Meaningful Improvement and Worsening in Patients Who Do Not Achieve Low Disease Activity and Switch Therapy to a New Biologic or Targeted Disease-Modifying Antirheumatic Drug: Results From the CorEvitas RA Registry.

OBJECTIVE: The aim of this study was to assess the change in disease activity associated with switching from 1 biologic/targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) to another in patients with rheumatoid arthritis who did not achieve low disease activity (LDA) after 6 to 12 months of their initial treatment. METHODS: This observational study included patients from the CorEvitas Rheumatoid Arthritis Registry, who initiated a b/tsDMARD at the index visit (prebaseline), had any clinical disease activity index (CDAI) improvement but did not achieve LDA/remission at the subsequent visit (baseline), and switched therapy at baseline or between baseline and follow-up visits. Regardless of the preswitch CDAI value, 2 thresholds of CDAI change were used to define meaningful improvement and worsening for all patients: ≥6 units and ≥12 units; no meaningful change was defined as any change between -6 to +6 units and -12 to +12 units, based on respective thresholds. RESULTS: Of 1226 patients fulfilling the inclusion criteria, 93 (7.6%) switched therapy at baseline or between baseline and follow-up, after an inadequate response at the baseline visit. At follow-up, meaningful worsening occurred in 30.1% and 12.9% of switchers, whereas the remaining switchers achieved meaningful improvement (34.4% and 20.4%) or had no meaningful change (35.5% and 66.7%), based on the thresholds of ≥6 and ≥12 units, respectively. CONCLUSIONS: Rheumatoid arthritis patients, who had not achieved LDA and switched b/tsDMARD, were more likely to have meaningful improvement or no change, rather than meaningful worsening. These data may help some patients overcome their hesitancy to switch therapy, potentially improving clinical outcomes.

Socioeconomic impact of treatment with biological disease-modifying antirheumatic drugs in Japanese patients with rheumatoid arthritis.

OBJECTIVES: We evaluate the socioeconomic impact of treatment with biological and targeted synthetic disease-modifying antirheumatic drugs in Japanese patients with rheumatoid arthritis. METHODS: We analysed data retrospectively from the prospective observational CorEvitas RA Japan Registry (March 2016-February 2020). Patients were categorised into paid workers (PWs) and home workers (HWs) and further based on drug classes. We assessed medication persistence, treatment outcomes, health care resource utilisation, and socioeconomic impact over 12 months, including direct (drugs and health care resource utilisation) and indirect (loss of productivity) costs. RESULTS: Overall, 187 PWs and 114 HWs were identified. Over 12 months, medication persistence was high, treatment outcomes improved, and outpatient visits reduced in both groups. Following treatment initiation, direct costs increased, whereas indirect (loss of productivity) costs decreased in both groups. The unadjusted socioeconomic impact [Japanese yen (JPY)] increased across all drug classes in PWs (range: 29,700-151,700) and HWs (range: -28,700 to 83,000). Adjusted change in monthly socioeconomic impact was JPY 29,700-138,900 for PWs and JPY -28,000 to 92,800 for HWs. CONCLUSIONS: In this study of Japanese patients with rheumatoid arthritis, the socioeconomic burden increased across patient groups and drug classes. The decrease in indirect (loss of productivity) costs partially offset the increase in direct costs.

Comparative effectiveness of first-line tumour necrosis factor inhibitor versus non-tumour necrosis factor inhibitor biologics and targeted synthetic agents in patients with rheumatoid arthritis: results from a large US registry study.

OBJECTIVES: This study evaluated the comparative effectiveness of a tumour necrosis factor inhibitor (TNFi) versus a non-TNFi (biological disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs)) as the first-line treatment following conventional synthetic DMARDs, as well as potential modifiers of response, observed in US clinical practice. METHODS: Data were from a large US healthcare registry (Consortium of Rheumatology Researchers of North America Rheumatoid Arthritis Registry). The analysis included patients (aged ≥18 years) with a documented diagnosis of rheumatoid arthritis (RA), a valid baseline Clinical Disease Activity Index (CDAI) score of >2.8 and no prior bDMARD or tsDMARD use. Outcomes were captured at 1-year postinitiation of a TNFi (adalimumab, etanercept, certolizumab pegol, golimumab or infliximab) or a non-TNFi (abatacept, tocilizumab, rituximab, anakinra or tofacitinib) and included CDAI, 28-Joint Modified Disease Activity Score, patient-reported outcomes (including the Health Assessment Questionnaire Disability Index, EuroQol-5 Dimension score, sleep, anxiety, morning stiffness and fatigue) and rates of anaemia. Groups were propensity score-matched at baseline to account for potential confounding. RESULTS: There were no statistically significant differences observed between the TNFi and non-TNFi treatment groups for outcomes assessed, except the incidence rate ratio for anaemia, which slightly favoured the TNFi group (19.04 per 100 person-years) versus the non-TNFi group (24.01 per 100 person-years, p=0.03). No potential effect modifiers were found to be statistically significant. CONCLUSIONS: The findings of no significant differences in outcomes between first-line TNF versus first-line non-TNF groups support RA guidelines, which recommend individualised care based on clinical judgement and consideration of patient preferences.

