Impact of brodalumab treatment on psoriasis symptoms and health-related quality of life: use of a novel patient-reported outcome measure, the Psoriasis Symptom Inventory.

BACKGROUND: Psoriasis symptoms have a significant negative impact on health-related quality of life, impairing physical functioning and well-being. OBJECTIVE: To evaluate the impact of brodalumab, a human anti-interleukin-17R monoclonal antibody, on psoriasis symptom severity as measured by a novel patient-reported outcome measure, the Psoriasis Symptom Inventory, and dermatology-specific health-related quality of life as measured by the Dermatology Life Quality Index (DLQI). METHODS: This was a secondary analysis of a phase II, randomized, double-blind, placebo-controlled clinical study of patients with moderate-to-severe psoriasis (n = 198) treated with brodalumab or placebo. This analysis assessed Psoriasis Symptom Inventory scores and DLQI scores over time. Analyses were conducted on all patients who were randomized and received one or more injections of the study drug according to intention to treat using last observation carried forward to impute missing data. RESULTS: At week 12, subjects in the brodalumab groups had significant improvements in mean Psoriasis Symptom Inventory total scores [8.5 (70 mg), 15.8 (140 mg), 16.2 (210 mg) and 12.7 (280 mg)] compared with placebo (4.8). Mean improvements in DLQI were clinically meaningful (≥ 5.7) in the brodalumab groups (6.2, 9.1, 9.6 and 7.1, respectively) and significantly greater than placebo (3.1). Improvements in Psoriasis Symptom Inventory were observed as early as week 2 and in DLQI by week 4. All eight Psoriasis Symptom Inventory item scores improved significantly among the brodalumab groups by week 12. CONCLUSIONS: Results were from a single randomized clinical trial and may not generalize to broader patient populations. However, treatment with brodalumab provided significant improvement in psoriasis symptoms in patients with moderate-to-severe psoriasis.

A cost-benefit analysis of four hormonal contraceptive methods.

This paper presents the results of a cost-benefit analysis conducted for pregnancy prevention treatment with four hormonal methods of contraception using a managed-care viewpoint. The therapies analyzed are medroxy-progesterone acetate injection (Depo-Provera), levonorgestrel subdermal implants (Norplant), progestogenonly oral tablets (Nor-QD), and combination progestogen/estrogen oral tablets (Ortho-Novum 7/7/7). Cost and benefits associated with the use of therapies are identified and analyzed based on the cost per patient-day of effective pregnancy prevention. The analysis demonstrates that all four methods have a positive net benefit, with Depo-Provera having the highest net benefit. This information can provide decision makers within a pharmacy and therapeutics committee of a managed-care organization the framework on which to base formulary decisions.

Conducting clinical and health economic outcome studies in an ambulatory setting.

Increasingly, health care practitioners are addressing economic (health care resource utilization) and nonclinical (patient satisfaction and quality of life) outcomes along with traditional clinical outcomes (morbidities, mortalities, cure rates, etc.) in assessing the impact and quality of care provided to their patients. These additional outcomes also are collected to assist health care providers to meet accreditation standards and to aid in the selection of alternative health care interventions in an environment of limited resources. This article reviews the advantages and disadvantages of assessing both clinical and nonclinical outcomes. A review of key questions that health economic and outcome studies should answer is provided. In addition, relevant resource utilization and outcome measures are identified based on a variety of provider/payer perspectives. Finally, a framework to develop a strategic operating plan for measuring and valuing outcome measures in an ambulatory setting is presented.

A retrospective analysis of the costs and consequences of a tobacco-cessation program for active duty service members.

Health system records of 126 active-duty (AD) service members who were participants in the Davis-Monthan AFB "Quitters are Winners" tobacco cessation program (QAWP) between June 1993 and May 1994 were reviewed retrospectively during the fall of 1994. Participants received an average of 2.84 (+/- 1.46) prescriptions for transdermal nicotine replacement therapy representing 6 weeks duration. Tobacco abstinence, determined by 6-month point prevalence abstinence (PPA), was 19.05 and 15.08% for 6-month continuous abstinence (CA). PPA and CA rates were significantly higher than expected (z = 3.94, p < 0.002; z = 2.38, p < 0.02). Average operational cost per successful outcome at 6 months after entry into the QAWP were $778.93 using PPA and $983.92 using CA. Additional analyses revealed corresponding increases between average cost per successful outcome and duration of TNRT. This research provides an initial analysis of the efficiency of the QAWP for AD participants and a model for subsequent evaluations within military medical treatment facilities.

Use of the Social Health Battery in an elderly population.

