POS0271-HPR PATIENT PERSPECTIVE ON A DRUG SAFETY MONITORING SYSTEM FOR IMMUNE-MEDIATED INFLAMMATORY DISEASES BASED ON PATIENT-REPORTED OUTCOMES
Authors: L. Kosse, G. Weits, H. Vonkeman, S. Tas, F. Hoentjen, M. Van Doorn, P. Spuls, G. D’haens, M. Nurmohamed, E. Van Puijenbroek, B. Van den Bemt, N. Jessurun
Journal: Annals of the Rheumatic Diseases (2021)

Background: Patient-reported outcomes (PROs) on adverse drug reactions (ADRs) are increasingly used in cohort event monitoring (CEM) to obtain a better understanding of patient’s real-world experience with drugs. Despite the leading role for patients, little is known about their perspectives on these monitoring systems. Objectives: To obtain more insight in patients’ perspectives on the perceived usefulness, ease of use and attitude toward using the Dutch Biologic Monitor (DBM), and their preferred design for a national drug safety monitoring system for immune-mediated inflammatory diseases (IMIDs). Methods: We developed a cross-sectional open survey following the rationale of the Technology Acceptance Model to obtain insight in patients’ perspectives on the DBM. The DBM is a pilot for a PRO-based drug safety monitoring system focused on ADRs attributed to biologics that are prescribed for IMIDs. This survey consisted of 20 categorical and 1 open-ended question. Seven categorical questions contained a text field for additional comments. Five-point Likert-type scales or multiple-choice questions were used to identify patients’ preferences and perspectives. Patients were eligible for the survey if they were still enrolled in the DBM at the time of the survey opening and if they had completed at least one questionnaire of the DBM. Categorical questions were descriptively analyzed, whereas text fields were analyzed using theoretical thematic analysis. Results: At the start of the survey a total of 1,225 patients had participated in the DBM. Approximately 70% had an inflammatory rheumatic disease. The survey was completed by 292 eligible respondents (response rate 44.8%). The respondents generally agreed that it was useful to participate in the DBM and would recommend it to their peers (Figure 1). The response burden of the bimonthly questionnaires was scored as ‘low’, irrespective of the presence of ADRs or education level (Table 1). A number of respondents suggested that the questionnaire frequency should be synchronized with the regular hospital visits or the administration schedule of the biologic. Moreover, questionnaires should be offered less frequent and preferably shortened in case of an unaltered situation or absence of ADRs. Half (49.0%) of the respondents was interested in sharing their questionnaires with a medical specialist, whereas a third (34.2%) advocated sharing the questionnaires with their pharmacist (Figure 1). Table 1. Perceived response burden of the Dutch Biologic Monitor questionnaires. The average burden is calculated using a five-point Likert-type scale. Data is represented as the number of respondents (n). Overall (n = 292 ) ADRs reported Education level a Yes (n = 225 ) No (n = 54 ) Do not know (n = 13 ) Lower (n = 149 ) Higher (n = 139 ) Burden n (% ) n (% ) n (% ) n (% ) n (% ) n (% ) 1: No burden 224 (76.7) 169 (75.1) 46 (85.2) 9 (69.2) 106 (71.1) 115 (82.7) 2: Low burden 58 (19.9) 48 (21.3) 7 (13.0) 3 (23.1) 36 (24.2) 22 (15.8) 3: Moderate burden 6 (2.1) 6 (2.7) 0 (0.0) 0 (0.0) 4 (2.7) 2 (1.4) 4: High burden 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 5: Very high burden 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) No opinion 4 (1.4) 2 (0.9) 1 (1.9) 1 (0.0) 3 (2.0) 0 (0.0) Average burden 1.2 1.3 1.1 1.2 1.3 1.2 a Missing: 4 respondents. Figure 1. Stacked bar graph of user perspectives. Agreement scores were measured using a five-point Likert-type scale. The average agreement score per statement is indicated on the far right. The percentages represent the share of respondents. DBM: Dutch Biologic Monitor; ADRs: adverse drug reactions. Conclusion: This study provides valuable insights in the patient perspective on a PRO-based drug safety monitoring system for inflammatory rheumatic diseases and other IMIDs, and provides several useful starting points to further stimulate and improve PRO-based CEM systems. Altogether, it appears feasible to establish a PRO-based drug safety monitoring system that monitors IMID patients’ real-world experience with ADRs that has a low burden for the participants. Disclosure of Interests: Leanne Kosse: None declared, Gerda Weits: None declared, Harald Vonkeman Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Celgene, Celltrion, Galapagos, Gilead, GSK, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi-Genzyme, all outside the submitted work., Sander Tas Grant/research support from: AbbVie, Arthrogen, AstraZeneca, BMS, Celgene, Galapagos, GSK, MSD, Pfizer, Roche, Sanofi-Genzyme, all outside the submitted work., Frank Hoentjen Speakers bureau: Abbvie, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz and Dr Falk, all outside the submitted work, Consultant of: Celgene, Janssen-Cilag, all outside the submitted work, Grant/research support from: Dr Falk, Janssen-Cilag, Abbvie, Takeda, all outside the submitted work, Martijn van Doorn Grant/research support from: Leopharma, Novartis, Abbvie, BMS, Celgene, Lilly, MSD, Pfizer, Sanofi-Genzyme, Janssen Cilag, outside the submitted work., Phyllis Spuls Grant/research support from: Departmental independent research grant for TREAT NL registry from different companies, is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital and, is Chief Investigator (CI) of the systemic and phototherapy atopic eczema registry (TREAT NL) for adults and children and one of the main investigators of the SECURE-AD registry, all outside the submitted work., Geert D’Haens Consultant of: Abbvie, Ablynx, Active Biotech AB, Agomab Therapeutics, Allergan, Alphabiomics, Amakem, Amgen, AM Pharma, Applied Molecular Therapeutics, Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol Meiers Squibb/Celgene, Boehringer Ingelheim, Celltrion, Cosmo, DSM Pharma, Echo Pharmaceuticals, Eli Lilly, Engene, Exeliom Biosciences, Ferring, DrFALK Pharma, Galapagos, Genentech/Roche, Gilead, Glaxo Smith Kline, Gossamerbio, Pfizer, Immunic, Johnson and Johnson, Kintai Therapeutics, Lycera, Medimetrics, Takeda, Medtronic, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Nextbiotics, Novonordisk, Otsuka, Photopill, ProciseDx, Prodigest, Prometheus laboratories/Nestle, Progenity, Protagonist, RedHill, Robarts Clinical Trials, Salix, Samsung Bioepis, Sandoz, Seres/Nestec/Nestle, Setpoint, Shire, Teva, Tigenix, Tillotts, Topivert, Versant and Vifor, all outside the submitted work, Michael Nurmohamed Speakers bureau: AbbVie, Celgene, Celltrion, Eli Lilly, Janssen, Sanofi, all outside the submitted work, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, Roche, Sanofi, all outside the submitted work, Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Mundipharma, Novartis, Pfizer, Roche, Sanofi, all outside the submitted work, Eugène van Puijenbroek: None declared, Bart van den Bemt: None declared, Naomi Jessurun: None declared