Association between cycline antibiotic and development of pseudotumor cerebri syndrome.

BACKGROUND: Cycline antibiotics (CAs) are commonly used to treat acne, blepharitis, and dry eye syndrome. Prescribers or patients may hesitate to use Cas because they may increase the risk of pseudotumor cerebri syndrome (PTCS). OBJECTIVE: We sought to assess whether CA use is associated with an increased risk of PTCS or papilledema and whether the risk depends upon dosage or duration of CA intake. METHODS: We studied patients 12 to 65 years of age who were diagnosed with acne, blepharitis, or dry eye syndrome, who were enrolled in a nationwide managed care network between January 1, 2001 and December 31, 2015, and who had no preexisting diagnosis of papilledema or PTCS. Multivariable Cox regression modeling was used to assess the risk of developing papilledema or PTCS from exposure to CAs. RESULTS: Among the 728,811 eligible enrollees (mean age, 34.7 years; 72% female), 42.0% filled ≥1 CA prescription. Of the 305,823 CA users, 170 (0.06%) were diagnosed with papilledema or PTCS. By comparison, of the 57.0% with no record of CA use, 121 (0.03%) were diagnosed with papilledema or PTCS (P < .0001). In the unadjusted model, every additional year of CA use was associated with a 70% (doxycycline: hazard ratio, 1.70 [95% confidence interval 0.98-2.97]; P = .06) or 91% (minocycline: hazard ratio, 1.91 [95% confidence interval 1.11-3.29]; P = .02) increased hazard of papilledema/PTCS relative to nonusers of CAs. After adjustment for confounders, the increased hazard of PTCS/papilledema with CA use was no longer statistically significant (P = .06, doxycycline; P = .08, minocycline). LIMITATIONS: This study relies on claims data, which lack clinical data. CONCLUSION: This study offers some evidence that CAs may increase the risk of PTCS/papilledema. However, after accounting for confounding factors in our multivariable models, we found no statistically significant association between CA use and the development of PTCS. Moreover, there was no dose-response effect whereby greater CA use was associated with a higher PTCS risk.

Antibiotic Prescription Fills for Acute Conjunctivitis among Enrollees in a Large United States Managed Care Network.

PURPOSE: Antibiotics are seldom necessary to treat acute conjunctivitis. We assessed how frequently patients with newly diagnosed acute conjunctivitis fill prescriptions for topical antibiotics and factors associated with antibiotic prescription fills. DESIGN: Retrospective, observational cohort study. PARTICIPANTS: A total of 340 372 enrollees in a large nationwide United States managed care network with newly diagnosed acute conjunctivitis, from 2001 through 2014. METHODS: We identified all enrollees newly diagnosed with acute conjunctivitis, calculating the proportion filling 1 or more topical antibiotic prescription within 14 days of initial diagnosis. Multivariate logistic regression assessed sociodemographic, medical, and other factors associated with antibiotic prescription fills for acute conjunctivitis. Geographic variation in prescription fills also was studied. MAIN OUTCOME MEASURES: Odds ratios (ORs) with 95% confidence intervals (CIs) for filling an antibiotic prescription for acute conjunctivitis. RESULTS: Among 340 372 enrollees with acute conjunctivitis, 198 462 (58%) filled ≥1 topical antibiotic prescriptions; 38 774 filled prescriptions for antibiotic-corticosteroid combination products. Compared with whites, blacks (OR, 0.89; 95% CI, 0.86-0.92) and Latinos (OR, 0.83; 95% CI, 0.81-0.86) had lower odds of filling antibiotic prescriptions. More affluent and educated enrollees had higher odds of filling antibiotic prescriptions compared with those with lesser affluence and education (P < 0.01 for all). Compared with persons initially diagnosed with acute conjunctivitis by ophthalmologists, enrollees had considerably higher odds of antibiotic prescription fills if first diagnosed by an optometrist (OR, 1.26; 95% CI, 1.21-1.31), urgent care physician (OR, 3.29; 95% CI, 3.17-3.41), internist (OR, 2.79; 95% CI, 2.69-2.90), pediatrician (OR, 2.27; 95% CI, 2.13-2.43), or family practitioner (OR, 2.46; 95% CI, 2.37-2.55). Antibiotic prescription fills did not differ for persons with versus without risk factors for development of serious infections, such as contact lens wearers (P = 0.21) or patients with human immunodeficiency virus infection or AIDS (P = 0.60). CONCLUSIONS: Nearly 60% of enrollees in this managed care network filled antibiotic prescriptions for acute conjunctivitis, and 1 of every 5 antibiotic users filled prescriptions for antibiotic-corticosteroids, which are contraindicated for acute conjunctivitis. These potentially harmful practices may prolong infection duration, may promote antibiotic resistance, and increase costs. Filling antibiotic prescriptions seems to be driven more by sociodemographic factors and type of provider diagnosing the enrollee than by medical indication.

