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4. Impact of psoriasis disease severity and special area involvement on patient-reported outcomes in the real world: an analysis from the CorEvitas psoriasis registry.

Author

Strober, Bruce, Duffin, Kristina Callis, Lebwohl, Mark, Sima, Adam, Janak, Jud, Patel, Manish, Photowala, Huzefa, Garg, Vishvas, and Bagel, Jerry

Subjects
PATIENT reported outcome measures, PSORIASIS, PHYSICAL mobility, QUALITY of life
Abstract

Background: The impact of psoriasis in special areas (i.e., scalp, nails, palms, soles, genitals) on patient physical functioning, health-related quality of life (HRQoL), and work abilities has not been fully characterized. We assessed associations between disease severity and special area involvement in psoriasis symptoms, HRQoL, and work/activity impairment. Methods: Patients with psoriasis from the CorEvitas Psoriasis Registry who initiated systemic treatment between 04/2015–06/2020 were included. Outcomes were change from baseline in psoriasis symptoms, Dermatology Life Quality Index (DLQI), and work/activity impairment at 6months stratified by baseline disease severity and special area involvement. Results: Among 2620 patients, increasing disease severity was associated with worsening patient-reported outcomes. Patients with (46.0%; N=1205) versus without (54.0%; N=1415) psoriasis in special areas reported greater HRQoL and work/activity impairment. Over 6months, patients with unchanged or worsening disease severity had reduced HRQoL and increased symptom severity; incremental increases in patient HRQoL and decreases in symptom severity were associated with improved disease severity. Conclusions: Higher disease severity and special area involvement was associated with worse outcomes and impaired work abilities. These data highlight the significant impact that adequate treatment of severe psoriasis and/or special area involvement may have on patient HRQoL and function. [ABSTRACT FROM AUTHOR]

Published
2024
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28. Bisphosphonates and Nonhealing Femoral Fractures: Analysis of the FDA Adverse Event Reporting System (FAERS) and International Safety Efforts: A Systematic Review from the Research on Adverse Drug Events And Reports (RADAR) Project

Author

Edwards, Beatrice J, Bunta, Andrew D, Lane, Joseph, Odvina, Clarita, Rao, D Sudhaker, Raisch, Dennis W, McKoy, June M, Omar, Imran, Belknap, Steven M, Garg, Vishvas, Hahr, Allison J, Samaras, Athena T, Fisher, Matthew J, West, Dennis P, Langman, Craig B, and Stern, Paula H

Published
2013
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34. Clinical and economic analysis of outcomes of dose tapering or withdrawal of tumor necrosis factor-α inhibitors upon achieving stable disease activity in rheumatoid arthritis patients

Author

Aletaha,Daniel, Snedecor,Sonya, Ektare,Varun, Xue,Mei, Bao,Yanjun, Garg,Vishvas, Aletaha,Daniel, Snedecor,Sonya, Ektare,Varun, Xue,Mei, Bao,Yanjun, and Garg,Vishvas

Abstract

Daniel Aletaha,1 Sonya J Snedecor,2 Varun Ektare,2 Mei Xue,2 Yanjun Bao,3 Vishvas Garg3 1Division of Rheumatology, Department of Internal Medicine, Medical University of Vienna, Vienna, Austria; 2Pharmerit International, Bethesda, MD, 3AbbVie Inc., North Chicago, IL, USA Objective: To compare the real-world, 5-year clinical and cost impact of maintaining treatment with the tumor necrosis factor-α inhibitors (anti-TNFs) adalimumab, etanercept, or infliximab vs dose tapering or withdrawal in rheumatoid arthritis (RA) patients who have achieved remission (defined as a 28-joint count Disease Activity Score [DAS28] < 2.6) or low disease activity (LDA; DAS28 < 3.2). Methods: Using a 5-year Markov model with 1-month cycle length, we examined the clinical and cost impact of three treatment strategies: withdrawal, tapering, or maintenance of anti-TNFs among RA patients in remission or who have achieved LDA. This model assessed the time to loss of disease control, time to regaining control after treatment reinitiation, and associated medical and anti-TNF costs. To determine the risk of losing disease control, 14 studies (2309 patients) were meta-analyzed, adjusted for treatment strategy, anti-TNF, RA patient type (early or established RA), and model entry criterion (remission or LDA). Results: Anti-TNF withdrawal and tapering incurred comparable 5-year total costs (€37,900–€59,700 vs €47,500–€59,200), which were lower than those incurred by anti-TNF maintenance (€67,100–€72,100). Established RA patients had higher total costs than early RA patients (€45,900–€72,100 vs €37,900–€71,700). Maintenance was associated with the longest time to loss of disease control (range, 27.3–47.1 months), while withdrawal had the shortest (range, 6.9–30.5 months).Conclusion: Dose tapering or withdrawal of anti-TNF

Published
2017

37. Impact of Participation in the Adalimumab (Humira) Patient Support Program on Rheumatoid Arthritis Treatment Course: Results from the PASSION Study.

