacted by their disease at baseline. The median decrease in CDAI from baseline to 1 year was 9.8 and median patient global and pain scores improved by 10 mm, indicative of clinically meaningful improvement; the median fatigue score improved by 5 mm. Approximately 26% of patients reported clinically meaningful improvement in mHAQ, 54% experienced improvement in morning stiffness, and 20% to 36% experienced improvement in EQ-5D domains (walking, self-care, usual activities, pain/discomfort, and anxiety/depression). Improvements were similar across TNFi groups. Patients with active, refractory RA who initiated TCZ monotherapy experienced improvements in both composite disease activity scores and PROs at 1 year, regardless of prior TNFi exposure. Corrona, LLC and Genentech.

Objective Treat-to-target (TTT) is an accepted paradigm for the management of rheumatoid arthritis (RA), but some evidence suggests poor adherence. The purpose of this study was to test the effects of a group-based multisite improvement learning collaborative on adherence to TTT. Methods We conducted a cluster-randomized quality-improvement trial with waitlist control across 11 rheumatology sites in the US. The intervention entailed a 9-month group-based learning collaborative that incorporated rapid-cycle improvement methods. A composite TTT implementation score was calculated as the percentage of 4 required items documented in the visit notes for each patient at 2 time points, as evaluated by trained staff. The mean change in the implementation score for TTT across all patients for the intervention sites was compared with that for the control sites after accounting for intracluster correlation using linear mixed models. Results Five sites with a total of 23 participating rheumatology providers were randomized to intervention and 6 sites with 23 participating rheumatology providers were randomized to the waitlist control. The intervention included 320 patients, and the control included 321 patients. At baseline, the mean TTT implementation score was 11% in both arms; after the 9-month intervention, the mean TTT implementation score was 57% in the intervention group and 25% in the control group (change in score of 46% for intervention and 14% for control; P = 0.004). We did not observe excessive use of resources or excessive occurrence of adverse events in the intervention arm. Conclusion A learning collaborative resulted in substantial improvements in adherence to TTT for the management of RA. This study supports the use of an educational collaborative to improve quality.

Background:The prospective, US-based, observational Corrona PsA/SpA Registry collects real-world data on patients (pts) with PsA provided by pts and their providers.Objectives:To examine trends in characteristics of pts initiating apremilast (APR) from 2014-2019 and compare characteristics of treatment-naive pts initiating APR or methotrexate (MTX).Methods:PsA pts aged ≥18 yrs enrolled in the registry who initiated APR, MTX, and/or biologics for PsA from January 2014-August 2019 were included and stratified by year of initiation (2014-2015, 2016-2017, or 2018-2019). Demographics, clinical characteristics, treatment history, disease activity, and pt-reported outcomes (PROs) were analyzed at treatment initiation. Comparisons between treatment-naive APR vs MTX initiators during the entire 2014-2019 study period were summarized descriptively.Results:1460 PsA pts initiated APR (n=238), MTX (n=178), and/or a biologic (n=1044), including treatment-naive APR (n=20) and MTX (n=99) initiators from 2014-2019. For APR initiators in the 3 successive time periods, respectively, mean disease duration was 10.5, 12.2, and 11.4 yrs, and 87.5%, 82.5%, and 68.6% of pts had prior use of csDMARDs (similar to biologic initiators: 77.9%, 77.2%, and 68.8%). Over time, lower joint, enthesitis, and dactylitis counts, composite disease activity, and PRO measures of disease burden were observed (Table). Compared with treatment-naive MTX initiators, treatment-naive APR initiators had longer duration of PsA (8.5 vs 5.5 yrs) and time since PsA diagnosis (3.3 vs 1.8 yrs). Rates of comorbidities such as hypertension (50.0% vs 37.8%), diabetes mellitus (38.9% vs 13.3%), and metabolic syndrome (33.3% vs 8.9%) were higher in treatment-naive APR vs MTX initiators. Greater proportions of treatment-naive APR initiators had high/very high disease activity according to CDAI, DAPSA, cDAPSA, PASDAS, and DAS-28 vs MTX initiators.Conclusion:In this Corrona Registry analysis, PsA pts initiating APR had lower disease burden in recent vs prior yrs, indicating use of APR earlier in the course of PsA is increasing in real-world practice. Treatment-naive APR initiators had greater disease activity and severity vs MTX initiators. Comorbidities were common at APR initiation.Table:Disease Severity and Activity, and PROs for APR Initiators in the Corrona PsA/SpA RegistryCharacteristic2014-2015n=722016-2017n=802018-2019n=86SJC (0-66), median (IQR)2.0 (4.0)1.0 (3.0)0.0 (3.0)TJC (0-68), median (IQR)5.0 (14.0)2.0 (4.0)2.0 (10.0)SPARCC enthesitis*, mean (SD)4.7 (3.0)3.8 (2.2)3.7 (3.1)Dactylitis count†, mean (SD)2.5 (2.5)2.3 (1.0)2.2 (2.3)cDAPSA category, n (%)Remission4 (7.4)8 (14.8)13 (15.9)Low disease activity12 (22.2)18 (33.3)30 (36.6)Minimal disease activity, n (%)8 (15.1)14 (26.9)21 (25.6)DAS-28 remission, n (%)5 (19.2)8 (32.0)24 (43.6)Pain VAS (0-100 mm) >15, n (%)47 (85.5)47 (83.9)60 (73.2)Pt’s Global Assessment of Arthritis VAS (0-100 mm) >20, n (%)47 (82.5)45 (77.6)54 (65.9)HAQ >0.5, n (%)39 (69.6)35 (59.3)44 (53.7)Fatigue VAS (0-100 mm), mean (SD)56.7 (25.4)49.8 (25.945.6 (31.5)Spine pain VAS (0-100 mm), mean (SD)38.8 (27.6)36.5 (29.6)28.8 (34.1)BASDAI‡, mean (SD)5.4 (2.4)4.9 (2.5)4.4 (2.6)Morning stiffness VAS (0-100 mm), mean (SD)52.8 (27.3)51.4 (28.3)48.0 (31.2)The n represents the total sample. Number of pts with data available may vary. *Among pts with enthesitis at baseline. †Among pts with dactylitis at baseline. ‡Among pts thought to have spondylitis by the investigator. IQR=interquartile range.Disclosure of Interests:Alexis Ogdie Grant/research support from: Novartis, Pfizer – grant/research support, Consultant of: AbbVie, BMS, Eli Lilly, Novartis, Pfizer, Takeda – consultant, Mei Liu Shareholder of: Corrona, LLC – shareholder at the time of study conduct, Employee of: Corrona, LLC – employment at the time of study conduct, Meghan Glynn Shareholder of: Corrona, LLC – shareholder, Grant/research support from: Pfizer – grant/research support, Employee of: Corrona, LLC – employment, Kelechi Emeanuru Employee of: Corrona, LLC – employment, Leslie Harrold Shareholder of: Corrona, LLC – shareholder, Grant/research support from: Pfizer – grant/research support, Consultant of: AbbVie, BMS, Roche – consultant, Employee of: Corrona, LLC – employment, Jennifer Mohawk Employee of: Amgen Inc. – employment; Celgene Corporation – employment at the time of study conduct, Sven Richter Employee of: Amgen Inc. – employment; Celgene Corporation – employment at the time of study conduct, Benoit Guerette Employee of: Amgen Inc. – employment; Celgene Corporation – employment at the time of study conduct, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau

The objective of this study was to compare rheumatoid arthritis (RA) disease activity and patient-reported outcomes (PROs) in a national sample of patients with RA with/without Sjögren’s syndrome (SS). Adults with RA from a large observational US registry (Corrona RA) with known SS status between 22 April 2010 and 31 July 2018 and a visit 12 (± 3) months after index date were identified (n = 36,256/52,757). SS status: determined from a yes/no variable reported at enrolment into the Corrona RA registry and follow-up visits. Index date: date that SS status was recorded (yes/no). Patients received biologic or targeted synthetic disease-modifying antirheumatic drugs as part of standard care. Patients with RA only were followed for ≥ 12 months to confirm the absence of SS. Patients were frequency- and propensity-score matched (PSM) 1:1 and stratified by disease duration and treatment response-associated variables, respectively. Clinical Disease Activity Index (CDAI) and PROs 12 months after index visit were compared in patients with and without SS. Baseline characteristics in 283 pairs of PSM patients were balanced. Mean change in CDAI score was numerically lower in patients with RA and SS than patients with RA only (8.8 vs 9.3). Reductions in PROs of pain, fatigue and stiffness were two- to threefold lower for patients with RA and SS versus RA only. Reductions in RA disease activity and RA-related PROs were lower in patients with RA and SS versus those with RA only. Our data indicate that SS adds to treatment challenges; physicians may wish to consider SS status when managing patients with RA. Electronic supplementary material The online version of this article (10.1007/s00296-020-04602-8) contains supplementary material, which is available to authorized users.