Geographic Variation in the Use of Diagnostic Testing of Patients with Newly Diagnosed Open-Angle Glaucoma.

PURPOSE: To determine the extent of geographic variation in the proportion of patients with newly diagnosed open-angle glaucoma (OAG) undergoing visual field (VF) testing, fundus photography (FP), and other ocular imaging (OOI) among patients residing in different US communities. DESIGN: Retrospective, longitudinal cohort study. PARTICIPANTS: All enrollees with newly diagnosed OAG enrolled in a managed care network between 2001 and 2014. METHODS: We identified all persons in the plan with incident OAG residing in 201 communities across the United States. All communities contributed ≥20 enrollees. The proportion of enrollees undergoing ≥1 VF test, FP, OOI, and no testing of any type in the 2 years after first OAG diagnosis was determined for each community, and comparisons were made to assess the extent of variation in use of diagnostic testing among patients residing in the different communities. MAIN OUTCOME MEASURES: Receipt of VF testing, FP, OOI, or none of these tests in the 2 years after initial OAG diagnosis. RESULTS: Of the 56675 enrollees with newly diagnosed OAG, the mean proportion of patients undergoing VF testing within 2 years of initial diagnosis was 74%±7%, ranging from as low as 51% in Rochester, Minnesota, to as high as 95% in Lancaster, Pennsylvania. The mean proportion undergoing OOI was 63%±10% and varied from 34% in Palm Springs/Rancho Mira, California, to 85% in Charleston, South Carolina. The mean proportion receiving FP was 26%±10% and ranged from as low as 3% in Fresno, California, to as high as 57% in Harlingen, Texas. The proportion undergoing no glaucoma testing ranged from 0% in Binghamton, New York, to as high as 35% in 2 other communities. CONCLUSIONS: In many US communities, a high proportion of patients are undergoing testing according to established practice guidelines. However, in several communities, less than 60% of patients with newly diagnosed OAG are undergoing VF testing in the 2 years after initial OAG diagnosis, and in a few communities >1 in 4 patients have no record of glaucoma diagnostic testing of any type. Additional research is needed to understand factors driving this variation in practice patterns and its impact on patient outcomes.

The Association Between Sociodemographic Factors, Common Systemic Diseases, and Keratoconus: An Analysis of a Nationwide Heath Care Claims Database.

PURPOSE: The purpose of this study was to determine whether an association exists between common systemic diseases, sociodemographic factors, and keratoconus (KCN) among a large, diverse group of insured individuals in the United States. DESIGN: Retrospective longitudinal cohort study. PARTICIPANTS: Sixteen thousand fifty-three patients with KCN were matched 1:1 with persons without KCN. METHODS: Persons with KCN were identified using billing codes and matched by age, gender, and overall health with a control group with no record of KCN. Multivariable logistic regression assessed whether sociodemographic factors and certain systemic diseases affected the odds of KCN. MAIN OUTCOME MEASURES: Odds ratios (ORs) with 95% confidence intervals (CIs) of receiving a KCN diagnosis. RESULTS: After adjustment for confounders, black persons had 57% higher odds (adjusted OR, 1.57; 95% CI, 1.38-1.79; P < 0.001) and Latino persons had 43% higher odds (adjusted OR, 1.43; 95% CI, 1.26-1.62; P < 0.001) of being diagnosed with KCN compared with whites. Asians had 39% reduced odds (adjusted OR, 0.61; 95% CI, 0.50-0.75; P < 0.001) of being diagnosed with KCN compared with whites. Patients with uncomplicated diabetes mellitus (DM) had 20% lower odds of KCN (adjusted OR, 0.80; 95% CI, 0.71-0.90; P = 0.002), and patients with DM complicated by end-organ damage had 52% lower odds of having KCN (adjusted OR, 0.48; 95% CI, 0.40-0.58; P < 0.001) compared with those without DM. Persons with collagen vascular disease had 35% lower odds of KCN (adjusted OR, 0.65; 95% CI, 0.47-0.91; P = 0.01). Other conditions found to have increased odds of KCN included sleep apnea (adjusted OR, 1.13; 95% CI, 1.00-1.27; P = 0.05), asthma (adjusted OR, 1.31; 95% CI, 1.17-1.47; P < 0.001), and Down syndrome (adjusted OR, 6.22; 95% CI, 2.08-18.66; P < 0.001). There was no association between KCN and allergic rhinitis, mitral valve disorder, aortic aneurysm, or depression (P > 0.1 for all comparisons). CONCLUSIONS: Clinicians caring for persons with KCN should inquire about breathing or sleeping and, when appropriate, refer patients for evaluation for sleep apnea or asthma. Patients with DM have lower risk of KCN, potentially because of corneal glycosylation.

