Perspectives on Treatment Burden for Methotrexate and Tumor Necrosis Factor Inhibitors Among Patients With Psoriatic Arthritis and Rheumatoid Arthritis: A Qualitative Study.

OBJECTIVE: To describe patients' perspectives on the burden associated with methotrexate (MTX) or tumor necrosis factor inhibitor (TNFi) use in psoriatic arthritis (PsA) and rheumatoid arthritis (RA). METHODS: Between May 2019 and March 2020, patients receiving MTX and/or a TNFi for either PsA or RA were randomly sampled from the FORWARD data bank and were invited to participate in semistructured telephone interviews. Interviews explored patients' perspectives on treatment burden and experiences with MTX and TNFi and were conducted until data saturation was achieved. Interviews were recorded, transcribed, and analyzed using a grounded theory approach and NVivo v12.0 software. RESULTS: Overall, 25 patients with PsA and 24 patients with RA participated in the interviews. Participants were predominantly women (mean age: 67 years). Nine major themes related to treatment burden were explored, including treatment side effects and their management, psychological burden, effect on daily functioning and work participation, challenges with accessing and administering therapies, financial difficulties or economic impact, and family planning or breastfeeding. Patients receiving MTX mostly reported side effects as the major burden, while cost and concerns with accessing and administering medication were major challenges reported by TNFi users. Treatment discontinuation due to lack of effectiveness was high for PsA, while discontinuation due to medication cost was high for RA. CONCLUSION: Patients experience a wide range of burden associated with treatments used for PsA and RA. Health care practitioners should consider these challenges when prescribing therapy and strive toward reducing this burden by understanding patients' concerns and needs and involving them in decision making.

Estimating the impact of biosimilar entry on prices and expenditures in rheumatoid arthritis: a case study of targeted immune modulators.

OBJECTIVE: To model changes in prices, utilization, and expenditures of targeted immune modulators (TIMs) for rheumatoid arthritis, accounting for biosimilar entry. METHODS: Using IQVIA National Sales Perspective data between 2013 and 2019, we examined sales and expenditures of biologics and non-biological complex molecules, 20 quarters before and after patent exclusivity milestones. We estimated the impact of a molecule's exclusivity milestones and biosimilar entry on prices, using a regression discontinuity design (RDD). We then combined the RDD estimate with historical trends to assess the impact of adalimumab's exclusivity milestones on future TIM expenditures. RESULTS: Changes in average molecule prices were associated largely with biosimilar uptake. For molecules with relatively high biosimilar uptake (>60%), prices fell considerably (-21.2% to -59.3%) one year after exclusivity milestones, whereas molecules with lower biosimilar uptake (<10%) experienced smaller price decreases (-2.4% to -8.4%). Average price reduction at the molecule level after biosimilar entry was not significant (-18.6%; p = .657). When applying the RDD results after adalimumab's exclusivity milestones, its projected share of total TIM market expenditures decreased from 48.0% in 2019 to 26.0% in 2025, whereas expenditures on Janus kinase inhibitors increased from 4.0% to 34.0%. CONCLUSIONS: Biologics facing biosimilar competition may experience price decreases, potentially offering substantial savings to payers, patients, and society, although the magnitude of these estimates depends on biosimilar uptake. Formulary placement, along with manufacturer-payer dynamics, may also play a role in determining the impact on price and market uptake of biosimilars.

Side Effects of Methotrexate and Tumor Necrosis Factor Inhibitors: Differences in Tolerability Among Patients With Psoriatic Arthritis and Rheumatoid Arthritis.