To provide guidance for the management of gout, including indications for and optimal use of urate-lowering therapy (ULT), treatment of gout flares, and lifestyle and other medication recommendations.Fifty-seven population, intervention, comparator, and outcomes questions were developed, followed by a systematic literature review, including network meta-analyses with ratings of the available evidence according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, and patient input. A group consensus process was used to compose the final recommendations and grade their strength as strong or conditional.Forty-two recommendations (including 16 strong recommendations) were generated. Strong recommendations included initiation of ULT for all patients with tophaceous gout, radiographic damage due to gout, or frequent gout flares; allopurinol as the preferred first-line ULT, including for those with moderate-to-severe chronic kidney disease (CKD; stage3); using a low starting dose of allopurinol (≤100 mg/day, and lower in CKD) or febuxostat (40 mg/day); and a treat-to-target management strategy with ULT dose titration guided by serial serum urate (SU) measurements, with an SU target of6 mg/dl. When initiating ULT, concomitant antiinflammatory prophylaxis therapy for a duration of at least 3-6 months was strongly recommended. For management of gout flares, colchicine, nonsteroidal antiinflammatory drugs, or glucocorticoids (oral, intraarticular, or intramuscular) were strongly recommended.Using GRADE methodology and informed by a consensus process based on evidence from the current literature and patient preferences, this guideline provides direction for clinicians and patients making decisions on the management of gout.

Objective: To characterize the rate of healthcare resource utilization (HCRU) between anti-cyclic citrullinated peptide (CCP; a surrogate for anti-citrullinated protein antibodies [ACPAs]) positive...

Objective Though randomized controlled trials have demonstrated relatively comparable clinical outcomes with triple therapy (methotrexate [MTX], sulfasalazine [SSZ], and hydroxychloroquine [HCQ]) compared to combination therapy (tumor necrosis factor inhibitor [TNFi] and MTX), real-world experiences comparing these strategies have not been well studied. Methods We evaluated the clinical effectiveness and effects of medication discontinuation of triple therapy with MTX/SSZ/HCQ versus combination therapy with TNFi/MTX in rheumatoid arthritis (RA) patients enrolled in the Corrona RA Drug Safety & Effectiveness Registry. Propensity score matching was used to match patients up to a ratio of 1:3 to adjust for imbalances between treatment groups, with stratification performed according to biologics-naive or biologics-exposed status of study participants. Results Patients eligible for analysis in this study included biologics-naive RA patients (3,926 who received combination therapy with TNFi/MTX and 262 who received triple therapy with MTX/SSZ/HCQ) and biologics-exposed RA patients (3,365 who received combination therapy with TNFi/MTX and 130 patients who received triple therapy with MTX/SSZ/HCQ). Before propensity score matching, numerous factors were imbalanced between the treatment groups, with triple therapy patients generally being older, having a longer disease duration of RA and lower RA disease activity, and more likely having a history of malignancy and other comorbidities. After matching, almost all (93-98%) triple therapy patients could be matched to TNFi/MTX therapy patients, and cohort characteristics were generally well balanced. Discontinuation of medication was greater in triple therapy patients referent to TNFi/MTX therapy patients (adjusted hazard ratio [HR] of 2.17 [95% confidence interval 1.63-2.88] in the biologics-naive group; adjusted HR of 1.51 [95% confidence interval 1.06-2.15] in the biologics-exposed group). At 6 months, the proportion of biologics-naive patients attaining low disease activity was significantly greater in the TNFi/MTX treatment group (49.2% in TNFi/MTX therapy patients versus 33.3% in triple therapy patients), as was the mean change in Clinical Disease Activity Index scores (-9.3 units versus -5.5 [95% confidence interval -1.5, -6.1]). Corresponding results in the biologics-exposed patients numerically favored TNFi/MTX therapy compared to triple therapy but did not reach statistical significance. Conclusion Few patients receive triple therapy with MTX/SSZ/HCQ in the US. In the present study, drug persistence and clinical effectiveness outcomes were less favorable in triple therapy patients compared to TNFi/MTX therapy patients.

Background Oligoarticular PsA accounts for ≈50% of PsA worldwide, but only a paucity of data describes disease burden among patients with this subtype. The Corrona PsA/SpA Registry, a prospective, US-based, observational cohort study, collects real-world data on characteristics and treatment of PsA patients, including those with oligoarthritis. Objectives To characterize demographics, clinical characteristics and patient-reported outcomes (PROs) at treatment initiation in biologic-naive patients with oligoarticular (≤4 swollen and ≤4 tender joints) vs. polyarticular (>4 swollen or >4 tender joints) PsA. Methods Biologic-naive patients ≥18 years of age diagnosed with PsA and enrolled in the registry who initiated apremilast, biologics and/or csDMARDs for PsA from March 2013–December 2018 were included. Data on patient demographics, disease activity, treatment history, comorbidities and PROs were analyzed at treatment initiation; comparisons between oligoarticular and polyarticular PsA patients were performed using t-tests or Wilcoxon rank-sum tests for continuous variables and chi-square tests or Fisher’s exact tests for categorical variables, as appropriate. Results 330 biologic-naive PsA patients initiating apremilast, biologics and/or csDMARDs were included (oligoarthritis: n=149; polyarthritis: n=181). Demographics and clinical characteristics were mostly similar for patients with oligoarthritis and polyarthritis, including mean age (51.6 vs. 54.3 years; P=0.068), proportion of females (51.0% vs. 59.7%; P=0.117), mean disease duration (3.0 vs. 3.1 years; P=0.789) and prior use of csDMARDs (13.4% vs. 21.0%; P=0.072). History of comorbidities was similar between the 2 groups, but the proportion of patients with fibromyalgia was higher in the polyarthritis group (2.0% vs. 8.8%; P=0.008; Table 1). Patients with oligoarthritis had lower disease activity at treatment initiation vs. those with polyarthritis based on SJC (0-66) and TJC (0-68), nail psoriasis VAS score, cDAPSA score, presence of enthesitis, SPARCC enthesitis score, presence of dactylitis and dactylitis count. More patients with oligoarthritis were classified with minimal disease activity vs. patients with polyarthritis (Table 2). Mean Pain VAS (42.6 vs. 59.8), Fatigue VAS (41.9 vs. 55.3), Patient’s Global Assessment of Disease Activity VAS (38.6 vs. 47.7) and HAQ-DI (0.7 vs. 1.0) scores were significantly lower and the proportion of patients with HAQ-DI score Conclusion This Corrona PsA/SpA Registry analysis showed similar overall disease burden and comorbidity burden in biologic-naive patients with oligoarthritis and polyarthritis. However, patients with oligoarthritis vs. polyarthritis had lower scores on disease activity and PRO measures at treatment initiation. Acknowledgement This study was sponsored by Corrona, LLC. Corrona is supported through contracted subscriptions with multiple pharmaceutical companies. The abstract was a collaborative effort between Corrona and Celgene with financial support provided by Celgene. Disclosure of Interests Alexis Ogdie Grant/research support from: (To my university) Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Consultant for: AbbVie, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly and Company, Novartis, Pfizer, and Takeda, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly, Novartis, Pfizer Inc, Takeda, Consultant for: Abbvie, Amgen, BMS, Celgene, Corrona, Lilly, Novartis, Pfizer, Takeda, Consultant for: Abbvie, Amgen, BMS, Celgene, Corrona, Lilly, Novartis, Pfizer, Takeda, Mei Liu Employee of: M. Liu is an employee of Corrona, LLC., Meghan Glynn Employee of: M. Glynn is an employee of Corrona, LLC., Kelechi Emeanuru Employee of: Corrona, LLC, Leslie Harrold Shareholder of: Corrona, Grant/research support from: Pfizer, Consultant for: AbbVie, BMS, and Genentech, Employee of: Corrona, Sven Richter Employee of: Celgene Corporation, Benoit Guerette Employee of: Celgene Corporation, Philip J Mease Grant/research support from: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Consultant for: AbbVie, Amgen, BMS, Galapagos, Gilead Sciences, Inc., Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer and UCB

