The British Association of Dermatologists’ Biologic Interventions Register (BADBIR): design, methodology and objectives

Abstract

Summary Background The British Association of Dermatologists (BAD) established a web‐based pharmacovigilance register to assess the long‐term safety of biologics prescribed for patients with severe psoriasis in September 2007. The BAD Biologic Interventions Register (BADBIR) also participates in the network of European psoriasis biologics registers (Psonet). Objectives This prospective observational cohort study compares adult patients with psoriasis treated with biologics vs. a comparator group exposed to conventional systemic therapies. Methods Following baseline data acquisition, clinicians record changes in therapy, disease activity and adverse events for 5 years (6‐monthly for 3 years, then annually thereafter). Patient details are flagged lifelong on the National Health Service Information Centre system to capture occurrence of malignancy or death. Primary study endpoints include malignancy, infection, serious adverse events and death. Collection of long‐term effectiveness data is a subsidiary aim. Results By November 2011, the number of dermatology centres actively recruiting across the U.K. and Republic of Ireland had risen to 108 and a further 37 were actively engaged in the set‐up process. Of the 3176 patients enrolled in the study to date, 2193 were registered within the biologic cohort and 983 in the conventional systemic (nonbiologic‐exposed) cohort. Conclusions A robust, high‐quality, web‐based register of biologic and conventional therapy for psoriasis has been established in the U.K. This is the largest project undertaken by the BAD. The data it will provide over the coming years will be invaluable to the safe use of biologics in clinical practice. A U.K.‐wide dermatology clinical research network has been established that provides a framework for future studies in other diseases.

Efficacy and Safety of Emerging Immunotherapies in Psoriasis

“…Ongoing vigilance to potential issues, in particular the risk of invasive candidiasis and exacerbation of inflammatory bowel disease in IL-17 inhibitors and the risk of MACE in IL-23 inhibitors, is important. The impact of these safety questions may only be adequately answered in the coming years with longer follow-up times and large-scale safety registries [62].…”

Differential Drug Survival of Biologic Therapies for the Treatment of Psoriasis: A Prospective Observational Cohort Study from the British Association of Dermatologists Biologic Interventions Register (BADBIR)

“…BADBIR, established in September 2007, compares a cohort of psoriasis patients on biologics to a similar cohort on conventional systemic therapies. A detailed report of the design of BADBIR has been published previously (Burden et al, 2012). Of relevance to the current study, the National Institute for Health and Care Excellence (NICE), a national guidance body, guidelines for the specific biologics include the criteria of PASI ≥20 and DLQI > 18 for the prescription of infliximab, and PASI ≥ 10, DLQI > 10 for the other biologics.…”

“…Ireland (ROI) prospective, longitudinal pharmacovigilance register which represents an ideal resource to assess real-world drug survival with biologics for psoriasis due to: its size, which allows for analysis of both TNFIs and ustekinumab; a rigorous data collection process; independent data analysis; inclusion of important covariates and; high external validity through participation of multiple dermatology centres (Burden et al, 2012). The aims of the current study were to establish which biologic is most likely to persist in biologic naïve patients with psoriasis and to identify clinically relevant risk factors for drug discontinuation.…”

What Happened after the Clinical Trials: Long-Term Safety and Efficacy of Ustekinumab in Daily Clinical Practice

“…These trials led to the approval and post-trial use of ustekinumab as an available therapeutic option in daily clinical practice. However, there are few data from one center on patients treated continuously over 12 months outside randomized clinical trials [18,19] or long-term registries [20,21]. …”