Evaluation of the Effectiveness of Additional Risk Minimisation Measures for Tofacitinib (Xeljanz^®) in Europe: A Prescriber Survey.

IF 2.9 3区医学 Q2 PHARMACOLOGY & PHARMACY Clinical Drug Investigation Pub Date : 2024-11-28 DOI:10.1007/s40261-024-01408-5

Joanne Wu, Nana Koram, Kofi Asomaning, Lubna Merchant, Robert Massouh, Edward Nagy, Subhan Khalid, Laura Walsh, Rafia Bosan, Krystal Cantos

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引用次数: 0

Abstract

Objective: We evaluated the effectiveness of tofacitinib (oral Janus kinase inhibitor) additional risk minimisation measures (aRMM) in Europe via prescriber surveys. Operational challenges/methodological limitations of surveys and recommendations for future considerations were summarised.

Methods: In this post-authorisation safety study, multimodal surveys were conducted in eight European countries from 2021 to 2022 among prescribers of tofacitinib for rheumatoid arthritis and/or psoriatic arthritis (RA/PsA) or ulcerative colitis (UC) in the 12 months preceding survey administration. Prescribers' awareness (receipt) of aRMM materials, knowledge of key risk messages and adherence to risk minimisation practices were assessed. A priori effectiveness thresholds (≥ ~80%) were set across outcomes.

Results: Of 18,764 and 12,777 prescribers invited to take the RA/PsA or UC survey, 164 and 81 completed the surveys, respectively (response proportion: 326/18,764, 1.7%; 154/12,777, 1.2%, respectively). Among completers, self-reported receipt of all initial and/or 2019 updated aRMM materials was 33.5% and 32.7% in the RA/PsA and UC surveys, respectively. In the RA/PsA and UC surveys, 39.5% and 24.5%, respectively, answered ≥ ~80% of knowledge questions correctly; 51.2% and 69.7%, respectively, provided desirable responses to ≥ ~80% of adherence questions.

Conclusions: Although the tofacitinib aRMM materials did not achieve the desired effectiveness for awareness (receipt), knowledge or adherence to risk minimisation practices among survey completers, the study was deemed inconclusive given the low response rate. This demonstrated that unless an acceptable response rate is achieved, surveys should not be the only method for aRMM evaluation. Secondary data may supplement future surveys to increase their robustness.

Hma-ema catalogues registration: EUPAS43143 (date of registration: 29/09/2021).

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来源期刊

Clinical Drug Investigation 医学-药学

CiteScore

5.90

自引率

3.10%

发文量

108

审稿时长

6-12 weeks

期刊介绍： Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.