Jinender Kumar

An unmet need exists for patients with relapsed/refractory (R/R) follicular lymphoma (FL) and high-risk disease features, such as progression of disease within 24 months (POD24) from first-line immunochemotherapy or disease refractory to both CD20-targeting agent and alkylator (double refractory), due to no established standard of care and poor outcomes. Chimeric antigen receptor (CAR) T cell therapy is an option in R/R FL after two or more lines of prior systemic therapy, but there is no consensus on its optimal timing in the disease course of FL, and there are no data in second-line (2L) treatment of patients with high-risk features. Lisocabtagene maraleucel (liso-cel) is an autologous, CD19-directed, 4-1BB CAR T cell product. The phase 2 TRANSCEND FL study evaluated liso-cel in patients with R/R FL, including 2L patients who all had POD24 from diagnosis after treatment with anti-CD20 antibody and alkylator ≤6 months of FL diagnosis and/or met modified Groupe d'Etude des Lymphomes Folliculaires criteria. Primary/key secondary endpoints were independent review committee-assessed overall response rate (ORR)/complete response (CR) rate. At data cutoff, 130 patients had received liso-cel (median follow-up, 18.9 months). Primary/key secondary endpoints were met. In third-line or later FL (n = 101), ORR was 97% (95% confidence interval (CI): 91.6‒99.4), and CR rate was 94% (95% CI: 87.5‒97.8). In 2L FL (n = 23), ORR was 96% (95% CI: 78.1‒99.9); all responders achieved CR. Cytokine release syndrome occurred in 58% of patients (grade ≥3, 1%); neurological events occurred in 15% of patients (grade ≥3, 2%). Liso-cel demonstrated efficacy and safety in patients with R/R FL, including high-risk 2L FL. ClinicalTrials.gov identifier: NCT04245839 .

The objective of this prospective, pre-post longitudinal study was to assess the impact of pharmacist-provided medication therapy management (MTM) services on employees' health and well-being by evaluating their clinical and humanistic outcomes. City of Toledo employees and/or their spouses and dependents with diabetes with or without comorbid conditions were enrolled in the pharmacist-conducted MTM program. Participants scheduled consultations with the pharmacist at predetermined intervals. Overall health outcomes, such as clinical markers, health-related quality of life (HRQoL), disease knowledge, and social and process measures, were documented at these visits and assessed for improvement. Changes in patient outcomes over time were analyzed using Wilcoxon signed rank and Friedman test at an a priori level of 0.05. Spearman correlation was used to measure the relationship between clinical and humanistic outcomes. A total of 101 patients enrolled in the program. At the end of 1 year, patients' A1c levels decreased on average by 0.27 from their baseline values. Systolic and diastolic blood pressure also decreased on average by 6.0 and 4.2 mmHg, respectively. Patient knowledge of disease conditions and certain aspects or components of HRQoL also improved. Improvements in social and process measures also were also observed. Improved clinical outcomes and quality of life can affect employee productivity and help reduce costs for employers by reducing disease-related missed days of work. Employers seeking to save costs and impact productivity can utilize the services provided by pharmacists.

Objective This systematic literature review (SLR) assessed the effects of endoscopic mucosal healing and histologic remission on clinical, quality-of-life (QoL), and economic outcomes in adults with ulcerative colitis (UC) in the real-world setting.Methods Literature searches of Embase and MEDLINE (6 July 2020) and conference proceedings (2017–2020) were performed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Eligible studies included adults with UC with documented endoscopic mucosal healing or histologic remission. Clinical, QoL, and economic outcomes were extracted and narratively synthesized.Results Of 1603 studies screened, 25 met eligibility criteria and collectively included 2813 patients (mean age: 34–60 years). The most commonly reported indices were Mayo endoscopic score (MES) for endoscopic mucosal healing (n = 22, 88%) and Geboes score (n = 5, 20%) for histologic outcomes. The most frequently reported clinical outcome was relapse-free survival (n = 15, 60%). Less commonly reported outcomes were avoidance of colectomy (n = 5, 20%), hospitalization (n = 4, 16%), clinical remission (n = 4, 16%), and steroid-free clinical remission (n = 3, 12%). Most studies reported relapse-free survival rates up to 50% over 6–48 months of follow-up in endoscopic mucosal healing cohorts. Studies reporting results by MES demonstrated higher relapse-free survival rates among patients with MES 0 than with MES 1 (32%–100% vs 26%–86%, respectively). Similarly, patients with histologic remission had better relapse-free survival rates over 12–24 months of follow-up compared with those without histologic remission (72%–91% vs 40%–63%, respectively). Rates of clinical remission, steroid-free remission, hospitalization, and colectomy avoidance were also better among patients with endoscopic mucosal healing and histologic remission. Two studies examining QoL reported endoscopic mucosal healing was associated with improved QoL. No study reported economic outcomes.Conclusions This SLR demonstrated consistent evidence of improved clinical outcomes among UC patients with endoscopic mucosal healing and histologic remission.