Rates of Vitrectomy among Enrollees in a United States Managed Care Network, 2001-2012.

PURPOSE: To determine whether vitrectomy surgery rates have changed over the past decade and factors affecting the odds of undergoing this procedure. DESIGN: Retrospective, longitudinal cohort study. PARTICIPANTS: All enrollees 21 years of age or older between 2001 and 2012 in a United States managed care network. METHODS: Claims data from a managed care network were analyzed to identify all enrollees who underwent 1 vitrectomy or more each year from 2001 through 2012. Rates of vitrectomy per 1000 enrollees were computed each year from 2001 through 2012 for the entire group and separately for patients with and without diabetes mellitus. Multivariate logistic regression assessed factors affecting the odds of undergoing vitrectomy surgery. MAIN OUTCOME MEASURES: Annual rates of vitrectomy surgery from 2001 through 2012 and odds ratios (ORs) of undergoing a vitrectomy with 95% confidence intervals (CIs). RESULTS: Among the 11 161 907 eligible enrollees, 40 892 (0.4%) underwent vitrectomy over the 12-year period. The average age of those undergoing vitrectomy was 57±13 years. Overall vitrectomy rates increased 31% from 2001 to 2012 (from 1.47 to 1.92 per 1000 patients). During this same period, the vitrectomy rate among persons with diabetes mellitus decreased by 43% (from 5.84 to 3.31 per 1000 patients with diabetes). Women had 24% decreased odds of undergoing vitrectomy (adjusted odds ratio [OR], 0.76; 95% confidence interval [CI], 0.72-0.79). The odds of undergoing a vitrectomy were 17% greater for black persons (adjusted OR, 1.17; 95% CI, 1.07-1.27) and 7% higher for persons with diabetes (adjusted OR, 1.07; 95% CI, 1.01-1.14). CONCLUSIONS: Overall, we observed an increase in the vitrectomy rates per 1000 enrollees in this large managed care network over the course of the past decade. However, among persons with diabetes mellitus, vitrectomy rates declined substantially over this period. These changes may be explained, in part, by advances in surgical instrumentation and imaging methods to detect retinal diseases changing indications for surgery, improvements in diabetes care, and alternative treatment options for managing retinal conditions. These results may be useful for future planning of manpower needs and highlight the need for aggressive prevention of complications in black persons with diabetes.

Demographic, Systemic, and Ocular Factors Associated with Nonarteritic Anterior Ischemic Optic Neuropathy.

OBJECTIVE: Nonarteritic anterior ischemic optic neuropathy (NAION) is a devastating ocular condition causing permanent vision loss. Little is known about risk factors for developing this disease. We assessed demographic, systemic, and ocular factors associated with NAION. DESIGN: Retrospective longitudinal cohort study. PARTICIPANTS: Beneficiaries between 40 and 75 years old without NAION at baseline enrolled in a large U.S. managed care network. METHODS: Enrollees were monitored continuously for ≥2 years between 2001 and 2014 to identify those newly diagnosed with NAION (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] code 377.41). All persons were under ophthalmic surveillance and all cases had ≥1 confirmatory ICD-9-CM code for NAION during follow-up. MAIN OUTCOME MEASURES: Multivariable Cox regression modeling was used to generate hazard ratios (HRs) with 95% confidence intervals (CIs) to describe the statistical relationship between selected demographic characteristics, systemic and ocular conditions, and the hazard of developing NAION. RESULTS: Of 1 381 477 eligible enrollees, 977 (0.1%) developed NAION during a mean ± standard deviation (SD) follow-up of 7.8±3.1 years. The mean ± SD age for NAION cases at the index date was 64.0±9.2 years vs. 58.4±9.4 years for the remainder of the beneficiaries. After adjustment for confounding factors, each additional year older was associated with a 2% increased hazard of NAION (HR = 1.02; 95% CI: 1.01-1.03). Female subjects had a 36% decreased hazard of developing NAION (HR = 0.64; 95% CI: 0.55-0.74) compared with male subjects. Compared with whites, Latinos had a 46% decreased hazard of developing NAION (HR = 0.54; 95% CI: 0.36-0.82), whereas African ancestry was not significantly associated with NAION (HR = 0.91; 95% CI: 0.72-1.15). Systemic diseases associated with NAION included hypertension (HR = 1.62; 95% CI: 1.26-2.07) and hypercoagulable states (HR = 2.46; 95% CI: 1.51-4.00). Although diabetes mellitus (DM) was not significantly associated with NAION compared with those without DM (P = 0.45), patients with end-organ involvement from DM had a 27% increased hazard of NAION relative to those with uncomplicated DM (HR = 1.27; 95% CI: 1.01-1.59). Ocular diseases associated with NAION were age-related macular degeneration (HR = 1.29; 95% CI: 1.08-1.54) and retinal vein occlusion (HR = 3.94; 95% CI: 3.11-4.99). CONCLUSIONS: Our study identified several modifiable risk factors that may be associated with NAION. Should future studies confirm these findings, they may offer opportunities to prevent or treat this debilitating condition.