Author

den Bosch, Filip, Ostor, Andrew, Wassenberg, Siegfried, Chen, Naijun, Wang, Chen, Garg, Vishvas, and Kalabic, Jasmina

Subjects
ADALIMUMAB, RHEUMATOID arthritis treatment, DRUG marketing, HEALTH programs, QUESTIONNAIRES, THERAPEUTICS
Abstract

Introduction: Patients with rheumatoid arthritis (RA) who are treated with adalimumab (ADA) are offered a proprietary patient support program (PSP, AbbVie Care). The main objective of this study was to examine the effectiveness of ADA on RA treatment course over time in the context of PSP utilization. Methods: PASSION was a 78-week post-marketing observational study of RA patients with an insufficient response to ≥1 DMARD newly initiating ADA in routine clinical care that was conducted in Europe, Israel, Mexico, Puerto Rico, and Australia. One prior biologic DMARD was allowed. The primary endpoint was percentage of patients achieving the minimal clinically important difference (MCID; improvement of ≥0.22 compared to baseline) in Health Assessment Questionnaire (HAQ) Disability Index (HAQ-DI) at week 78. Additionally, multiple clinical and patient-reported outcomes (PROs) were evaluated over time. Patients were categorized based on their participation in the PSP: ever (PSP users) vs. never (PSP non-users). Safety events were monitored throughout the study. Results: Overall, 42.8% of PSP users achieved the MCID in HAQ-DI at week 78 (improvement of at least 0.22 compared to baseline). From 1025 enrolled, 48.7% of patients were PSP users while treated with ADA. The percentage of patients achieving MCID in the HAQ-DI was higher in PSP users vs. PSP non-users (48.1 vs. 37.8%) at week 78 ( p < 0.001, NRI). Most of the studied clinical outcomes and PROs showed significant improvements ( p < 0.05) from baseline to week 78 favoring PSP users over PSP non-users. Conclusions: In patients with moderate-to-severe RA who initiated ADA, improvements in clinical, functional, and PROs were achieved in real-world settings with significantly greater improvements among PSP users in comparison with PSP non-users. Funding: AbbVie. Trial registration: ClinicalTrials.gov identifier, NCT01383421. [ABSTRACT FROM AUTHOR]

Published
2017
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38. Life-threatening dermatologic adverse events in oncology

Author

Rosen, Alyx C., primary, Balagula, Yevgeniy, additional, Raisch, Dennis W., additional, Garg, Vishvas, additional, Nardone, Beatrice, additional, Larsen, Nicole, additional, Sorrell, Jennifer, additional, West, Dennis P., additional, Anadkat, Milan J., additional, and Lacouture, Mario E., additional

Published
2014
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39. Levamisole contamination of cocaine resulting in neutropenia and thrombovasculopathy: a report from the Southern Network on Adverse Reactions (SONAR)

Author

Magwood, Jametta, primary, Murday, Alanna, additional, Zhu, Nancy, additional, Georgantopoulos, Peter, additional, Qureshi, Zaina, additional, Buchanan, Jennie, additional, Baumbach, Joan, additional, Dy, Irene, additional, Norris, LeAnn, additional, Dart, Richard, additional, Gilbert, Erin, additional, Mahindra, Priya, additional, Kehr, Heather, additional, Rossi, Anthony, additional, Singh, Sarveshwari, additional, Edlin, Brian, additional, Gonsky, Jason, additional, Ray, Paul, additional, Michels, Jill, additional, Richardson, William, additional, Garg, Vishvas, additional, Shen, Xian, additional, Raisch, Dennis, additional, McKoy, June, additional, Rao, Gowtham, additional, Sartor, Oliver, additional, Ablin, Richard, additional, Bennett, Charles, additional, and Wiernik, Peter, additional

Published
2013
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41. Impact of United States Food and Drug Administration's boxed warnings on adverse drug reactions reporting rates and risk mitigation for multiple myeloma drugs

Author

Garg, Vishvas, primary, Raisch, Dennis W, additional, McKoy, June M, additional, Trifilio, Steven M, additional, Holbrook, Jamiee, additional, Edwards, Beatrice J, additional, Belknap, Steven M, additional, Samaras, Athena T, additional, Nardone, Beatrice, additional, and West, Dennis P, additional

Published
2013
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42. Association of breast cancer in men with exposure to 5-α reductase inhibitors: A RADAR report.