Background Therapeutic effectiveness has rarely been studied in a subpopulation of patients with oligoarticular PsA. Objectives To examine baseline characteristics and 6-month clinical assessments of PsA patients with oligoarthritis (≤4 swollen joints) who initiated apremilast (APR) or methotrexate (MTX) monotherapy in the Corrona PsA/SpA Registry, a prospective, US-based, observational cohort study. Patients initiating bDMARD monotherapy were also examined as a point of reference. Methods Patients ≥18 years of age with PsA and oligoarthritis in the registry who initiated APR, MTX or a bDMARD (reference group) monotherapy and had a 6-month follow-up visit between June 2014 and March 2018 were included. Descriptive statistics were calculated for patients’ clinical characteristics and disease assessments at treatment initiation and at the 6-month follow-up visit. Results The analysis included 150 patients initiating therapy (APR: n=34; MTX: n=15; bDMARD: n=101). Among APR and MTX initiators, 79% and 20% received at least 1 prior bDMARD, respectively. APR initiators, compared with MTX initiators, were younger (mean [SD]: 55.7 [12.6] vs. 61.5 [16.6] years), had longer disease duration (mean [SD]: 8.0 [6.7] vs. 5.4 [7.8] years), and had higher levels of disease activity at baseline, including greater skin involvement (mean body surface area affected [SD]: 7.1% [17.6%] vs. 4.8% [9.4%]), swollen joint count (mean [SD]: 1.5 [1.5] vs. 1.0 [1.1]) and Clinical Disease Activity for Psoriatic Arthritis (cDAPSA) moderate and high disease activity (50% [APR] vs. 27% [MTX]; mean score [SD]: 14.0 [8.5] vs. 11.5 [4.9]). APR initiators also had greater disease impairments at baseline, represented by numerically higher scores on patient-reported outcome (PRO) measures, including the Health Assessment Questionnaire-Disability Index (HAQ-DI; mean [SD]: 1.0 [0.7] vs. 0.5 [0.4]), Patient’s Global Assessment of Disease Activity–Psoriasis (PtGA-PsO; mean [SD]: 47.1 [29.4] vs. 28.4 [16.6]); Patient’s Global Assessment of Disease Activity–Psoriatic Arthritis (PtGA-PsA; mean [SD]: 47.1 [29.8] vs. 32.5 [26.3]), fatigue (mean [SD]: 55.9 [30.0] vs. 37.8 [31.9]) and overall pain (mean [SD]: 50.5 [31.1] vs. 46.7 [26.5]). Taken together, results suggest that APR initiators had more refractory oligoarthritis compared with MTX initiators. Clinical assessments at the 6-month follow-up indicate that patients who initiated APR experienced numerically higher improvements in disease activity and various PRO measures compared with MTX, as well as achievement of ≤1 swollen joint, HAQ-DI minimal clinically important difference and cDAPSA remission or low disease activity (Table). Of note, results associated with bDMARDs were more comparable to that of APR. Conclusion In this analysis of the Corrona PsA/SpA Registry, APR monotherapy was more often used in patients with refractory oligoarthritis compared with MTX monotherapy. Despite this, the APR treatment group experienced numerically greater improvements in disease activity measures. Improvements observed with APR treatment in patients with long-standing disease and refractory oligoarthritis were comparable to that of bDMARDs. Acknowledgement This study was sponsored by Corrona, LLC. Corrona is supported through contracted subscriptions with multiple pharmaceutical companies. The abstract was a collaborative effort between Corrona and Celgene Corporation with financial support provided by Celgene. Disclosure of Interests Alexis Ogdie Grant/research support from: (To my university) Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Consultant for: AbbVie, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly and Company, Novartis, Pfizer, and Takeda, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly, Novartis, Pfizer Inc, Takeda, Consultant for: Abbvie, Amgen, BMS, Celgene, Corrona, Lilly, Novartis, Pfizer, Takeda, Consultant for: Abbvie, Amgen, BMS, Celgene, Corrona, Lilly, Novartis, Pfizer, Takeda, Mei Liu Employee of: M. Liu is an employee of Corrona, LLC., Meghan Glynn Employee of: M. Glynn is an employee of Corrona, LLC., Kelechi Emeanuru Employee of: Corrona, LLC, Leslie Harrold Shareholder of: Corrona, Grant/research support from: Pfizer, Consultant for: AbbVie, BMS, and Genentech, Employee of: Corrona, Sven Richter Employee of: Celgene Corporation, Benoit Guerette Employee of: Celgene Corporation, Philip J Mease Grant/research support from: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Consultant for: AbbVie, Amgen, BMS, Galapagos, Gilead Sciences, Inc., Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer and UCB

Background Methotrexate (MTX) is one of the most commonly used drugs in the treatment of rheumatoid arthritis (RA). Some patients may discontinue MTX therapy due to lack of efficacy or intolerance and may or may not restart MTX. There is a need to better understand the patterns of MTX use, the characteristics of these patients, and how the patterns of use are related to outcomes. Objectives To assess patterns of MTX use in a clinical practice setting, describe baseline demographic and clinical characteristics for groups defined by patterns of MTX use, and assess the association of patterns of MTX use with clinical outcomes and side effects during the 2 years after MTX initiation. Methods This observational study included patients from the US Corrona RA registry who initiated MTX from 01 October 2001 to 31 October 2018, were biologic/targeted synthetic disease-modifying antirheumatic drug (bDMARD/tsDMARD)–naive and did not start bDMARD/tsDMARD through 2 years of follow-up. Patients were divided into 3 cohorts: those who discontinued and restarted MTX, those who discontinued without restarting MTX and those who persisted on MTX. Descriptive statistics were used to evaluate patient demographics and disease activity at MTX initiation and side effects during follow-up. Changes in clinical outcomes from baseline to 2 years were calculated for all groups. Differences in outcomes were assessed using Kruskal-Wallis one-way analysis of variance for continuous or ordinal-dependent variables and chi-square test for categorical variables. Results Among 785 MTX initiators, 34 (4.3%) discontinued/restarted MTX, 174 (22.2%) discontinued MTX, and 577 (73.5%) persisted on MTX within the 2-year follow-up period. Overall, mean age was 59.7 years; 72.7% were female; mean duration of RA was 4.8 years; and 52.9% were conventional synthetic DMARD–naive. Generally, in patients who discontinued/restarted, discontinued, or persisted on MTX, those who discontinued/restarted therapy had more comorbidities at MTX initiation: hypertension (35.3%, 32.8%, or 29.3%, respectively), malignancy (14.7%, 9.2%, or 8.7%, respectively), chronic obstructive pulmonary disease (10.0%, 3.9%, 1.9%, respectively), or asthma (5.0%, 4.7%, or 2.9%, respectively). At end of follow-up, mean Clinical Disease Activity Index (CDAI) was 15.6, 10.1, and 8.8 for those who discontinued/restarted, discontinued, and persisted, respectively. Disease activity according to CDAI improved during the 2-year follow-up for all 3 groups, but less improvement was observed in those who discontinued/restarted MTX (Table). Overall, the most common side effects while on MTX therapy were elevated liver enzymes (65.4%) and fatigue (43.1%). Patients who discontinued/restarted MTX vs those who persisted had higher rates of hair loss (35.3% vs 18.9%), loss of appetite (32.4% vs 17.3%) stomach pain (26.5% vs 14.6%), mouth sores (20.6% vs 16.3%), diarrhœa (11.8% vs 9.5%), and myelosuppression (8.8% vs 2.1%). Conclusion More than 26% of patients who initiated MTX therapy either discontinued and did not restart or discontinued and restarted therapy during 2 years of follow-up. Patients who discontinued/restarted MTX therapy had less improvement in disease activity, experienced more side effects, and tended to have more comorbidities at MTX initiation than those who persisted on therapy. Acknowledgement This study was sponsored by Corrona, LLC. Corrona is supported through contracted subscriptions with multiple pharmaceutical companies. The abstract was a collaborative effort between Corrona and AbbVie with financial support provided by AbbVie. Disclosure of Interests Leslie Harrold Shareholder of: Corrona, Grant/research support from: Pfizer, Consultant for: AbbVie, BMS, and Genentech, Employee of: Corrona, Heather J. Litman: None declared, Jacqueline O’Brien Employee of: Corrona, Hua Feng Employee of: Corrona, Casey Schlacher Shareholder of: AbbVie, Employee of: AbbVie, Namita Tundia Shareholder of: AbbVie, Employee of: AbbVie

Background: Controlling disease activity in RA using a treat-to-target (T2T) strategy can optimize clinical and patient-important outcomes. Yet, many patients are not familiar with T2T and report medication risk aversion as a major barrier to changing therapy. Objectives: To develop and evaluate an educational, direct-to-patient video intervention aimed at improving willingness of patients to appropriately escalate treatment in RA. Methods: We conducted a controlled, randomized trial of our intervention among US patients with self-reported RA enrolled in the ArthritisPower patient registry. We recruited participants by email, and surveyed their satisfaction with disease control, values about RA medications, decisional conflict and willingness to change treatment if/when recommended by their rheumatologist. Intervention group participants were invited to view up to 6 videos (3 required) relevant to T2T; those in the control group viewed 2 vaccination-related videos unrelated to T2T as an “attention control”. The primary outcome, collected using surveys, was patient-reported willingness to change RA treatment, measured by the choice predisposition scale (0-10, anchors: “Not willing at all”; “Extremely willing”) that reflected preference for RA treatment change. We compared the difference in pre-post differences in willingness to change RA treatment between the two groups using t-test. Results: We invited 1264 RA patients by email. We reached our enrollment goal in 8 weeks. Study participants (N=208) were 90% Caucasian, 90% women, with mean (SD) age 50 (11) years, in good health (51%); 52% reported familiarity with T2T. A majority (89%) reported having values that favored RA medications. We observed no differences in baseline sociodemographics, patient global assessment of disease activity, health literacy, willingness to change treatment, or decisional conflict. We found a significant improvement in pre-post willingness to change treatment in intervention vs. control participants (0.5 vs 0.01, p=0.01). We calculated an effect size (Glass’s delta) for the intervention of 0.48 (i.e. moderate). Moreover, decisional conflict about treatment change decreased; there was no significant difference in pre-post differences in decision conflict between groups. Conclusion: This randomized trial testing a novel patient-directed intervention advocating for T2T strategy implementation in RA care increased self-reported willingness to change RA treatment. Further studies are needed to evaluate if this effect is sustained over time and if it translates into actionable behavior change. Disclosure of Interests: Maria Danila Grant/research support from: Pfizer, Inc., Consultant for: Sanofi Genzyme & Regeneron, Lang Chen: None declared, Justin Owensby: None declared, Ronan O’Beirne Grant/research support from: Pfizer, Inc., Josh Melnick: None declared, Eric Ruderman Consultant for: Pfizer Inc., Leslie Harrold Shareholder of: Corrona, Grant/research support from: Pfizer, Consultant for: AbbVie, BMS, and Genentech, Employee of: Corrona, Jeffrey Curtis: None declared