Patterns of Glaucoma Medication Adherence over Four Years of Follow-Up.

PURPOSE: To assess longer-term patterns of glaucoma medication adherence and identify whether patterns established during the first year of medication use persist during 3 subsequent years of follow-up. DESIGN: Retrospective, longitudinal cohort analysis. PARTICIPANTS: Beneficiaries aged ≥40 years who were enrolled in a United States (US)-managed care plan for ≥7 years between 2001 and 2012 and newly diagnosed and treated for open-angle glaucoma. METHODS: For each enrollee, we quantified medication adherence using the medication possession ratio. Group-based trajectory modeling (GBTM) was applied to identify patterns of adherence for 1 and 4 years of follow-up. The percent of beneficiaries who remained in the same trajectory group in the 1- and 4-year models was tabulated to evaluate group stability. Factors impacting adherence at 1 and 4 years were identified using regression analyses. MAIN OUTCOME MEASURES: Patterns of glaucoma medication adherence. RESULTS: Of the 1234 eligible beneficiaries, GBTM identified 5 distinct glaucoma medication adherence patterns in both the 1-year and 4-year follow-up periods. These groups were as follows: (1) never adherent after their index prescription fill (7.5% and 15.6% of persons in the 1- and 4-year models, respectively); (2) persistently very poor adherence (14.9% and 23.4% of persons in the 1- and 4-year models, respectively); (3) declining adherence (9.5% and 9.1% of persons in the 1- and 4-year models, respectively); (4) persistently moderate adherence (48.1% and 37.0% of persons in the 1- and 4-year models, respectively); and (5) persistently good adherence (20.0% and 15.0% of persons in the 1- and 4-year models, respectively). More than 90% of beneficiaries in the 4 groups with the worst and best adherence patterns (groups 1, 2, 3, 5) maintained their patterns from their first year throughout their 4 years of follow-up. Those with persistently moderate adherence (group 4), the largest group, were most likely to change groups from 1 to 4 years of follow-up. Persons with the best adherence over 4 years were more likely to be white, to be older, to earn >$60 000/year, and to have more eye care visits (P < 0.05 for all comparisons). Those with a higher initial copayment cost had lower adherence rates (ß = -0.06/dollar, P = 0.03). CONCLUSIONS: For most patients who were newly prescribed glaucoma medications, adherence patterns observed in the first year of treatment reflect adherence patterns over the subsequent 3 years. Investing resources in both identifying and helping patients with suboptimal adherence patterns over the first year may have a large impact on longer-term adherence.

The Most Common Barriers to Glaucoma Medication Adherence: A Cross-Sectional Survey.

PURPOSE: To evaluate the frequency of 11 commonly cited barriers to optimal glaucoma medication adherence among glaucoma patients and to identify barriers contributing to poor adherence. DESIGN: Prospective, cross-sectional survey. PARTICIPANTS: One hundred ninety adults with glaucoma taking 1 or more glaucoma medication who received care in glaucoma clinics in Ann Arbor, Michigan, and Baltimore, Maryland. METHODS: Participants completed a survey on demographic and disease characteristics, barriers to optimal glaucoma medication adherence, interest in an eye drop aid, and self-reported adherence (measured by the Morisky Adherence Scale). Descriptive statistics and logistic regression analyses were performed. MAIN OUTCOME MEASURES: Frequency and number of barriers to adherence among both adherent and nonadherent patients. Odds ratios (ORs) with 95% confidence intervals (CIs) identifying barriers associated with poor adherence. RESULTS: Twenty-seven percent of the sample reported poor adherence. Sixty-one percent of all participants cited multiple barriers and 10% cited a single barrier as impediments to optimal adherence. Twenty-nine percent of subjects cited no barriers, although only 13% of patients who cited no barriers were nonadherent. Among nonadherent patients, 31% or more cited each of the 11 barriers as important. Logistic regression analysis, adjusted for age, revealed that the following barriers were associated with higher odds of nonadherence: decreased self-efficacy (OR, 4.7; 95% CI, 2.2-9.7; P ≤ 0.0001), difficulty instilling drops (OR, 2.3; 95% CI, 1.1-4.9; P = 0.03), forgetfulness (OR, 5.6; 95% CI, 2.6-12.1; P ≤ 0.0001), and difficulties with the medication schedule (OR, 2.9; 95% CI, 1.4-6.0; P = 0.006). For each additional barrier cited as important, there was a 10% increased odds of being nonadherent (OR, 1.1; 95% CI, 1.0-1.2; P = 0.01). CONCLUSIONS: Each of the 11 barriers was important to at least 30% of surveyed patients with poor adherence, with most identifying multiple barriers to adherence. Low self-efficacy, forgetfulness, and difficulty with drop administration and the medication schedule were barriers associated with poor adherence. Interventions to improve medication adherence must address each patient's unique set of barriers.