OBJECTIVE: To examine the prevalence of side effects with methotrexate (MTX) and tumor necrosis factor inhibitors (TNFi) among patients with psoriatic arthritis (PsA) and rheumatoid arthritis (RA). METHODS: This retrospective analysis, conducted between January 2000 and January 2019, used data from the FORWARD databank. Adult patients enrolled in the registry with self-reported and physician-confirmed diagnosis of PsA or RA were included if they had completed at least one questionnaire before initiating and within 12 months following initiation of MTX or a TNFi. The primary outcome was to examine the prevalence of side effects with MTX and TNFi within the year following treatment initiation. Multivariate logistic regression analysis was performed to examine the association between PsA and RA and the reporting of their side effects. RESULTS: Overall, 116 patients with PsA and 4247 patients with RA newly initiated MTX, and 124 patients with PsA and 4361 patients with RA newly initiated a TNFi. Patients with PsA were more likely to report MTX-related side effects than those with RA (44.8% vs. 29.4%), whereas similar proportions of patients with PsA and RA reported TNFi-related side effects within the first year (24.2% and 22.8%, respectively). Additionally, patients with PsA initiating MTX were more likely to report nausea, vomiting, abdominal pain, depression, and tinnitus than patients with RA initiating MTX or those with PsA or RA initiating a TNFi. CONCLUSION: Patients with PsA reported more side effects than patients with RA, and this difference was more pronounced in those receiving MTX versus TNFi.

Identifying chronic disease patients using predictive algorithms in pharmacy administrative claims: an application in rheumatoid arthritis.

OBJECTIVE: To evaluate the predictive performance of logistic and linear regression versus machine learning (ML) algorithms to identify patients with rheumatoid arthritis (RA) treated with target immunomodulators (TIMs) using only pharmacy administrative claims. METHODS: Adults aged 18-64 years with ≥1 TIM claim in the IBM MarketScan commercial database were included in this retrospective analysis. The predictive ability of logistic regression to identify RA patients was compared with supervised ML classification algorithms including random forest (RF), decision trees, linear support vector machines (SVMs), neural networks, naïve Bayes classifier, linear discriminant analysis (LDA), quadratic discriminant analysis (QDA), and K-nearest neighbors (k-NN). Model performance was evaluated using F1 score, accuracy, precision, sensitivity, area under the receiver operating characteristic curve (AUROC), and Matthews correlation coefficient (MCC). Analyses were conducted in all-patient and etanercept-only samples. RESULTS: In the all-patients sample, ML approaches did not outperform logistic regression. RF showed small improvements versus logistic regression that were not considered remarkable, respectively: F1 score (84.55% vs 83.96%), accuracy (84.05% vs 83.79%), sensitivity (84.53% vs 82.20%), AUROC (84.04% vs 83.85%), and MCC (68.07% vs 67.66%). Findings were similar in the etanercept samples. CONCLUSION: Logistic regression and ML approaches successfully identified patients with RA in a large pharmacy administrative claims database. The ML algorithms were no better than logistic regression at prediction. RF, SVMs, LDA, and ridge classifier showed comparable performance, while neural networks, decision trees, naïve Bayes classifier, and QDA underperformed compared with logistic regression in identifying patients with RA.

Association of physician specialty with psoriatic arthritis treatment and costs.

OBJECTIVES: To describe current psoriatic arthritis treatment and costs by provider specialty using real-world claims data. STUDY DESIGN: Observational, retrospective cohort study of patients in the IBM MarketScan Commercial and supplemental Medicare databases. METHODS: Eligible patients had newly diagnosed psoriatic arthritis with 12 months of continuous enrollment pre- and post index date for their initial claim. Patients were assigned to 1 of 5 provider specialty cohorts. During the 1-year follow-up period, we collected psoriatic arthritis treatment agent and regimen type and total annual medical and health care costs. We used multivariate regression models to determine the conditional associations of provider specialty with costs. RESULTS: A total of 2132 patients with incident psoriatic arthritis qualified. Most providers were rheumatologists (n = 1365; 64%). Rheumatologists commonly prescribed oral small molecules (methotrexate, 56.3% of prescriptions; sulfasalazine, 8.6%; apremilast, 7.0%) as the index therapy, whereas 23.8% of prescriptions were for tumor necrosis factor inhibitors (adalimumab, 14.2%; etanercept, 7.9%; and infliximab, 1.7%). Compared with other specialists, dermatologists prescribed biologics and other specialty drugs more frequently-adalimumab (32.7%), apremilast (14.3%), etanercept (11.6%), and ustekinumab (8.8%)-and methotrexate less frequently (30.6%). The greatest unadjusted median health care costs were observed among dermatologists ($45,548) compared with rheumatologists ($30,411), primary care physicians ($29,927), rheumatologists/dermatologists ($27,393), and other specialists ($27,774). However, after adjusting for patient-level factors, multivariate regression analyses found that provider specialty was not associated with higher health care costs. CONCLUSIONS: In patients with newly diagnosed psoriatic arthritis, physician specialty was associated with different medication choices but not costs.