Background Psoriatic arthritis (PsA) is a chronic inflammatory arthropathy typically associated with psoriasis. Little is known regarding the pattern of advanced therapy use, such as biologics and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), and how the characteristics of patients with PsA initiating these therapies differ by line of therapy. Objectives To characterise the prescribing frequency of medication classes and compare characteristics across line of therapy groups among patients with PsA who initiated a biologic/tsDMARD. Methods This observational study included patients with PsA in the US Corrona PsA/SpA Registry who initiated a biologic/tsDMARD between 31 March 2013 and 31 October 2018. Patients were grouped by line of therapy at time of drug initiation: 1st, 2nd, 3rd, or 4th-or-higher. For each group, frequencies of medication classes were calculated, and proportions (categorical variables) and means with standard deviations (continuous variables) were determined for patient demographic, clinical and disease activity characteristics, patient-reported outcome measures, history of medication use, and concomitant medication use at the time of therapy initiation. Comparisons across groups were made with chi-square tests and one-way analysis of variance. Results Data from 1516 initiators (396 (26%), 453 (30%), 333 (22%), 334 (22%) in the 1st, 2nd, 3rd, or 4th-or-higher line groups, respectively) were examined. Mean age was 53.1 years, mean time since PsA diagnosis was 8.1 years and mean time from PsA diagnosis to 1st line therapy initiation was 5.2 years. TNFi therapy was commonly initiated earlier, while initiation of the other classes as a proportion of total line-specific initiations increased in later lines of therapy (TNFi: 77%, 61%, 41%, and 30%; tsDMARDs: 16%, 18%, 19%, and 22%; IL-17: 4%, 12%, 25%, and 34%; non-TNFi/non-IL-17: 3%, 8%, 14%, and 14% for the 1st, 2nd, 3rd, and 4th-or-higher lines of therapy, respectively). Among all initiators, 72% had a history of methotrexate (MTX) use and 35% had concomitant MTX use at drug initiation. Most patients had moderate to high disease activity at therapy initiation based on the proportion of patients reporting minimal disease activity (20%) (Table); 30% had enthesitis and 15% had dactylitis. Across therapy lines, statistically significant differences in minimal disease activity, HAQ, fatigue, pain and morning stiffness (P Conclusion Patients with PsA who initiated biologic/tsDMARD therapies in a large, national US based registry frequently exhibited significant disease activity, as demonstrated by patient-reported outcome measures and validated disease activity measures. On average, disease activity was worse in later lines of therapy. Enthesitis and dactylitis were highly prevalent in this population. TNFi was the most common 1st line therapy while newer agents such as IL-17 inhibitors were most commonly initiated as 4th line therapy or higher. In light of the newly published guidelines, it appears that rheumatologists are treating in a manner aligned with the guidelines based on the characteristics of patients observed across the different lines of therapy. Acknowledgement This study was sponsored by Corrona, LLC. Corrona is supported through contracted subscriptions with multiple pharmaceutical companies. The abstract was a collaborative effort between Corrona and AbbVie with financial support provided by AbbVie. Disclosure of Interests Leslie Harrold Shareholder of: Corrona, Grant/research support from: Pfizer, Consultant for: AbbVie, BMS, and Genentech, Employee of: Corrona, Pankaj Patel Shareholder of: AbbVie, Employee of: AbbVie, Patrick Zueger Shareholder of: AbbVie, Employee of: AbbVie, Jacqueline O’Brien Employee of: Corrona, Heather J. Litman: None declared, Hua Feng Employee of: Corrona, Robert McLean: None declared

Background For RA patients (pts), EULAR and ACR recommend various DMARDs. Available treatments have short durability and low persistency. Understanding differences between patients who initiate DMARDs as biologic naive vs experienced may help clinicians tailor treatment decisions to pts needs. Objectives This study aimed to compare DMARD initiation events in biologic naive vs experienced pts. Methods In the Corrona registry (as of 2/28/2018), we selected DMARD initiation events (with at least one 6-month follow up) and stratified them on whether the initiator was biologic naive or experienced. We compared pts baseline characteristics (demographic, clinical, treatment) between strata. We used Kaplan-Meier curves to describe time to discontinuation and log rank test to assess differences in persistence. Results For 48,246 RA pts, 10,347 DMARD initiations (index date, baseline; on 11/2012 or thereafter) in 6,858 adults were identified. Within initiations, 38% (n=3,931) occurred in bDMARD naive pts. Females comprised 76% (naive) vs 80% (experienced). Despite comparable age and retirement status (Table), the bDMARD experienced initiators had RA for longer (mean: 12.6 vs 5.4), were more likely to be disabled (19.6% vs 11.0%), had marginally higher CDAI scores (mean: 19.1 vs 17.6), were more likely to discontinue index treatment due to elevated CDAI (15.5% vs 10.9%), and had a shorter treatment duration (mean: 13.8 vs 15.1 months) than bDMARD naive initiators. Persistency was higher in the bDMARD naive than in experienced initiators (Figure) Conclusion The marked difference in RA duration and pts disability status, despite comparable age, confirms prior reports that bDMARD experienced pts do not respond as well to therapy as bDMARD naive pts. The increased CDAI scores and shortened durability of response suggests that there is still a need for new efficacious and well-tolerated RA therapy. Acknowledgement Study sponsored by Corrona, LLC. Corrona is supported by contracted subscriptions with multiple companies. Abstract was a collaboration between Corrona and Gilead with financial support by Gilead. Disclosure of Interests Robin K Dore Grant/research support from: Gilead Sciences, AbbVie, Amgen, Lilly, Pfizer, Regeneron, Sanofi, Consultant for: AbbVie, Amgen, Lilly, Speakers bureau: AbbVie, Amgen, Lilly, Sanofi, Regeneron, Pfizer, UCB, Leslie Harrold Grant/research support from: Pfizer, Consultant for: AbbVie, BMS, Genentech, Taylor Blachley Employee of: Corrona, LLC, Kelechi Emeanuru Employee of: Corrona, LLC, Jenya Antonova Shareholder of: Gilead Sciences, Employee of: Eli Lilly and Company, Medimmune, Genentech, Gilead Sciences, Joel Kremer Grant/research support from: AbbVie, Genentech, Lilly, Novartis, Pfizer, Consultant for: AbbVie, Amgen, BMS, Genentech, Lilly, Regeneron, Sanofi, Pfizer

