Search

David Bergman,1 Bjorn Roelstraete,1 Jiangwei Sun,1 Fahim Ebrahimi,1,2 Rickard Lidström,3 Axel Svedbom,4,5 Mona Ståhle,4 Jonas F Ludvigsson1,6,7 1Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; 2Department of Gastroenterology and Hepatology, Clarunis University Center for Gastrointestinal and Liver Diseases, Basel, Switzerland; 3Diagnostiskt Centrum Hud, Stockholm, Sweden; 4Division of Dermatology and Venereology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden; 5Dermatology and Venereology Clinic, Karolinska University Hospital, Stockholm, Sweden; 6Department of Pediatrics, Orebro University Hospital, Orebro, Sweden; 7Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY, USACorrespondence: David Bergman, Email David.bergman.1@ki.seBackground: Microscopic colitis (MC) has been associated with several immune-mediated diseases including psoriasis, but earlier research has been limited to psoriasis occurring before MC. Data from large-scale cohort studies investigating MC and risk of future psoriasis are lacking.Objective: To examine the association between MC and psoriasis.Methods: In a nationwide, population-based, matched cohort study in Sweden from 2007 to 2021, we identified 8404 patients with biopsy-verified MC (diagnosed in 2007– 2017), 37,033 matched reference individuals, and 8381 siblings without MC. Information on MC was obtained through the ESPRESSO cohort (a Swedish histopathology database with nationwide coverage). Using Cox regression, we calculated hazard ratios (HRs) and 95% confidence intervals (CIs) for psoriasis up until 2021.Results: During a median follow-up of 9.2 years (interquartile range = 6.7– 11.7), 179 MC patients and 440 reference individuals were diagnosed with psoriasis (241.1 vs 131.8 events per 100,000 person-years), corresponding to one extra case of psoriasis in 91 patients with MC over 10 years. After adjustment for the matching variables (birth year, sex, county of residence, and calendar period) and level of education, we computed an adjusted hazard ratio (aHR) of 1.82 (95% CI = 1.53– 2.17). Stratified by sex, estimates were similar and when examining the aHR across different lengths of follow-up, we found significantly elevated estimates up to 10 years after MC diagnosis. Compared to MC-free siblings, the aHR was 1.85 (95% CI = 1.36– 2.51).Conclusion: Patients with MC are at an almost doubled risk of psoriasis compared to the general population. Clinicians need to consider psoriasis in MC patients with skin lesions.Keywords: microscopic colitis, psoriasis, epidemiology

Karin Luttropp, 1 Johan Dalén, 1 Axel Svedbom, 1 Mary Dozier, 2 Christopher M Black, 3 Amy Puenpatom 3 1ICON Clinical Research, Plc., Stockholm, Sweden; 2ICON Clinical Research, Plc., Boston, MA, USA; 3Center for Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, NJ, USACorrespondence: Amy PuenpatomCenter of Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, NJ Tel +1 267 305 0620Fax +1 215 850 4549Email puenpatom.amy@merck.comPurpose: To obtain an up-to-date overview of the measurement of patient experience of switching biologic treatment in patients with inflammatory arthritis (IA) or ulcerative colitis (UC). Secondary objectives included summarizing the types of patient-reported outcomes (PROs) used (if any), and related findings; and summarizing medical and non-medical reasons for treatment switch and/or discontinuation.Methods: A systematic literature review (SLR) was performed, searching Medline and Embase for relevant publications.Results: In total, 70 relevant publications were identified. While the majority of these reported reasons for switching and/or discontinuing treatment, only four provided information explicitly regarding patient-reported experience of switching biologic treatment. All four utilized ranking tools to assess patient experience of switching biologic treatment. The most common reason for switching and/or discontinuing treatment was loss of efficacy, while the least common reason was patient preference.Conclusion: Although the number of available treatments in IA and UC have increased, there is a sparsity of information regarding patient-reported experience of switching biologic treatment. Further research regarding patient preference and/or experience would benefit this therapeutic area and help guide treatment choices.Keywords: arthritis, colitis, ulcerative, biological products, patient reported outcome measures, treatment switch

Erin Johansson,1 Mercedes Nuñez,2 Axel Svedbom,1 Tatiana Dilla,2 Susanne Hartz3 1Access, Commercialisation & Communications, ICON plc, Stockholm, Sweden; 2Health Outcomes and Real World Evidence, Eli Lilly, Madrid, Spain; 3Global Patient Outcomes and Real World Evidence International, Eli Lilly, Surrey, UK Background: Currently, several biologic agents are available for the treatment of moderate-to-severe plaque psoriasis, including newer agents with similar mechanisms of action and efficacy; therefore, there is a need to evaluate their efficiency in terms of cost effectiveness. Objective: This study evaluates the cost effectiveness of recently approved interleukin (IL)-17A antagonists, ixekizumab and secukinumab, for the treatment of moderate-to-severe plaque psoriasis from the perspective of the Spanish National Health System (NHS). Materials and methods: A Markov model with a lifetime horizon was developed to compare the cost effectiveness of ixekizumab vs. secukinumab in a hypothetical cohort of patients with moderate-to-severe plaque psoriasis. The model used monthly cycles and included four health states: a 12-week induction period, treatment maintenance, best supportive care (BSC), and death. Patients meeting response criteria at the end of the induction period transitioned to maintenance therapy, whereas non-responders transitioned to BSC. It was assumed that, each year, 20% of patients receiving maintenance therapy would discontinue treatment. The model incorporated data from various sources, including published literature, a network meta-analysis, and expert opinion for some variables. Results: Ixekizumab was dominant over secukinumab in that it gained 0.037 more quality-adjusted life years (QALYs) and saved €1951 in total costs over the lifetime horizon. Probabilistic sensitivity analysis showed a 96.6% likelihood that ixekizumab would be cost effective at a threshold of €30,000 per QALY gained. Conclusion: For the treatment of moderate-to-severe plaque psoriasis in Spain, ixekizumab provided additional QALYs and potential savings for the Spanish NHS compared with secukinumab. Since the magnitude of the differences in costs and QALYs was modest, other factors such as patient preferences (eg, for number of injections) and long-term safety (eg, related to time on the market) may also be important for guiding clinical decisions. Keywords: pharmacoeconomics, cost-utility, biologics, IL-17A antagonists

