Faculty Bibliography

OBJECTIVE:To examine the real-world effectiveness of secukinumab with regard to clinical and patient-reported outcomes (PROs) from enrollment to a 6-month follow-up visit in patients with psoriasis in the Corrona Psoriasis Registry. METHODS:Eligible patients aged ≥ 18 years who initiated secukinumab at enrollment in the Corrona Psoriasis Registry and had a 6-month follow-up visit (window: 5-9 months) as of December 31 2017, were included in the analysis. Measures of disease severity and PROs were assessed in patients who maintained secukinumab treatment at the 6-month follow-up visit. RESULTS:Of the 144 patients who initiated secukinumab at enrollment and had a 6-month follow-up visit, 118 (81.9%) maintained secukinumab treatment at 6 months and demonstrated significant improvements in affected body surface area (BSA) and 5-point Investigator's Global Assessment (IGA) score (all p < .01). The majority of patients were biologic experienced (89.8%). In addition, patients reported significant improvements in quality of life, as well as in pain, itch, fatigue, work productivity, and daily activities (all p < .01). CONCLUSIONS:Secukinumab significantly improved disease severity and PROs after 6 months of follow-up in this real-world study, which is consistent with other current real-world studies.

OBJECTIVES/OBJECTIVE:This analysis examined the association between psoriasis severity, assessed by body surface area (BSA) and the Investigator's Global Assessment (IGA; previously used only in clinical trials), and patient-reported outcomes (PROs) in a real-world setting. DESIGN/METHODS:Cross-sectional analysis within the Corrona Psoriasis Registry, an independent, prospective registry. SETTING/METHODS:70 dermatology practices in the USA. PARTICIPANTS/METHODS:1529 adult patients with psoriasis being treated with biological or non-biological systemic psoriasis treatment by 31 May 2016. PRIMARY AND SECONDARY OUTCOME MEASURES/UNASSIGNED:tests. The association between psoriasis severity and PROs was examined using multivariable regression models. RESULTS:The mean age was 50.6 years and 47% of patients were female. Consistently with more severe psoriasis, symptoms worsened, DLQI scores increased (p<0.05 for each level of BSA and IGA), EQ-VAS decreased (p<0.05 for each level of BSA and IGA) and WPAI scores increased. By BSA score, moderate to very severe psoriasis was associated with poorer outcomes for the 'impairment while working' and 'daily activities impaired' WPAI domains (all p<0.05 vs mild psoriasis). Very severe psoriasis was associated with increased 'work hours missed' and 'work hours affected' (both p<0.05 vs mild psoriasis) Findings were similar by IGA. Results were confirmed by multivariable regression analyses. CONCLUSIONS:In a real-world setting, more severe psoriasis, assessed by BSA and IGA, was consistently associated with worse PROs.

Background: The Psoriasis Epidemiology Screening Tool (PEST) is a 5-item questionnaire developed to help identify psoriatic arthritis (PsA) at an early stage, with a score >=3 indicative of PsA.¹ The objective of this study was to assess the risk of undiagnosed PsA among patients with psoriasis and characterize patients based on PEST scores in a US cohort.
Method(s): This study included all patients enrolled in the Corrona Psoriasis Registry with data on all 5 PEST questions. Demographics, disease characteristics, patient-reported outcomes (PROs), and medication use were analyzed at the time of enrollment and stratified by PEST score (0, 1, 2, or >=3). Pairwise comparisons were made between PEST score = 0 (reference) and other PEST score groups using t tests for continuous variables and chi² tests for categorical variables.
Result(s): As of June 2016, 99.1% (1516/1529) of patients in the Corrona Psoriasis Registry had data on all 5 PEST questions; 612 (40.4%) patients had dermatologist-reported PsA at enrollment. Among the remaining 904 patients, 421 (46.6%) patients had a PEST score = 0, 225 (24.9%) had a PEST score = 1, 146 (16.2%) had a PEST score = 2, and 112 (12.4%) had a PEST score >=3. Of patients with a PEST score >=3, patients most commonly answered "yes" to "Have you ever had a swollen joint (or joints)?" (89%) and "Has a doctor ever told you that you have arthritis?" (86%). Compared with patients with a PEST score = 0, patients with a PEST score >=1 all had a higher BMI, longer duration of psoriasis, increased family history of PsA, increased prevalence of nail psoriasis, and worse EQ-VAS at enrollment (all P < .05; Table 1). In addition, patients with PEST scores >=2 were older, more likely to be female, less likely to be employed, and had an increased family history of psoriasis, worse pain and fatigue, worse dermatology-related quality of life, and higher percentage impairment of daily activities due to psoriasis at enrolment versus patients with a PEST score = 0 (all P < .05). There were no significant differences across PEST scores in affected body surface area or PASI scores.
Conclusion(s): In this cohort of psoriasis patients with no diagnosis of PsA, patients with PEST scores >=2 were significantly different from those with PEST scores = 0 for many characteristics at enrollment, including BMI and PROs. These findings highlight the value of screening for PsA among patients with psoriasis in order to potentially improve patient outcomes