Background Sjogren’s syndrome (SS) is known to occur secondary to RA diagnosis, but its impact on RA outcomes is poorly understood. In the US-based Corrona registry, SS has a prevalence rate of 0.30 in patients (pts) with RA.1 Objectives To compare disease activity and patient-reported outcomes (PROs) in pts with and without SS, in a national sample of pts with RA. Methods We identified adult pts with rheumatologist-diagnosed RA from a large observational US registry (Corrona RA), with at least one visit with known SS status between 22 Apr 2010 and 31 Jul 2018 and a visit 12 (±3) months after index date. SS status was captured using physician forms at enrollment and follow-up visits. The index date was the date of first capture of SS diagnosis, or first visit in which SS status was recorded for pts without a diagnosis of SS (non-SS pts). Both those with and without SS were required to have initiated a targeted synthetic (ts) or biologic (b)DMARD. Non-SS pts had to be enrolled for ≥12 months. Pts were frequency matched 1:1 based on RA duration prior to 1:1 propensity score matching (PSM) based on variables associated with treatment response. Outcomes 12 months after index visit were compared in pts with and without SS. Primary outcome was mean change in CDAI score from index visit to Month 12; secondary outcome was mean change in PROs (pain, fatigue, pt global assessment and morning stiffness). Results After PSM, baseline characteristics in 283 pairs of pts with and without SS were well balanced (Table 1). Mean change in CDAI score was numerically lower in SS than non-SS pts (8.8 vs 9.3; Table 2), but this did not reach statistical significance. Improvements in pain, fatigue and stiffness were 2–2.5-fold greater for non-SS than SS pts (Table 2). Conclusion Among those initiating b/tsDMARD treatment, improvements in RA-related PROs were lower in pts with RA with SS than non-SS pts. Physicians may want to consider SS status secondary to RA when managing pts with RA and specifically explore whether additional intervention is needed to improve the pt experience for pts with RA. References [1] Harrold LR, et al. Arthritis Rheumatol. 2018;70(suppl 10): abstract 541. Acknowledgement This study was sponsored by Corrona, LLC. Corrona is supported through contracted subscriptions with multiple pharmaceutical companies. The abstract was a collaborative effort between Corrona and Bristol-Myers Squibb (BMS) with financial support provided by BMS. Professional medical writing: Lola Parfitt, MRes, Caudex; funding: BMS Disclosure of Interests Leslie R Harrold Shareholder of: Corrona LLC, Grant/research support from: Grant funding: Pfizer, Consultant for: AbbVie, Bristol-Myers Squibb, Genentech, Employee of: Corrona LLC, Ying Shan Employee of: Corrona LLC, Sabrina Rebello Employee of: Corrona, LLC, Neil Kramer Shareholder of: Johnson & Johnson, Pfizer, Regeneron, AbbVie, Amgen, Sean Connolly Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Evo Alemao Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Sheila Kelly Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Joel Kremer Grant/research support from: AbbVie, Genentech, Lilly, Novartis, Pfizer, Consultant for: AbbVie, Amgen, BMS, Genentech, Lilly, Regeneron, Sanofi, Pfizer, Elliot D Rosenstein Grant/research support from: AbbVie, Novartis, Consultant for: Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Speakers bureau: Amgen, Bristol-Myers Squibb

Introduction Treat to target guidelines recommend achieving remission or low disease activity in rheumatoid arthritis (RA). However, the reduction in adverse events and costs associated with lower disease activity is unclear. Methods We used Corrona linked to Medicare data to identify RA patients. Time varying disease activity was measured using Clinical Disease Activity Index (CDAI); outcomes included all-cause hospitalization, a composite of hospitalization or emergency department (ED) visits, mortality, and medical costs. Outcome-specific Cox proportional models evaluated the adjusted hazard ratios between disease activity and outcomes, controlling for potential confounders including comorbidities grouped into four patient phenotypes. Costs were analyzed with mixed models using a Gaussian distribution with log transformation. Results Depending on outcome, 4593 RA patients contributed up to 12 001 person years. Median age was 71 years, 75% women. At baseline, approximately 50–60% of patients were in remission or low disease activity. There was a dose-response relationship between RA disease activity (remission, low, moderate, and high) and the incidence of hospitalizations (13.1, 17.8, 21.2, 27.5 per 100 py, respectively); all adjusted hazard ratios were significant: 0.68 (remission), 0.87 (low), and 1.24 (high) compared with moderate disease activity. Similar trends were observed for ED visits and mortality. The crude difference in annual medical costs between remission ($11 145) and moderate disease activity ($17 646) was $−6 500; the adjusted difference (95%CI) was $−3133 (−4737.72, −1528.43). Conclusion Leveraging the benefits of linking registry and administrative data together, lower disease activity in RA was associated with incrementally reduced risks of all-cause hospitalization, ED visits, mortality, and medical costs in a dose-dependent fashion. Copyright © 2016 John Wiley & Sons, Ltd.

Objective To assess whether the time between the last rituximab infusion and initiation of a different biologic agent influenced infection risk in patients with rheumatoid arthritis (RA). Methods Patients with RA who newly initiated rituximab within the Consortium of Rheumatology Researchers of North America registry were included if they switched to a nonrituximab biologic agent and had ≥1 followup visit within 12 months of switching. Patients were categorized by duration of time between their last rituximab infusion and initiation of a subsequent biologic agent (≤5 months, 6–11 months, and ≥12 months). The primary outcome was time to first infectious event. Adjusted Cox regression models estimated the association between time to starting a subsequent biologic agent and infection. Results A total of 44 overall infections (7 serious, 37 nonserious) were reported during the 12-month followup in the 215 patients included in this analysis (104 switched at ≤5 months, 67 at 6–11 months, and 44 at ≥12 months). Median (interquartile range) time to infection was 4 (2–5) months. Infection rates per patient-year in the ≤5-month, 6–11-month, and ≥12-month groups were 0.34 (95% confidence interval [95% CI] 0.22–0.52), 0.30 (95% CI 0.17–0.52), and 0.41 (95% CI 0.22–0.77), respectively. After adjustment, time to switch to a subsequent biologic agent was not associated with infection, which remained unchanged when number and rate of rituximab retreatments were included in the models. Conclusion In this real-world cohort of patients with RA, infection rates ranged from 0.30 to 0.41 per patient-year, with no significant difference in the rate between patients who initiated a subsequent biologic agent earlier versus later after rituximab treatment.

Determine healthcare resource utilization (HCRU) in biologic-naïve initiators of TNF inhibitors (TNFis) associated with their disease activity from a national cohort of rheumatoid arthritis (RA) patients.RA patients were identified at their first TNFi initiation (index date) in the Corrona registry. Patients with age of RA onset18, comorbid psoriasis/psoriatic arthritis, fibromyalgia, or osteoarthritis were excluded. Patients were categorized into disease activity (DA) strata by the lowest level of DA (and sustaining low levels for at least two visits) using the Clinical Disease Activity Index (CDAI) across all visits in Corrona while on a TNFi during 1 year after initiation. Rates of all-cause and RA-related hospitalizations, rheumatologist visits, and joint surgeries while on TNFi therapy were reported and compared across DA levels along with the incidence rate ratio (IRR) adjusted for age, gender, and RA duration using Poisson mixed models.Of 1931 RA patients: 15% achieved sustained remission, 22% remission, 14% sustained low DA, 23% low DA and 27% moderate/high DA (M/HDA). Those in M/HDA had statistically higher rates of hospitalizations (37.3 per 100 patient years (py), 95% CI: 31.6-43.7 and joint surgeries (20.8 per 100 py, 95% CI: 16.6-25.8) compared to the sustained remission cohort, resulting in respective IRRs of 2.3 (p 0.001) and 1.7 (p = 0.046).Many biologic naïve RA patients initiating TNFi failed to achieve sustained remission during a 1 year period while remaining on TNFi therapy. Patients in higher DA levels had higher HCRU rates vs. patients in sustained remission, suggesting that achieving treat-to-target goals would reduce health care expenses.

Background/purpose Treat-to-target (TTT) is a recommended strategy in the management of rheumatoid arthritis (RA), but various data sources suggest that its uptake in routine care in the US is suboptimal. Herein, we describe the design of a randomized controlled trial of a Learning Collaborative to facilitate implementation of TTT. Methods We recruited 11 rheumatology sites from across the US and randomized them into the following two groups: one received the Learning Collaborative intervention in Phase 1 (month 1–9) and the second formed a wait-list control group to receive the intervention in Phase 2 (months 10–18). The Learning Collaborative intervention was designed using the Model for Improvement, consisting of a Change Package with corresponding principles and action phases. Phase 1 intervention practices had nine learning sessions, collaborated using a web-based tool, and shared results of plan–do–study–act cycles and monthly improvement metrics collected at each practice. The wait-list control group sites had no intervention during Phase 1. The primary trial outcome is the implementation of TTT as measured by chart review, comparing the differences from baseline to end of Phase 1, between intervention and control sites. Results All intervention sites remained engaged in the Learning Collaborative throughout Phase 1, with a total of 38 providers participating. The primary trial outcome measures are currently being collected by the study team through medical record review. Conclusions If the Learning Collaborative is an effective means for improving implementation of TTT, this strategy could serve as a way of implementing disseminating TTT more widely.

Background and Objectives Characterized by sudden onset of severe joint pain, swelling, redness, and tenderness to touch, gout ‘flare ups’ have a substantial impact on quality of life (QoL). This research employed a patient-centered approach to explore the symptoms and impacts of gout, and assess the content validity of existing patient-reported outcomes (PROs). Methods Qualitative interviews were conducted with 30 US gout patients (non-tophaceous: n = 20, tophaceous: n = 10) and five expert rheumatologists. Each interview included both concept elicitation (CE) questioning to learn about the patient experience and cognitive debriefing to assess the content validity of three PRO instruments (HAQ-DI, GAQ, and TIQ-20). Nine of the patients provided further real-time qualitative data through a smart phone application. All qualitative data were subject to thematic analysis using Atlas.ti. Two patient advisors and three expert clinicians were engaged as advisors at key stages throughout the research. Results Interview and real-time data identified the same core symptoms and proximal impact concepts. Severe pain (typically in joints of extremities) was described as the cardinal symptom, often accompanied by swelling, redness, heat, sensitivity to touch, and stiffness. Domains of QoL impacted included physical functioning, sleep, daily activities, and work. The PRO instruments were generally well-understood by patients, but each included items with questionable relevance to at least some of the sample, dependent on the specific joints affected. Conclusions Gout patients experience severe pain in affected joints, resulting in substantial limitations in physical functioning. Both the HAQ-DI and the TIQ-20 are useful for specific research purposes in the gout population, although modifications are recommended. Electronic supplementary material The online version of this article (doi:10.1007/s40271-016-0184-x) contains supplementary material, which is available to authorized users.