Axel Svedbom,1 Chiara Storck,2 Sumesh Kachroo,3 Marinella Govoni,4 Ahmed Khalifa5 1Real World Strategy and Analytics, Mapi Group, Stockholm, Sweden; 2Real World Strategy and Analytics, Mapi Group, Munich, Germany; 3Center for Observational and Real-World Evidence (CORE), Merck & Co, Kenilworth, NJ, USA; 4MSD Italy, Rome, Italy; 5Medical Affairs Immunology, MSD Switzerland, Luzern, Switzerland Purpose: In immune-mediated rheumatic diseases (IMRDs), persistence to treatment may be used as a surrogate marker for long-term treatment success. In previous comparisons of persistence to tumor necrosis factor α inhibitors (TNFis), a paucity of data for subcutaneous (SC) golimumab was identified. The aim of this study was to conduct a systematic review of persistence to SC golimumab in clinical practice and contextualize these data with five-year persistence estimates from long-term open-label extension (OLE) trials of SC TNFis in IMRDs.Patients and methods: PubMed, Embase, MEDLINE, and conference proceedings from European League Against Rheumatism (EULAR), American College of Rheumatology (ACR), and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) were searched. All studies on patients treated with SC golimumab for IMRD were included if they reported data on the persistence to golimumab.Results: Of 376 available references identified through the searches, 12 studies with a total of 4,910 patients met the inclusion criteria. Furthermore, nine OLE trials were available. Among the included studies from clinical practice, at six months, one year, two years, and three years, the proportion of patients persistent to treatment ranged from 63% to 91%, 47% to 80%, 40% to 77%, and 32% to 67%, respectively. In the four studies that included comparisons to other biologics, golimumab was either statistically noninferior or statistically superior to other treatments, an observation that was supported by indirect comparisons of unadjusted point estimates of OLE trials.Conclusion: The data reviewed in this study indicate that golimumab may have higher persistence than other TNFis, a notion that is supported by indirect comparisons of persistence data from OLEs of randomized controlled trials (RCTs). Furthermore, the study suggests that persistence may be lower in biologic-experienced compared with biologic-naive patients and higher in axial spondyloarthritis compared with rheumatoid arthritis and psoriatic arthritis. Keywords: golimumab, Simponi, Treatment persistence, drug survival, retention rates, real-world evidence (RWE)

Axel Svedbom,1 Johan Dalén,1 Christopher M Black,2 Sumesh Kachroo2 1Mapi Group, Stockholm, Sweden; 2Merck & Co., Inc., Kenilworth, NJ, USA Objectives: The objectives of this study were to 1) describe and compare treatment persistence with first- and second-line subcutaneous tumor necrosis factor-alpha inhibitors (SC-TNFis) in patients with ankylosing spondylitis (AS), psoriatic arthritis (PsA), or rheumatoid arthritis (RA) (collectively immune-mediated rheumatic disease) in Sweden and 2) estimate and contrast health care costs in the two groups.Methods: Patients who initiated their first or second SC-TNFi between May 6 2010 and December 12 2012 were identified from the Prescribed Drug Register. Persistence was estimated using survival analysis. Costs comprised specialized outpatient care, inpatient care, and medication. The persistence analysis was stratified by immune-mediated rheumatic disease diagnosis.Results: A total of 4,903 patients treated with their first and 845 patients treated with their second SC-TNFi were identified. Baseline characteristics differed between the two groups. Therefore, propensity score matching analysis was implemented. Second-line patients were matched to first-line patients, and four cohort pairs (AS, PsA, RA, and all diagnoses combined) were generated. Patients treated with their first SC-TNFi had statistically significant higher persistence than patients treated with their second SC-TNFi in PsA (P=0.036), RA (P=0.048), and all diagnoses combined (P

Background: Patients treated with systemics for moderate‐to‐severe psoriasis have increased risk of cardiovascular disease (CVD). However, to the best of our knowledge, there are no data on the association between clinical disease activity and future cardiovascular events in this population. Such data could help identify patients at increased CVD risk and inform the potential for CVD prevention with effective psoriasis treatment. Objective: To estimate the association between the Psoriasis Area and Severity Index (PASI) and cardiovascular events defined as hospitalization for CVD and cardiovascular death. Methods: We linked prospectively collected data on PASI and CVD risk factors to population‐based administrative data on hospitalizations and causes of death. We estimated the association between PASI and cardiovascular events using Cox proportional hazard models with PASI and Framingham 10‐year cardiovascular risk as time‐varying covariates. Results: A total of 767 patients with 6264 PASI scores were included. After adjusting for 10‐year cardiovascular risk and prior CVD, a one‐point increase in PASI was associated with a hazard ratio of 1.04 (95% CI: 1.01–1.07) for cardiovascular events. The findings were robust in sensitivity analyses. Conclusion: PASI is an independent marker for future cardiovascular events in patients with moderate‐to‐severe psoriasis. [ABSTRACT FROM AUTHOR]