OBJECTIVE:Inflammation 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). METHODS:The 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, <25, 25-30, >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. RESULTS:We 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. CONCLUSION/CONCLUSIONS:DMARDs, 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/UNASSIGNED:To examine patterns of tumour necrosis factor inhibitor (TNFi) use in TNFi-naive and TNFi-experienced patients with psoriatic arthritis (PsA) in the USA. Methods/UNASSIGNED:All patients aged ≥18 years with PsA enrolled in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry who initiated a TNFi (index therapy) between March 2013 and January 2017 and had ≥1 follow-up visit were included. Times to and rates of discontinuation/switch of the index TNFi were compared between TNFi-naive and TNFi-experienced cohorts. Patient demographics and disease characteristics at the time of TNFi initiation (baseline) were compared between cohorts and between patients who continued versus discontinued their index TNFi by the first follow-up visit within each cohort. Results/UNASSIGNED:This study included 171 TNFi-naive and 147 TNFi-experienced patients (total follow-up, 579.2 person-years). Overall, 75 of 171 TNFi-naive (43.9%) and 80 of 147 TNFi-experienced (54.4%) patients discontinued their index TNFi; 33 of 171 (19.3%) and 48 of 147 (32.7%), respectively, switched to a new biologic. TNFi-experienced patients had a shorter time to discontinuation (median, 20 vs 27 months) and were more likely to discontinue (p=0.03) or switch (p<0.01) compared with TNFi-naive patients. Among those who discontinued, 49 of 75 TNFi-naive (65.3%) and 59 of 80 TNFi-experienced (73.8%) patients discontinued by the first follow-up visit; such patients showed a trend towards higher baseline disease activity compared with those who continued. Conclusions/UNASSIGNED:The results of this real-world study can help inform treatment decisions when selecting later lines of therapy for patients with PsA.

Objective/UNASSIGNED:To compare the characteristics of patients with psoriatic arthritis among patient groups stratified by degree of skin and joint involvement, and to evaluate the relationship between skin severity and joint activity. Methods/UNASSIGNED:test, Cramer's V) and continuous variables (linear regression). Results/UNASSIGNED:1542 adult patients in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry enrolled between 21 May 2013 and 20 September 2016 were analysed. Most patients in the BSA >3%/CDAI moderate/high subgroup had worse clinical and patient-reported outcomes. A significant (p<0.001) modest association (Cramer's V=0.1639) between skin severity and joint activity was observed among all patients at enrolment. Patients with higher skin severity were two times more likely to have higher joint involvement (OR 2.27, 95% CI 1.71 to 3.01). A significant linear relationship between CDAI and BSA was observed. Effect modification showed this linear relationship was modified by age, gender, insurance, work status, current therapy, Health Assessment Questionnaire, Nail visual analogue scale, minimal disease activity, dactylitis count, patient-reported pain and fatigue. Conclusion/UNASSIGNED:Skin severity is modestly correlated with joint activity, and patients with higher skin severity are two times more likely to have increased joint involvement. Clinicians need to address both skin severity and joint activity in treatment decisions.

INTRODUCTION/BACKGROUND:Tumor necrosis factor inhibitors (TNFis) have shown efficacy for the treatment of ankylosing spondylitis (AS). However, many patients may discontinue or switch TNFis due to lack of effect or adverse events. As biologics with alternative mechanisms of action become available for the treatment of AS, it is important to better understand the characteristics of patients who discontinue or have an inadequate response to TNFis to help inform treatment choices regarding initiating or switching to a biologic therapy. This study compared demographic and clinical characteristics of patients with AS who discontinued vs. continued a TNFi by their second follow-up visit in the US-based Corrona Psoriatic Arthritis and Spondyloarthritis (PsA/SpA) Registry. METHODS:All patients aged ≥ 18 years with AS enrolled in the Corrona PsA/SpA Registry between April 2013 and January 2015 who were receiving or had initiated a TNFi (index therapy) at the time of registry enrollment (baseline) and had ≥ 2 follow-up visits were included. Patient demographics, clinical characteristics, and patient-reported outcome scores at baseline were compared between cohorts of patients who discontinued or continued their TNFi by the second follow-up visit. RESULTS:Of the 155 included patients, 37 (23.9%) discontinued their index TNFi therapy by the second follow-up visit (mean follow-up, 17.8 months). Patients who discontinued their TNFi were older (mean age, 52.1 vs. 46.6 years; P = 0.04), were more likely to be obese (59.5% vs. 34.2%; P < 0.01), and had worse mean Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores (4.8 vs. 3.5 and 4.2 vs. 2.8, respectively; P = 0.01 for both) at baseline than those who continued their TNFi. CONCLUSIONS:The results of this real-world study provide insight into the demographic and clinical characteristics of patients with AS who discontinue vs. continue TNFi therapy in US clinical practice. FUNDING/BACKGROUND:Corrona, LLC. Plain language summary available for this article.

OBJECTIVE:To describe the characteristics of patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) in the United States. METHODS:Demographics, clinical characteristics, patient-reported outcomes, and treatment characteristics of patients with AS and nr-axSpA were assessed at the time of enrollment in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry. AS was defined as patients who fulfilled the 1984 modified New York criteria for AS; nr-axSpA was defined as all other patients with axSpA who did not fulfill the radiologic criterion. RESULTS:Of the 407 patients with a diagnosis of axSpA included in this study, 310 patients (76.2%) had AS, and 97 patients (23.8%) had nr-axSpA. Although patients with nr-axSpA were younger and showed a trend for shorter symptom duration, the nr-axSpA and AS groups shared a similar disease burden, as reflected by comparisons of disease activity and function, quality of life, pain, fatigue, absenteeism, and work productivity loss (all P > 0.05). The proportions of patients receiving prior (74.2% vs 64.8%) and current biologic disease-modifying antirheumatic drugs (63.9% vs 61.3%) were also similar between patients with nr-axSpA and AS, respectively (P > 0.05). CONCLUSION/CONCLUSIONS:This was the first nationwide study to characterize patients with AS and nr-axSpA in the United States. Consistent with studies published outside the United States, this study showed that patients with nr-axSpA and AS shared a comparable degree of disease burden, and had similar treatment patterns in clinical practice.