Author(s): de Lautour, Hugh; Taylor, William J; Adebajo, Ade; Alten, Rieke; Burgos-Vargas, Ruben; Chapman, Peter; Cimmino, Marco A; da Rocha Castelar Pinheiro, Geraldo; Day, Ric; Harrold, Leslie R; Helliwell, Philip; Janssen, Matthijs; Kerr, Gail; Kavanaugh, Arthur; Khanna, Dinesh; Khanna, Puja P; Lin, Chingtsai; Louthrenoo, Worawit; McCarthy, Geraldine; Vazquez-Mellado, Janitzia; Mikuls, Ted R; Neogi, Tuhina; Ogdie, Alexis; Perez-Ruiz, Fernando; Schlesinger, Naomi; Ralph Schumacher, H; Scire, Carlo A; Singh, Jasvinder A; Sivera, Francisca; Slot, Ole; Stamp, Lisa K; Tausche, Anne-Kathrin; Terkeltaub, Robert; Uhlig, Till; van de Laar, Mart; White, Douglas; Yamanaka, Hisashi; Zeng, Xuejun; Dalbeth, Nicola | Abstract: To establish consensus for potential remission criteria to use in clinical trials of gout.Experts (n = 88) in gout from multiple countries were invited to participate in a web-based questionnaire study. Three rounds of Delphi consensus exercises were conducted using SurveyMonkey, followed by a discrete-choice experiment using 1000Minds software. The exercises focused on identifying domains, definitions for each domain, and the timeframe over which remission should be defined.There were 49 respondents (56% response) to the initial survey, with subsequent response rates ranging from 57% to 90%. Consensus was reached for the inclusion of serum urate (98% agreement), flares (96%), tophi (92%), pain (83%), and patient global assessment of disease activity (93%) as measurement domains in remission criteria. Consensus was also reached for domain definitions, including serum urate (l0.36 mm), pain (l2 on a 10-point scale), and patient global assessment (l2 on a 10-point scale), all of which should be measured at least twice over a set time interval. Consensus was not achieved in the Delphi exercise for the timeframe for remission, with equal responses for 6 months (51%) and 1 year (49%). In the discrete-choice experiment, there was a preference towards 12 months as a timeframe for remission.These consensus exercises have identified domains and provisional definitions for gout remission criteria. Based on the results of these exercises, preliminary remission criteria are proposed with domains of serum urate, acute flares, tophus, pain, and patient global assessment. These preliminary criteria now require testing in clinical data sets.

OBJECTIVE: The language currently used to describe gout lacks standardisation. The aim of this project was to develop a consensus statement on the labels and definitions used to describe the basic disease elements of gout. METHODS: Experts in gout (n=130) were invited to participate in a Delphi exercise and face-to-face consensus meeting to reach consensus on the labelling and definitions for the basic disease elements of gout. Disease elements and labels in current use were derived from a content analysis of the contemporary medical literature, and the results of this analysis were used for item selection in the Delphi exercise and face-to-face consensus meeting. RESULTS: There were 51 respondents to the Delphi exercise and 30 attendees at the face-to-face meeting. Consensus agreement (≥80%) was achieved for the labels of eight disease elements through the Delphi exercise; the remaining three labels reached consensus agreement through the face-to-face consensus meeting. The agreed labels were: monosodium urate crystals, urate, hyperuric(a)emia, tophus, subcutaneous tophus, gout flare, intercritical gout, chronic gouty arthritis, imaging evidence of monosodium urate crystal deposition, gouty bone erosion and podagra. The face-to-face meeting achieved consensus agreement for the definitions of all 11 elements and a recommendation that the label 'chronic gout' should not be used. CONCLUSION: Consensus agreement was achieved for the labels and definitions of 11 elements representing the fundamental components of gout aetiology, pathophysiology and clinical presentation. The Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN) recommends the use of these labels when describing the basic disease elements of gout. This article is protected by copyright. All rights reserved.

ObjectiveThere is a lack of standardisation in the terminology used to describe gout. The aim of this project was to develop a consensus statement describing the recommended nomenclature for disease states of gout.MethodsA content analysis of gout-related articles from rheumatology and general internal medicine journals published over a 5-year period identified potential disease states and the labels commonly assigned to them. Based on these findings, experts in gout were invited to participate in a Delphi exercise and face-to-face consensus meeting to reach agreement on disease state labels and definitions.ResultsThe content analysis identified 13 unique disease states and a total of 63 unique labels. The Delphi exercise (n=76 respondents) and face-to-face meeting (n=35 attendees) established consensus agreement for eight disease state labels and definitions. The agreed labels were as follows: ‘asymptomatic hyperuricaemia’, ‘asymptomatic monosodium urate crystal deposition’, ‘asymptomatic hyperuricaemia with monosodium urate crystal deposition’, ‘gout’, ‘tophaceous gout’, ‘erosive gout’, ‘first gout flare’ and ‘recurrent gout flares’. There was consensus agreement that the label ‘gout’ should be restricted to current or prior clinically evident disease caused by monosodium urate crystal deposition (gout flare, chronic gouty arthritis or subcutaneous tophus).ConclusionConsensus agreement has been established for the labels and definitions of eight gout disease states, including ‘gout’ itself. The Gout, Hyperuricaemia and Crystal-Associated Disease Network recommends the use of these labels when describing disease states of gout in research and clinical practice.

ObjectiveInflammation and anti-inflammatory treatments might influence the risk of diabetes. The objective of this study was to assess factors associated with incident diabetes in rheumatoid arthritis (RA).MethodsThe study population consisted of RA patients from a multi-center cohort study, Corrona. To assess risk associated with disease modifying antirheumatic drug (DMARD) exposure, we assessed five mutually exclusive DMARD groups. Additionally, we assessed the risk associated with body mass index (BMI, 30 kg/m2) and glucocorticoid usage. Incident cases of diabetes were confirmed through adjudication, and Cox regression models were fit to estimate the risk of incident diabetes.ResultsWe identified 21,775 DMARD treatment regimens, the mean (SD) age at the index visit was 58 (13) years, disease duration 10 (10) years, and 30% used oral glucocorticoids at the time. Eighty-four incident cases of diabetes were confirmed within the treatment exposure periods. The hazard ratio (HR, 95% confidence interval) for diabetes was significantly reduced in patients receiving TNF inhibitors, HR 0.35 (0.13, 0.91), compared to patients treated with non-biologic DMARDs other than hydroxychloroquine and methotrexate. Hydroxychloroquine, methotrexate and use of other biologic DMARDs had a numerically reduced risk compared to the same group. Patients prescribed ≥7.5 mg of glucocorticoids had a HR of 2.33 (1.68, 3.22) of incident diabetes compared with patients not prescribed oral glucocorticoids. RA patients with a BMI >30 had a HR of 6.27 (2.97, 13.25) compared to patients with BMI ≤25.ConclusionDMARDs, glucocorticoids and obesity influenced the risk of incident diabetes in a large cohort of RA patients. Monitoring for the occurrence of diabetes should be part of routine RA management with a focus on specific subgroups.

Objective.To examine predictors of remission among patients with psoriatic arthritis (PsA) initiating a tumor necrosis factor (TNF) inhibitor.Methods.Patients with PsA enrolled in the Corrona Registry between 2005 and 2013 were followed from initiation of a TNF inhibitor (TNFi; etanercept, adalimumab, infliximab, certolizumab, or golimumab) to the visit closest to 12 months. Additional inclusion criteria included 3 tender or 3 swollen joints. Outcomes of interest were Clinical Disease Activity Index (CDAI) ≤ 2.8 (remission), low disease activity (LDA; CDAI ≤ 10), change in the modified Health Assessment Questionnaire (mHAQ) ≥ 0.35 and achievement of mHAQ < 0.30. Predictors were measured on or before TNFi initiation. Covariates significant in univariable logistic regression models and ≤ 5% missing values were included in a multivariable model and removed individually until all remaining variables were significant (p < 0.05).Results.Among 1832 TNFi initiations, 774 initiations (624 patients) met inclusion criteria. Median age at initiation was 52 years [interquartile range (IQR) 44–60], 56% were female, median PsA duration was 4 years (IQR 2–11), and median CDAI at baseline was 20 (IQR 14.5–28). Remission was achieved by 14% and LDA (or remission) by 37%. Achieving remission was positively associated with college education (OR 1.88, 95% CI 1.11–3.19) but negatively associated with female sex (0.62, 95% CI 0.40–0.97), obese body mass index (0.51, 95% CI 0.32–0.81), hypertension (0.55, 95% CI 0.32–0.95), previous biologic use (0.41, 95% CI 0.26–0.65), and baseline pain (0.80 per 10 mm visual analog scale, 95% CI 0.73–0.87). Predictors for LDA, mHAQ < 0.30, and mHAQ change were similar.Conclusion.Few patients with PsA in a US-based registry achieved remission by CDAI criteria. Female sex, obesity, comorbidities, and education influence achievement of remission on a TNFi.