Author

Belknap, Steven M, primary, Godinez-Puig, Victoria, additional, Brannigan, Robert E, additional, Lin, Simon M, additional, Cashy, John, additional, Chowdhary, Rajesh, additional, Postelnick, Michael J, additional, Fotis, Michael A, additional, Irwig, Michael, additional, Khan, Seema Ahsan, additional, Gradishar, William John, additional, Garg, Vishvas, additional, Shen, Xian, additional, Raisch, Dennis W, additional, Nardone, Beatrice, additional, Rosen, Steven T., additional, Edwards, Beatrice J., additional, McKoy, June M, additional, Yarnold, Paul R, additional, and West, Dennis P., additional

Published
2012
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43. Bisphosphonates and esophageal cancer: A RADAR report.

Author

Edwards, Beatrice J., primary, Nardone, Beatrice, additional, Raisch, Dennis W, additional, Mckoy, June M., additional, Belknap, Steven M, additional, Holbrook, Jaimee S, additional, Garg, Vishvas, additional, Shen, Xian, additional, Godinez-Puig, Victoria, additional, Trifilio, Steven M, additional, Emmanuel, Romala, additional, West, Dennis P., additional, and Rosen, Steven T., additional

Published
2012
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48. Anaphylaxis associated with gadolinium-based contrast agents: data from the Food and Drug Administration's adverse event reporting system and review of case reports in the literature

Author

Raisch, Dennis W, Garg, Vishvas, Arabyat, Rasha, Shen, Xian, Edwards, Beatrice J, Miller, Frank H, McKoy, June M, Nardone, Beatrice, and West, Dennis P

Abstract

Objectives:To summarize reports of anaphylaxis associated with gadolinium-based contrast agents (GBCAs) reported to the Food and Drug Administrations Adverse Event Reporting System (FAERS), examine the safety signals of anaphylaxis from GBCAs, and perform a literature review of relevant case reports.Methods:FAERS (1/1988-8/2012) was searched using groups of preferred event terms for anaphylaxis combined with all drug names for GBCAs Signal detection involved determination of proportional reporting ratios (PRRs) and empirical Bayes geometric means (EBGM). Published case reports were identified through a Medline search (1/1988-7/2013).Results:There were 614 GBCA FAERS reports of anaphylaxis, resulting in a safety signal (PRR 6.2, 95% confidence interval (CI) 5.7 – 6.7; EBGM 5.1 CI 5.6 – 6.6). Among GBCAs, 43% were associated with gadopentetate dimeglumine (PRR 4.9, CI 4.3 – 5.5; EBGM 4.8, CI 4.3 – 5.4), 29% with gadobenate dimeglumine (PRR 17.5, CI 15.2 – 20.2; EBGM 17.1, CI 14.6 – 19.8) , and 17% with gadoteridol (PRR 5.7, CI 4.7 – 6.8; EBGM 5.6, CI 4.6 – 56.7). There were 14 anaphylaxis case reports in the literature.Conclusions:GBCAs used as medical imaging agents, can cause life-threatening or fatal anaphylaxis. There were differences in disproportionality of reporting between between agents. Although differences in numbers of reports of anaphylaxis reflect relative utilization rates of the various agents, disproportionality analyses (PRR, EBGM) disclose significant safety signals of anaphylaxis associated with most GBCAs.

Published
2014
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49. Use of Number Needed to Treat in Cost-Effectiveness Analyses

Author

Garg, Vishvas, Shen, Xian, Cheng, Yan, Nawarskas, James J, and Raisch, Dennis W

Abstract

OBJECTIVE To review the use of number needed to treat (NNT) and/or number needed to harm (NNH) values to determine their relevance in helping clinicians evaluate cost-effectiveness analyses (CEAs).DATA SOURCES PubMed and EconLit were searched from 1966 to September 2012.STUDY SELECTION AND DATA EXTRACTION Reviews, editorials, non–English-language articles, and articles that did not report NNT/NNH or cost-effectiveness ratios were excluded. CEA studies reporting cost per life-year gained, per quality-adjusted life-year (QALY), or other cost per effectiveness measure were included. Full texts of all included articles were reviewed for study information, including type of journal, impact factor of the journal, focus of study, data source, publication year, how NNT/NNH values were reported, and outcome measures.DATA SYNTHESIS A total of 188 studies were initially identified, with 69 meeting our inclusion criteria. Most were published in clinician-practice–focused journals (78.3%) while 5.8% were in policy-focused journals, and 15.9% in health-economics–focused journals. The majority (72.4%) of the articles were published in high-impact journals (impact factor >3.0). Many articles focused on either disease treatment (40.5%) or disease prevention (40.5%). Forty-eight percent reported NNT as a part of the CEA ratio per event. Most (53.6%) articles used data from literature reviews, while 24.6% used data from randomized clinical trials, and 20.3% used data from observational studies. In addition, 10% of the studies implemented modeling to perform CEA.CONCLUSIONS CEA studies sometimes include NNT ratios. Although it has several limitations, clinicians often use NNT for decision-making, so including NNT information alongside CEA findings may help clinicians better understand and apply CEA results. Further research is needed to assess how NNT/NNH might meaningfully be incorporated into CEA publications.

Published
2013
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