Eye care providers' attitudes towards tele-ophthalmology.

BACKGROUND: The rapid rise of e-health and remote care systems will likely change the practice patterns of ophthalmologists. Although telemedicine practices are thriving in many specialties of medicine, telemedicine for ophthalmology has been limited primarily to asynchronous care for diabetic retinopathy. The goal of this research was to evaluate perspectives on and familiarity with telemedicine among eye care providers at a large tertiary-care medical center via an anonymous, descriptive survey. RESULTS: In total, 58 eye care physicians completed surveys (response rates of 86% for physicians-in-training and 49% for faculty physicians, respectively). Although a majority of both faculty and physicians-in-training were willing to participate in telemedicine services, trainees were more likely to be willing to interpret photographs than faculty (p=0.04). Most respondents (71%) indicated that they did not use telemedicine. Over half had received photographs (via phone or e-mail) for interpretation from referring physicians (54%) or patients (56%) within the past 3 months. A majority of providers (82%) would be willing to participate in telemedicine for consultations and for interpreting photographs, but a majority (59%) had low confidence in remote care for providing an opinion on patient care. CONCLUSIONS: Most eye care providers viewed telemedicine as part of the future of eye care but were concerned about the use of telemedicine. Although most providers did not practice telemedicine, over half of them were comfortable managing eye care consultations (including patients' photographs) via the Internet.

Effectiveness of Tofacitinib in Patients Initiating Therapy for Psoriatic Arthritis: Results from the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry.

INTRODUCTION: Randomized controlled trials have demonstrated tofacitinib efficacy for psoriatic arthritis (PsA); however, real-world effectiveness data are limited. This real-world analysis assessed baseline demographics/disease characteristics and tofacitinib effectiveness in patients with PsA in the CorEvitas PsA/Spondyloarthritis Registry. METHODS: This study (NCT05195814) included patients with PsA initiating tofacitinib from December 2017-December 2021, as monotherapy or with oral small molecules (methotrexate/leflunomide/sulfasalazine/apremilast), pre-existing use, or initiated concurrently. OUTCOMES: mean change from baseline in disease activity/patient-reported outcomes, proportion of patients achieving low disease activity (LDA)/remission at 6 ± 3 months, and discontinuation rates. RESULTS: Of 222 patients with PsA who initiated tofacitinib (60.8% as monotherapy), 123 patients had 6 ± 3 months of follow-up. At initiation, 59.7% were female, 92.3% were White, mean age was 56.3 years, PsA duration since diagnosis was 8.2 years, and 25.7% were biologic disease-modifying antirheumatic drug (bDMARD)-naïve. Improvements to 6 ± 3 months were observed with tofacitinib for Clinical Disease Activity Index for PsA (cDAPSA), DAPSA, PsA Disease Activity Score (PASDAS), Clinical Disease Activity Index, body surface area (BSA), tender/swollen joint count, patient fatigue, pain, Patient Global Skin Assessment, and Health Assessment Questionnaire-Disability Index. At 6 ± 3 months, 25.0%/7.8% of patients treated with tofacitinib achieved cDAPSA-defined LDA/remission, 18.2% achieved minimal disease activity, 30.8% had PASDAS ≤ 3.2, 42.9%/29.4% had resolved enthesitis/dactylitis, and 22.5% achieved BSA = 0%. Tofacitinib discontinuation occurred in 51.2% of patients (51.6% of monotherapy initiators) at/prior to 6 ± 3 months (27.6%/23.6%), 57.1% of whom switched to tumor necrosis factor/interleukin-17 inhibitors. Reasons for discontinuation were not reported in 85.3%/79.3% of patients who discontinued at/prior to 6 ± 3 months. CONCLUSIONS: This real-world US cohort analysis described patients with PsA newly initiating tofacitinib; most were bDMARD-experienced or receiving monotherapy treatment. In patients who remained on therapy (48.8%), tofacitinib was effective across multiple PsA domains at 6 ± 3 months. Limitations included small patient numbers at follow-up and potential selection bias. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT05195814.

Disparities in burden of disease in patients with rheumatoid arthritis across racial and ethnic groups.