OBJECTIVES: Adherence to a treat to target (TTT) strategy is a recommended paradigm for RA; however, research shows there are many barriers to implementation. We conducted a trial to improve TTT implementation, and herein examine barriers to treatment adjustment within TTT among patient visits not in agreement with the TTT paradigm. METHODS: Chart review assessed TTT implementation based on documentation of four items: designation of a treatment target, recording a disease activity measure, shared-decision making when applicable and adjusting treatment when disease activity was not at target. A treatment decision not in agreement with the TTT paradigm was defined as lack of treatment adjustment when disease activity was not at the pre-determined treatment target. Providers were encouraged to report the barriers to treatment change; these were categorized and analysed by study staff. Multiple barriers were possible for one visit. RESULTS: Eighty-three visits not in agreement with the TTT strategy were observed in 74 patients, during which 90 reported barriers to treatment adjustment were noted. Common barriers to adjusting treatment included patient preference in 37.1% of visits and elevated disease activity measure despite no objective evidence of active RA in 38.6% of visits. CONCLUSION: An elevated disease activity measure not reflective of RA disease activity and patient preference are the two leading barriers to treatment adjustment to TTT in RA. Understanding barriers to adherence should guide interventions aimed at using better markers of disease activity and improving alignment with patient preference, with the overarching goal of enhancing TTT adherence.

Background Specific patient demographics or disease characteristics may be associated with switching from one therapy to another for patients with RA. Identifying these predictive factors may help inform prospective treatment decisions. Objectives To examine factors predicting switching among patients with RA from a TNF inhibitor (TNFi) to a subsequent biologic (b)DMARD (TNFi or non-TNFi [abatacept, tocilizumab, rituximab]) or the targeted synthetic (ts)DMARD tofacitinib. Methods This analysis included patients aged ≥18 years, who were enrolled in a large sequential RA registry established in October 2001 and who initiated a TNFi on/after 1 January 2005 and had ≥24 months’ follow-up. Switch was defined as discontinuation of a TNFi and initiation of another bDMARD or tofacitinib within 6 months. Of TNFi initiations, 67% were randomly selected as a prediction dataset and used to develop the final model; 33% were considered in the validation dataset. Logistic regression modelling was used to predict switching status; baseline demographics (age, sex, race), patient attributes (smoking status, BMI, work status) and clinical characteristics (RF and anti-cyclic citrullinated protein status, erosive disease, history of co-morbidities, prior and current treatment, disease activity, patient-reported pain, fatigue, morning stiffness) were considered. Goodness-of-fit statistics were used to assess model fit and receiver operating characteristic curves (area under the curve [AUC]) to validate the model. Results Among 6909 eligible TNFi initiations, there were 1343 switchers (prediction dataset: 4623 TNFi initiations, including 898 switchers). Compared with non-switchers, switchers were younger, had a shorter duration of RA and higher baseline mean CDAI score. Fewer switchers were positive for erosive disease or on combination therapy with MTX, but more were on monotherapy or combination therapy with a non-MTX DMARD. After investigation of several models, the best-fit model (Table) to predict switching from a TNFi yielded an AUC=0.705 (sensitivity=81%; false positive rate=49%). Conclusions The model identified in this analysis revealed that factors including age, duration of RA, CDAI, history of co-morbid conditions, prior treatment and year of TNFi initiation predicted switching from a TNFi to another bDMARD or tsDMARD. Disclosure of Interest L. Harrold Shareholder of: Corrona, LLC, Grant/research support from: Pfizer, Consultant for: Roche, Bristol-Myers Squibb, Employee of: Corrona, LLC, University of Massachusetts Medical School, H. Litman Employee of: Corrona, LLC, S. Connolly Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, E. Alemao Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, S. Kelly Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, S. Rebello Employee of: Corrona, LLC, T. Blachley: None declared, J. Kremer Shareholder of: Corrona, LLC, Grant/research support from: AbbVie, Bristol-Myers Squibb, Genentech, Lilly, Novartis, Pfizer, Employee of: Corrona, LLC, Speakers bureau: Genentech (non-branded talks only)

Background Anti-citrullinated protein antibody (ACPA) is a highly specific biomarker for RA1 and ACPA-seropositive patients have a tendency toward severe erosive disease and more rapid disease progression.2–4 Little is known regarding the impact of poor prognostic factors, such as ACPA and erosive disease, on healthcare resource utilisation (HCRU). Objectives To characterise the rate of HCRU between anti-cyclic citrullinated peptide (anti-CCP; a surrogate of ACPA) positive (+) patients with or without erosions who initiated biologic (b)DMARD treatment. Methods This analysis included patients aged ≥18 years, who were enrolled in a large sequential RA registry (October 2001–August 2017) and who had known erosions, as measured by radiography, and anti-CCP +status at or prior to bDMARD initiation visit and a 12 month (±3 months) follow-up visit. Anti-CCP +was defined as ≥20 U/mL. Rates of HCRU, including all-cause hospitalizations, all joint surgeries (total and partial; all sites), radiographic procedures and use of assistive devices, were estimated over 12 months of follow-up from the bDMARD initiation visit in anti-CCP +patients with or without erosions. Rates of HCRU per 100 patient-years and risk ratios, adjusted by baseline age, were estimated with 95% CI using a Poisson regression model. Results A total of 2047 anti-CCP +patients were included in this analysis, 868 with and 1179 without erosions. At biologic initiation visit, mean (SD) age was 58.9 (12.5) and 55.9 (12.5) years and disease duration was 11.7 (10.1) and 6.4 (7.5) years, respectively, in anti-CCP +patients with and without erosions. Over 12 months of follow-up, the rates of HCRU were higher among anti-CCP +patients with versus those without erosions at baseline bDMARD initiation visit (table 1). Conclusions ACPA seropositivity with erosive disease predicts high utilisation of healthcare resources, suggesting that early therapeutic intervention may be warranted in anti-CCP +patients to achieve better disease control and reduce the complications from RA. References [1] Scott DL, et al. Lancet2010;376:1094–108. [2] van der Helm-van Mil AH, et al. Arthritis Res Ther2005;7:R949–58. [3] Hecht C, et al. Ann Rheum Dis2015;74:2151–6. [4] Harrold LH, et al. Arthritis Rheumatol2017:69(S10):499. Disclosure of Interest L. Harrold Shareholder of: Corrona, LLC, Grant/research support from: Pfizer, Consultant for: Roche, Bristol-Myers Squibb, L. Guo: None declared, S. Connolly Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, E. Alemao Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, S. Rebello Employee of: Corrona, LLC, Y. Shan Employee of: Corrona, LLC, J. Kremer Shareholder of: Corrona, LLC, Grant/research support from: AbbVie, Bristol-Myers Squibb, Genentech, Lilly, Novartis, Pfizer, Employee of: Corrona, LLC

Background Many patients with RA do not achieve guideline-recommended treat-to-target (T2T) goals in clinical practice. Little is known about the challenges that patients and rheumatologists face when attempting to achieve better control of RA disease activity. Objectives To identify and prioritise patient- and rheumatologist-perceived barriers to achieving RA disease activity control. Methods Participants were recruited from the Consortium of Rheumatology Researchers of North America (Corrona) registry and invited to participate in nominal groups (NGs), 4 with patients and 3 with rheumatologists. Each group generated a list of barriers to reaching RA disease control (patients) and T2T goals (rheumatologists). Two separate lists containing the generated items were created and were subjected to a card sort procedure to create common themes. A random sample of Corrona RA patients were invited by email to complete a compensated online survey and asked to rank their top 3 barriers. A weighted score was assigned for each barrier by considering the number of respondents who ranked it and the priority rank they assigned. The barriers/themes were sorted into domains. The patient survey also included knowledge items about T2T strategy and attitudes about RA treatment. Results Nominal groups with 37 RA patients identified 17 themes to achieving control of RA activity. Similarly, 8 themes emerged from the physician NGs, 7 of which were also found in the patient NGs (table 1). Cost of RA care was ranked highest by both patients and physicians, while medication risk aversion ranked second and third among the physician- and patient-generated barriers, respectively. We sent 1694 invitations to complete the survey and 450 patients with RA for whom clinical data was available responded within 3 weeks. There were no differences in age, sex, or disease duration between survey- respondents and non-respondents. A higher proportion of respondents were college-educated. A total of 344 (77%) respondents considered RA to be a high priority for their health, 225 (51%) reported being familiar with T2T as a treatment strategy, and 312 (85%) displayed core beliefs favouring medications. Among the challenges to controlling RA disease activity, the domain that received the highest score was unpredictability of RA and its treatment (figure 1). Symptoms and illness burden domain received the second highest score, followed by the health system factors domain (figure 1). Conclusions There are common patient- and physician-perceived barriers to achieving RA disease control. From the patient perspective important barriers are unpredictability of how RA may progress, medication risk aversion and cost of RA care. Addressing these barriers, when possible, may improve goal-directed RA care. Acknowledgements Pfizer IGLC, Corrona Disclosure of Interest None declared