The Social Health Battery, a measure of social support developed by Donald and Ware, has only been tested in a population of individuals aged 14 to 61 years. As part of a larger study, the battery was administered to adults aged 61 to 93 years. Internal consistencies, Cronbach coefficient alpha, indicated that the scale and its subscales, Social Contacts and Group Participation, appear to be a reliable measure of social support for a geriatric population.

Factors influencing the delivery of pharmacy services.

This study of 590 community pharmacies examined relationships between prescription payment methods and the number of pharmacy services provided at community pharmacies. Also studied were pharmacists' perceptions regarding: (1) the importance of 24 different pharmacy services, (2) the importance of three motivating factors in providing pharmacy services, (3) satisfaction with three methods of payment for pharmacy services, and (4) agreement with factors cited in the literature as barriers to pharmaceutical care. Results revealed a significant positive relationship (p < 0.05) between the number of pharmacy services provided and the percentage of private-pay prescriptions processed. A significant (p < 0.05) inverse relationship was identified between the number of pharmacy services provided and both the percentage of prescriptions processed for third parties other than Medicaid and the percentage of all third party prescriptions processed. Financial incentives were identified as the most important motivator in providing pharmacy services. Private-pay reimbursement was significantly more satisfactory to respondents than Medicaid reimbursement, and both were more satisfactory than reimbursement by a third party other than Medicaid. The greatest perceived barriers to the provision of pharmacy services involved financial and administrative considerations. Results suggest that financial incentives play a critical role in stimulating the provision of pharmacy services.

Strategic planning in the community pharmacy.

The extent and quality of strategic planning by community pharmacy owners and/or managers was assessed. Also examined were factors that may explain respondents use of the strategic planning process. A mail questionnaire on strategic planning yielded a total of 562 usable surveys (37.4% response rate). An unexpectedly small proportion (less than 31%) of respondents reported using strategic planning. Respondents who conducted strategic planning rated significantly higher the time available for their knowledge of, and the importance of strategic planning than those respondents who did not conducts strategic planning.

Impact of a clinical pharmacokinetic service on patients treated with aminoglycosides for gram-negative infections.

The present study was a retrospective, case-control design aimed at evaluating whether the clinical pharmacokinetic service (CPS) is cost-effective, as assessed by lengths of hospital stay and aminoglycoside therapy, incidence of a decrease in renal function, and time for resolution of infection as determined by vital signs. Forty-six patients were entered into this study, and were matched by defined criteria. The results of the study demonstrated a six-day difference in hospital stay for the CPS group (p less than 0.05). Length of aminoglycoside therapy was 33 hours shorter for the CPS group. Additionally, the time necessary for resolution of the infection was significantly shorter for this group, as assessed by vital signs returning to normal or baseline. Three patients in each group expired. Two patients in the CPS group and five in the control group developed aminoglycoside-associated increases in serum creatinine. No significant difference was found between the two groups in age, weight, or APACHE II score. Additionally, the two groups were similar with respect to concomitant diseases and concomitant antibiotics used. The approximate cost of the CPS was calculated as $56 per patient. Use of the CPS decreasing hospital stay by six days (mean $1875/patient) would translate to an annual savings of $654,375 in hospital charges, assuming 365 patients received aminoglycoside therapy per year.

Comparative bioequivalence and efficacy of two sustained-release procainamide formulations in patients with cardiac arrhythmias.

This investigation evaluated the bioequivalence and efficacy of two sustained-release procainamide products. Ten patients with cardiac arrhythmias were randomized to product A (Procan-SR) or product B (Pronestyl-SR). After nine doses of study medication, plasma procainamide and N-acetylprocainamide concentrations were obtained to determine the area under the concentration versus time curve at steady state (AUCSS), mean plasma concentration (CSSav), the observed peak plasma concentration (CSSmax), the observed trough plasma concentration (CSSmin), and the apparent time to achieve CSSmax (tmax). The products were compared on a milligram-equivalent (adjusted) basis. Following completion of blood sampling, patients were crossed-over to the alternate product. There was no washout between treatments. After nine doses of the alternate test medications, blood sampling was repeated. Differences in AUCSS, CSSav, CSSmax, tmax, and intradose peak/trough ratios were not statistically significant. Within-group variability in AUCSS, CSSav CSSmax, and tmax was greater with product B, but this trend did not reach statistical significance. Antiarrhythmic efficacy was not significantly different between the two treatments. Although the greater bioequivalence, lesser variability, and the greater number of tablet dosage sizes would favor product A, patients stabilized on a particular brand of sustained-release procainamide should not be switched to another product without careful monitoring. One patient in this study developed nonsustained ventricular tachycardia with low procainamide plasma concentrations after being switched from product A to product B.