To examine racial/ethnic differences in rheumatoid arthritis (RA) disease burden and change in clinical outcomes over time. We included CorEvitas Rheumatoid Arthritis Registry patients from two time periods (2013-2015 and 2018-2020). Clinical Disease Activity Index (CDAI) (as a continuous measure and as a dichotomous measure) and the Health Assessment Questionnaire-Disability Index (HAQ-DI) were assessed at each visit. Marginal means and their corresponding 95% confidence interval (CI) by race/ethnicity were estimated for each outcome using adjusted mixed effects linear and logistic regression models. Overall and pairwise tests were conducted to detect differences between race/ethnicity groups. Of 9,363 eligible patients (8,142 White, 527 Black, 545 Hispanic, 149 Asian), most (76%-85%) were female. At Visit 1, the mean disease duration ranged from 9.8-11.8 years. Estimated CDAI was significantly higher for Hispanics compared to Whites at Visit 1 (11.1 vs. 9.9; pairwise P = 0.033) and Visit 2 (9.2 vs. 8.0, pairwise P = 0.005). Disease activity improved over the 5-year study period among all race/ethnicity groups, though Hispanics improved less than Whites. Disease activity improved over the 5-year period across all racial/ethnicity groups, and disparities between racial/ethnicity groups in disease activity and functional status did persist over time, suggesting that further effort is needed to understand the drivers of these discrepancies to close this race/ethnicity gap. Key Points • Disease activity improved over the 5-year period across all racial and ethnic groups. • Disparities between racial and ethnic groups in disease activity and functional status did persist over time, suggesting that further effort is needed to understand the drivers of these discrepancies and close this racial gap.

Effectiveness of bDMARDs in ankylosing spondylitis patients by biologic use: experience from the CorEvitas PsA/SpA Registry.

OBJECTIVE: To describe bDMARD initiators by biologic experience among ankylosing spondylitis (AS) patients and change in disease activity and patient-reported outcomes (PROs) in real-world US patients. METHODS: We included patients ≥18 years with AS based on physician diagnosis enrolled between 3/2013 and 11/2019 in the CorEvitas Psoriatic Arthritis (PSA)/Spondyloarthritis Registry (NCT02530268). Patients concurrently diagnosed with PSA were excluded. Baseline (bDMARD initiation) demographics, comorbidities, disease characteristics, treatment, and PROs were collected. Response rates and changes in disease activity and PROs between baseline and 6- and 12- month follow-up visits were calculated. RESULTS: Of the 489 AS patients in the PsA/SpA Registry, 254 AS (52.0%) patients initiated a bDMARD at enrollment or during follow-up (total initiations: AS = 313). Of the 313 AS initiations, 179 (57.2%) had a 6-month follow-up, 122 (39.0%) had a 12-month follow-up, and 94 (30.0%) had a 6- and 12-month follow-up visit. For those AS initiators with a 6-month follow-up, the mean age was 49.1 years, 44.4% were female, and 70.4%, 47.5%, 96.1%, and 46.9% had never used cDMARDs, TNFis, non-TNFis, and bDMARDs, respectively. Of these 179 AS initiators, 20.1% and 14.0% achieved ASAS20/40, respectively. Further, only 34% achieved low disease activity (ASDAS <2.1). When stratified by biologic-naivete and biologic-experience, the ASAS 20/40 achievement rates were 26.2% and 14.7%, and 21.4% and 7.4%, respectively, for this cohort. CONCLUSION: Although AS patients initiate bDMARDs, many do not achieve optimal treatment responses. Future research is needed to investigate the aspects associated with inadequate improvement and treatment response to bDMARDs.

Comparative effectiveness of TNF inhibitor vs IL-6 receptor inhibitor as monotherapy or combination therapy with methotrexate in biologic-experienced patients with rheumatoid arthritis: An analysis from the CorEvitas RA Registry.

OBJECTIVE: Randomized controlled trials (RCTs) in biologic-naïve rheumatoid arthritis (RA) patients with high disease activity and inadequate response/intolerance to methotrexate have shown interleukin-6 (IL-6) receptor inhibitors (IL-6Ri) to be superior to tumor necrosis factor inhibitors (TNFi) as monotherapy. This observational study aimed to compare the effectiveness of TNFi vs IL-6Ri as mono- or combination therapy in biologic/targeted synthetic (b/ts) -experienced RA patients with moderate/high disease activity. METHODS: Eligible b/ts-experienced patients from the CorEvitas RA registry were categorized as TNFi and IL-6Ri initiators, with subgroups initiating as mono- or combination therapy. Mixed-effects regression models evaluated the impact of treatment on Clinical Disease Activity Index (CDAI), patient-reported outcomes, and disproportionate pain (DP). Unadjusted and covariate-adjusted effects were reported. RESULTS: Patients initiating IL-6Ri (n = 286) vs TNFi monotherapy (n = 737) were older, had a longer RA history and higher baseline CDAI, and were more likely to initiate as third-line therapy; IL-6Ri (n = 401) vs TNFi (n = 1315) combination therapy initiators had higher baseline CDAI and were more likely to initiate as third-line therapy. No significant differences were noted in the outcomes between TNFi and IL-6Ri initiators (as mono- or combination therapy). CONCLUSION: This observational study showed no significant differences in outcomes among b/ts-experienced TNFi vs IL-6Ri initiators, as either mono- or combination therapy. These findings were in contrast with the previous RCTs in biologic-naïve patients and could be explained by the differences in the patient characteristics included in this study. Further studies are needed to help understand the reasons for this discrepancy in the real-world b/ts-experienced population.