OBJECTIVE Treat-to-target (TTT) is an accepted paradigm for care of patients with rheumatoid arthritis (RA). Because TTT can be associated with more medication switches, concerns arise regarding whether implementing TTT may increase adverse events and/or resource use. The aim of this study was to examine adverse events and resource use during the preintervention and intervention periods of the TTT intervention trial. METHODS We used data from 6 practices enrolled in an 18-month cluster-randomized controlled trial to compare adverse events and resource use before (months 1-9) and during (months 10-18) a TTT intervention. The outcomes of interest, adverse events and resource use, were based on medical record review of all rheumatology visits for RA patients before and during the intervention. RESULTS We examined records for 321 patients before the intervention and 315 during the intervention. An adverse event was recorded in 10.2% of visits before the intervention and 8.8% of visits during the intervention (P = 0.41). Biologic disease-modifying antirheumatic drugs were taken by 53.6% of patients before the intervention and 49.8% of patients during the intervention (P = 0.73). Rheumatology visits were more frequent before the intervention (mean ± SD 4.0 ± 1.4) than during the intervention (mean ± SD 3.6 ± 1.2; P = 0.02). More visits were accompanied by monitoring laboratory tests before the intervention (90.0%) compared with during the intervention (52.7%; P < 0.001). A greater percentage of visits before the intervention included diagnostic imaging (15.4%) versus during the intervention (8.9%; P < 0.001). CONCLUSION We observed similar rates of adverse events before and during the implementation of TTT for RA. Rheumatology visits, use of laboratory monitoring, and diagnostic imaging did not increase during the TTT intervention.

Objective.To analyze prophylaxis using the CORRONA (COnsortium of Rheumatology Researchers Of North America) Gout Registry according to the American College of Rheumatology (ACR) guidelines, and to evaluate whether differences in disease characteristics influenced prophylaxis.Methods.All patients with gout in the CORRONA Gout Registry between November 1, 2012, and November 26, 2013, were included. They were divided into 2 groups: “receiving prophylaxis” versus “not receiving prophylaxis” at the time of enrollment. Patients having a flare at time of visit were excluded. Descriptive statistics and multivariable logistic regression models were performed to evaluate the factors associated with prophylaxis.Results.There were 1049 patients with gout available for analysis. There were 441 patients (42%) receiving prophylaxis and 608 (58%) not receiving prophylaxis. The most common drugs used for prophylaxis were colchicine (78%) and nonsteroidal antiinflammatory drugs (32%). Prophylaxis drug combination was used by 45 patients (10.2%). Patients in the “receiving prophylaxis” group were more likely to have a gout duration of ≤ 1 year (n = 68, p < 0.001), ≥ 1 flare in the year previous to enrollment (p < 0.001), ≥ 1 healthcare uses in the last year [Emergency Department (p = 0.029); outpatient visit to primary care, rheumatologist, or urgent care clinic (p < 0.001)], have tophi (p < 0.001), report pain > 3 (p = 0.001), and have disease activity > 10 (p < 0.001) compared with patients in the “not receiving prophylaxis” group.Conclusion.Forty-two percent of patients with gout in the CORRONA Gout Registry were receiving prophylaxis. Prophylaxis was significantly more common in patients with a higher disease burden and activity, which is in agreement with the ACR guidelines. Our study highlights disease characteristics influencing prophylaxis and furthers our knowledge on current use of flare prophylaxis.

Background Use of several immunomodulatory agents has been associated with reduced cardiovascular (CV) events in epidemiologic studies of rheumatoid arthritis (RA). However, it is unknown whether time-averaged disease activity in RA correlates with CV events.

Objective.To characterize the real-world effectiveness of rituximab (RTX) in patients with rheumatoid arthritis.Methods.Clinical effectiveness at 12 months was assessed in patients who were prescribed RTX based on the Clinical Disease Activity Index (CDAI). Change in CDAI was calculated (CDAI at 12 mos minus at initiation). Achievement of remission or low disease activity (LDA; CDAI ≤ 10) among those with moderate/high disease activity at the time of RTX initiation was compared based on prior anti-tumor necrosis factor agent (anti-TNF) use (1 vs ≥ 2) using logistic regression models.Results.Patients (n = 265) were followed for 12 months with a mean change in CDAI of −8.1 (95% CI −9.8 – −6.4). Of the 218 patients with moderate/high disease activity at baseline, patients with 1 prior anti-TNF (baseline CDAI 25.0) demonstrated a mean change in CDAI of −10.1 (95% CI −13.2 – −7.0); patients with ≥ 2 prior anti-TNF (baseline CDAI 30.0) demonstrated a mean change of −10.5 (95% CI −12.9 – −8.0). The unadjusted OR for achieving LDA/remission in patients with moderate/high disease activity at baseline exposed to ≥ 2 versus 1 prior anti-TNF was 0.40 (95% CI 0.22–0.73), which was robust to 4 different adjusted models (OR range 0.38–0.44).Conclusion.A good clinical response was observed in all patients; however, patients previously treated with 1 anti-TNF, who had lower baseline CDAI and a greater opportunity for clinical improvement compared with patients previously treated with ≥ 2 anti-TNF, were more likely to achieve LDA/remission.

Objective Depression is common in the rheumatoid arthritis (RA) population, yet little is known of its effect on the course of disease activity. The aim of our study was to determine if prevalent and incident depressive symptoms influenced longitudinal changes in RA disease activity. Methods RA patients with and without depressive symptoms were identified using single-item questions from an existing registry sample. Mixed-effects models were used to examine changes in disease activity over 2 years in those with and without prevalent and incident depressive symptoms. Outcome variables included composite disease activity, joint counts, global assessments, pain, function, and acute-phase reactants. Model-based outcome estimations at the index dates and corresponding 1- and 2-year changes were calculated. Results Rates of disease activity change were significantly different in patients with a lifetime prevalence of symptomology, but not incident depressive symptoms, when compared to controls. Prior symptoms were associated with slower rates of disease activity decline, evidenced by the estimated 1-year Clinical Disease Activity Index changes: −3.0 (−3.3, −2.6) and −4.0 (−4.3, −3.6) in patients with and without lifetime prevalence, respectively. Analogous results were obtained for most of the other disease activity outcomes; although, there was no temporal effect of prevalent symptoms of depression on swollen joints and acute-phase reactants. Conclusion Depressive symptoms temporally influence the evolution of RA disease activity, and the magnitude is dependent on the time of symptomatic onset. However, the effect is limited to patient-reported pain, global assessment, and function, as well as physician-reported global assessment and tender joints.

Background Registry studies provide a valuable source of comparative safety data for tumor necrosis factor inhibitors (TNFi) used in rheumatoid arthritis (RA), but they are subject to channeling bias. Comparing safety outcomes without accounting for channeling bias can lead to inaccurate comparisons between TNFi prescribed at different stages of the disease. In the present study, we examined the incidence of serious infection and other adverse events during certolizumab pegol (CZP) use vs other TNFi in a U.S. RA cohort before and after using a methodological approach to minimize channeling bias. Methods Patients with RA enrolled in the Corrona registry, aged ≥ 18 years, initiating CZP or other TNFi (etanercept, adalimumab, golimumab, or infliximab) after May 1, 2009 (n = 6215 initiations), were followed for ≤ 12 months. A propensity score (PS) model was used to control for baseline characteristics associated with the probability of receiving CZP vs other TNFi. Incidence rate ratios (IRRs) of serious infectious events (SIEs), malignancies, and cardiovascular events (CVEs) in the CZP group vs other TNFi group were calculated with 95% CIs, before and after PS matching. Results Patients were more likely to initiate CZP later in the course of therapy than those initiating other TNFi. CZP initiators (n = 975) were older and had longer disease duration, more active disease, and greater disability than other TNFi initiators (n = 5240). After PS matching, there were no clinically important differences between CZP (n = 952) and other TNFi (n = 952). Before PS matching, CZP was associated with a greater incidence of SIEs (IRR 1.53 [95% CI 1.13, 2.05]). The risk of SIEs was not different between groups after PS matching (IRR 1.26 [95% CI 0.84, 1.90]). The 95% CI of the IRRs for malignancies or CVEs included unity, regardless of PS matching, suggesting no difference in risk between CZP and other TNFi. Conclusions After using PS matching to minimize channeling bias and compare patients with a similar likelihood of receiving CZP or other TNFi, the 1-year risk of SIEs, malignancies, and CVEs was not distinguishable between the two groups. Electronic supplementary material The online version of this article (doi:10.1186/s13075-017-1496-5) contains supplementary material, which is available to authorized users.