Background: Currently approved biologic therapies for moderate-to-severe ulcerative colitis have well-established efficacy. However, many patients fail to respond or lose response, leading to dose escalation or treatment switching. Objective: We sought to identify real-world evidence on dose escalation and treatment switching and associated clinical and economic outcomes among adults with ulcerative colitis treated with infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, or tofacitinib. Methods: We conducted a systematic search of Embase, MEDLINE (up to 26 August 2020), and conference proceedings (2017-2020) for studies in adults with ulcerative colitis to assess clinical response and remission, colectomy, adverse events, and economic outcomes related to dose escalation and treatment switching. Results: In 56 studies, dose escalation and treatment switching involving infliximab and/or adalimumab were most frequently investigated. Rates of clinical response after dose escalation were 20-95% (1.8-36 months), clinical remission rates were 10-94% (1.8-36 months), colectomy rates were 0-33% (12-38 months), and adverse event rates were 0-18%. Treatment switching rates in 21 studies were 4-70% over 3-62 months, with switch due to loss of response rates of 4-35% over 12-62 months (7 studies). Up to 35% of patients underwent colectomy 12-120 weeks after switching, and 13-38% experienced adverse events. Data relating to economic outcomes were limited to tumor necrosis factor inhibitors, but demonstrated increased direct costs associated with both dose escalation and treatment switching. Conclusion: Dose escalation and treatment switching are common with existing therapies. However, clinical response and remission rates vary, and a proportion of patients fail to achieve optimal clinical and economic outcomes. This highlights the need for more efficacious and durable treatments for patients with moderate-to-severe ulcerative colitis.

BACKGROUND: The purpose of this study was to determine the cost savings of a pharmacist-led, employer-sponsored medication therapy management (MTM) program for diabetic patients and to assess for any changes in patient satisfaction and self-reported medication adherence for enrollees. METHODS: Participants in this study were enrollees of an employer-sponsored MTM program. They were included if their primary medical insurance and prescription coverage was from the City of Toledo, they had a diagnosis of type 2 diabetes, and whether or not they had been on medication or had been given a new prescription for diabetes treatment. The data were analyzed on a prospective, pre-post longitudinal basis, and tracked for one year following enrollment. Outcomes included economic costs, patient satisfaction, and self-reported patient adherence. Descriptive statistics were used to characterize the population, calculate the number of visits, and determine the mean costs for each visit. Friedman's test was used to determine changes in outcomes due to the nonparametric nature of the data. RESULTS: The mean number of visits to a physician's office decreased from 10.22 to 7.07. The mean cost of these visits for patients increased from $47.70 to $66.41, but use of the emergency room and inpatient visits decreased by at least 50%. Employer spending on emergency room visits decreased by $24,214.17 and inpatient visit costs decreased by $166,610.84. Office visit spending increased by $11,776.41. A total cost savings of $179,047.80 was realized by the employer at the end of the program. Significant improvements in patient satisfaction and adherence were observed. CONCLUSION: Pharmacist interventions provided through the employer-sponsored MTM program led to substantial cost savings to the employer with improved patient satisfaction and adherence on the part of employees at the conclusion of the program.