Clinical Outcomes in Patients with Rheumatoid Arthritis After Switching Between Interleukin-6-Receptor Inhibitors and Janus Kinase Inhibitors: Findings from an Observational Study.

INTRODUCTION: This observational study evaluated response in patients with rheumatoid arthritis (RA) who switched from an interleukin-6 receptor inhibitor (IL-6Ri) to a Janus kinase inhibitor (JAKi) and vice versa. METHODS: Adult patients with RA, who initiated IL-6Ri or JAKi (following discontinuation of JAKi or IL-6Ri, respectively) during/after December 2012 and had a 6-month follow-up visit were enrolled. Clinical outcomes were evaluated at baseline and the follow-up visit. Continuous outcomes included Clinical Disease Activity Index (CDAI), Health Assessment Questionnaire (HAQ), pain, fatigue, tender joint count, swollen joint count, Physician Global Assessment (MDGA), Patient Global Assessment (PtGA), and morning stiffness duration. Categorical outcomes included the proportion of patients achieving CDAI low disease activity (LDA), remission, and minimal clinically important differences (MCIDs) for HAQ, pain, fatigue, MDGA, and PtGA. Continuous outcomes were summarized as mean changes from baseline, and categorical outcomes as response rates. Differences in the outcome measures between groups were evaluated using linear and logistic regression models. RESULTS: Between IL-6Ri (n = 100) and JAKi initiators (n = 129), no significant differences were noted for continuous outcomes. Within both groups, a significant proportion of patients achieved LDA, remission, and MCIDs for other measures, although the odds of achieving LDA were higher among IL-6Ri (vs. JAKi) initiators with moderate-to-severe disease (adjusted odds ratio: 3.30 [1.01, 10.78]). CONCLUSIONS: Patients with RA can achieve improvement in response when switching between IL-6Ri and JAKi. Although both therapies affect the IL-6 pathway, there are distinct mechanisms of action, which likely contribute to their clinical improvement, when reciprocally switched as follow-on treatments.

A Real-World Effectiveness Study Using a Mobile Application to Evaluate Early Outcomes with Upadacitinib in Rheumatoid Arthritis.

INTRODUCTION: The impact of upadacitinib on rheumatoid arthritis (RA) symptoms was evaluated during the first 12 weeks of treatment via patient-reported outcomes (PROs) using a mobile health application (app). METHODS: Participating rheumatologists from the CorEvitas RA Registry (prospective, observational cohort) recruited patients with RA initiating upadacitinib treatment. A modified version of the ArthritisPower® app was used to collect PROs, including the Routine Assessment of Patient Index Data 3 (RAPID3), duration of morning joint stiffness, and the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue 7a Short Form at baseline and weeks 1-4, 8, and 12. RAPID3 responses over time were assessed using Kaplan-Meier estimation to determine the proportion of patients achieving disease activity improvement and minimal clinically important difference (MCID). Results were analyzed for all patients initiating upadacitinib and a subsample of TNF inhibitor (TNFi)-experienced patients with moderate to severe disease at baseline. RESULTS: A total of 103 patients with RA initiating upadacitinib (62.1% TNFi-experienced) were included. At week 12, 53 patients (51.4%) completed the study and provided PRO data via the app. Among all patients, improvements in RAPID3, pain, morning stiffness, and fatigue were observed at week 1 and were maintained or further improved through week 12. At week 12, 37.5% of patients achieved RAPID3 low disease activity. Starting at week 1, improvements in RAPID3 disease activity category (19.4% of patients) and achievement of MCID (16.3%) were reported, with nearly 50% of patients achieving these outcomes by week 4 (RAPID3 category: 48.8%; MCID: 49.2%) and 60% by week 12 (RAPID3 category: 59.6%; MCID: 59.8%). TNFi-experienced patients generally reported similar outcomes. Patient-reported medication convenience and compliance were generally high. CONCLUSIONS: In this real-world cohort of patients with RA, treatment with upadacitinib was associated with early and significant improvement in RAPID3, pain, morning stiffness, and fatigue regardless of prior TNFi experience. Clinically meaningful improvement in RAPID3 patient-reported disease activity was observed as early as week 1, with continued improvement reported through week 12.

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

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