Patient-reported outcomes data in patients with psoriatic arthritis from a randomised trial of etanercept and methotrexate as monotherapy or in combination.

OBJECTIVES: We examined patient-reported outcomes (PROs) in The Study of Etanercept And Methotrexate in Patients with Psoriatic Arthritis (PsA); a 48-week, phase 3, randomised controlled trial that compared outcomes with methotrexate (MTX) monotherapy, etanercept monotherapy, and MTX+ etanercept in patients with PsA. METHODS: Efficacy endpoints included: mean changes from baseline and proportion of patients who reported improvements≥minimal clinically important difference (MCID) at week 24 in treatment groups for Health Assessment Questionnaire-Disability Index, Patient Global Assessment (PtGA), Patient Global Assessment of Joint Pain (PtGAJP) and Medical Outcomes Study Short Form-36 Questionnaire (SF-36) Physical Component Summary (PCS), and Mental Component Summary, and eight domain scores. PROs were analysed as reported (observed), without multiplicity adjustment; therefore, p values are descriptive. RESULTS: At week 24, patients receiving etanercept monotherapy or MTX+ etanercept combination reported greater improvements (p≤0.05) in PtGA, PtGAJP and SF-36 PCS scores compared with those receiving MTX monotherapy. Compared with MTX monotherapy, higher proportions of patients receiving etanercept monotherapy and combination therapy reported improvements≥MCID in PtGA (etanercept vs MTX, p=0.005) and PtGAJP (MTX +etanercept vs MTX, p=0.038). Across PROs, proportions of patients reporting scores≥age and gender-matched normative values at week 24 ranged from 20.8% to 51.0% with MTX monotherapy, 30.9% to 48.8% with etanercept monotherapy, and 30.6% to 52.3% with MTX+ etanercept combination. CONCLUSIONS: Patients receiving etanercept monotherapy or MTX+ etanercept reported greater improvements from baseline in several PROs compared with those receiving MTX monotherapy. PROs should be incorporated in discussions between patients and clinicians regarding their treatment choices as they can help determine which treatments are more beneficial in patients with PsA.

Psoriatic arthritis treatment patterns and costs among pharmacologic treatment-naïve patients.

OBJECTIVES: Pharmacologic treatment for psoriatic arthritis (PsA) includes traditional oral small molecules (OSMs), tumor necrosis factor inhibitors (TNFis), and newer oral therapies such as a phosphodiesterase-4 (PDE4) inhibitor and a Janus kinase inhibitor. We aimed to describe treatment patterns and health care costs for treatment-naïve patients with active PsA initiating pharmacologic treatment. STUDY DESIGN: This was an observational, retrospective study. METHODS: We assessed treatment patterns and health care costs from the IBM MarketScan Research databases. We calculated costs during the 12-month follow-up period for inpatient and outpatient medical health care, including outpatient prescription costs. RESULTS: A total of 3491 patients were identified for the study. Incident therapies included OSMs methotrexate (58.3%), sulfasalazine (9.8%), hydroxychloroquine (2.3%), and other OSMs (1.9%); TNFis adalimumab (12.3%), etanercept (8.6%), infliximab (1.9%), and other TNFis (1.4%); and the PDE4 inhibitor apremilast (2.6%). Persistence ranged from 15.2% to 34.6% with OSM monotherapy and from 42.9% to 58.2% with TNFi monotherapy. Percentage of patients with a gap of at least 60 days in therapy ranged from 42.9% to 48.5% with OSMs and from 17.9% to 29.9% with TNFis. Mean first-line unadjusted per-patient per-month total health care costs for OSMs ranged from $1029 to $1456 and mean total health care costs ranged from $19,173 to $25,013. Mean unadjusted per-patient per-month total health care costs for TNFis ranged from $4203 to $7063 and mean total health care costs ranged from $45,635 to $60,933. CONCLUSIONS: Although patients using OSMs had generally lower total health care costs, they also had the highest rates of treatment modifications such as low persistence and medication gaps of at least 60 days.