Bridging clinical practice and systematic evidence
The Concurrent Biologics Registry is an open-access quality assurance and practice improvement resource dedicated to documenting the outcomes and safety of concurrent biologic therapy across immune-mediated inflammatory diseases. By aggregating real-world evidence from published literature and de-identified clinical submissions worldwide, the registry addresses a critical gap in the current evidence base.
Background
Biologic Therapies in Immune-Mediated Disease
In clinical practice, a growing number of patients require more than one biologic agent, yet the evidence base for concurrent use remains far behind the clinical need.
Biologic medications represent one of the most significant therapeutic advances in the management of immune-mediated inflammatory diseases. These agents are engineered to target specific molecular pathways involved in disease pathogenesis, offering a precision approach distinct from conventional systemic therapies that exert broad immunosuppressive effects.
Multiple biologic classes are now in clinical use across rheumatology, gastroenterology, dermatology, and related specialties, including TNF-alpha inhibitors, IL-17 and IL-23 inhibitors, IL-4/IL-13 pathway blockers, anti-IgE agents, B-cell depleting therapies, and IL-12/23 inhibitors, each targeting distinct immunologic mechanisms across a growing range of indications.
The prevailing prescribing paradigm, however, remains monotherapy: one biologic agent for one target condition. This reflects the design of pivotal clinical trials, which typically evaluate a single agent against placebo or active comparator in a defined patient population. In clinical practice, a growing number of patients present with overlapping immune-mediated conditions or disease refractory to single-agent therapy, creating scenarios where concurrent biologic use becomes a clinical consideration.
The Evidence Gap
Why systematic data remains scarce
Outside of a small number of emerging studies, primarily in gastroenterology, the prospective data on concurrent biologic therapy remain limited. The evidence that does exist is scattered across isolated case reports, small case series, and retrospective analyses throughout the medical literature.
In clinical practice, a growing number of patients present with overlapping immune-mediated conditions or with disease refractory to single-agent therapy, creating scenarios where concurrent biologic use becomes a clinical consideration. These situations span gastroenterology, rheumatology, dermatology, and other disciplines, yet the evidence base has not kept pace with the clinical need.
While a small number of prospective studies have begun to explore dual biologic approaches, the vast majority of available evidence remains confined to isolated case reports, small case series, and retrospective analyses scattered throughout the medical literature. No centralized resource has existed to aggregate these findings in a systematic, searchable format.
Despite this, physicians increasingly find themselves prescribing biologic combinations, often observing favorable clinical outcomes. The disconnect between clinical reality and available evidence leaves clinicians relying on individual experience and mechanistic extrapolation rather than systematic, aggregated data.
Purpose and Design
A Dual-Source Evidence Model
The registry was created to bridge the gap between clinical practice and real-world evidence through two complementary data pathways.
Published Literature
Cases documented in peer-reviewed journals, including case reports, case series, and observational studies describing patients treated with two or more biologics simultaneously, are identified, extracted, and catalogued in a standardized format.
Clinical Submissions
Healthcare professionals submit de-identified case data following a structured template capturing only aggregate clinical variables. Each submission undergoes quality review for completeness, clinical plausibility, and consistency before inclusion in the registry.
This dual-source model enables the registry to capture both the published evidence base and the substantial volume of unpublished clinical experience that would otherwise remain inaccessible. The real-world evidence generated complements data from randomized controlled trials by reflecting the complexity, heterogeneity, and comorbidity burden encountered in actual patient populations.
Clinical scope
What the Registry Captures
The registry encompasses a broad range of immune-mediated inflammatory diseases and records a comprehensive set of clinical and demographic variables for each case. Data sourced from published literature and de-identified clinical submissions worldwide reflects an international collaborative effort.
De-identified demographics
Age bracket and sex
Biologic Agents
Specific agents prescribed, designated as Biologic A and Biologic B
Primary Diagnosis
Disease category and relevant comorbid conditions
Duration of Therapy
Length of concurrent biologic treatment
Concomitant Medications
Any systemic medications administered alongside biologics
Clinical Outcome
Categorized on a standardized scale from complete remission to no response
Adverse Events
Any adverse events observed during the treatment period
Innovation and Significance
Why This Registry Matters
To date, no other centralized registry has been dedicated specifically to documenting the outcomes and safety of concurrent biologic therapy combinations.
Pattern Recognition
By consolidating cases that would otherwise remain isolated in individual publications or unreported in clinical practice, the registry enables pattern recognition across a growing body of evidence. Clinicians can identify which biologic combinations have been used, in what clinical contexts, and with what outcomes.
Safety Signal Detection
Systematic capture of adverse event data across biologic pairs provides an early detection mechanism for safety concerns that may not be apparent from monotherapy data alone, particularly for combinations that have not been studied in formal clinical trials.
Toward Consensus
As the evidence base grows, aggregated data from the registry can inform the development of consensus recommendations and best-practice guidance for concurrent biologic prescribing across specialties.
Open-Access Collaboration
The open-access, collaborative model promotes transparency and knowledge sharing across institutions and geographic boundaries. By lowering the barrier to contributing and accessing clinical evidence, the registry accelerates the translation of real-world experience into actionable clinical knowledge.
Leadership
Led by CMSD
The Concurrent Biologics Registry is led by Dr. Maksym Breslavets, MD, PhD, FRCPC, FAAD, and managed through the Centre for Medical and Surgical Dermatology (CMSD). The registry serves as a quality assurance tool for clinical practice, supporting informed decision-making when concurrent biologic therapy is considered.
Contributors
Project Contributors
The Concurrent Biologics Registry is built through clinical leadership, systematic literature review, and platform development.
Principal Investigator and Registry Director
Conceptualization, project administration, clinical oversight, and registry governance. Scientific direction of the registry, clinical review of submitted cases, and ongoing stewardship of the project's objectives are led by Dr. Breslavets as the originating investigator.
Chelsea Butler, BSc
Clinical Research Contributor
Systematic literature review and data acquisition. Structured searches of published concurrent dual biologic cases and ongoing curation of the registry's foundational dataset across treatment, outcome, and demographic variables are conducted by Chelsea Butler, a medical student at the University of Ottawa Faculty of Medicine.
Technical Lead and Platform Developer
Software engineering, platform architecture, and data visualization. Design and maintenance of the registry's technical platform, ongoing development of the case submission and review workflows, and refinement of the interactive visualizations that make the aggregated dataset accessible to clinicians are led by Denys Breslavets.
Behind the Registry
Operated by CMSD, Built by Dermi
The Centre for Medical and Surgical Dermatology (CMSD) operates the registry; the technical platform was built and is maintained by Dermi, a Toronto-based healthcare technology company.
Dermi specializes in local-first clinical software built around privacy by design, where protections are enforced through architecture rather than policy alone. While the registry is centrally hosted, it applies the related principle of data minimization, collecting only what is strictly necessary.
Outside of the registry, CMSD partners with Dermi to provide open-access clinical resources, such as dermatology calculators, including PASI, EASI, VASI, IHS4, and others, freely available at cmsderm.ca/calculators.
Funding and compensation
The Concurrent Biologics Registry is provided free of charge. Neither CMSD nor Dermi receives compensation for this work, and the registry receives no pharmaceutical industry funding. Pharmaceutical companies and drug manufacturers play no role in the registry's scope, methodology, or content.
Privacy
Patient Privacy as a Foundational Principle
The registry is designed so that personally identifiable health information is never collected. The submission template captures only aggregate clinical variables - age bracket, sex, disease category, biologic agents, duration, outcomes, and adverse events. No dates of birth, treatment dates, or geographic identifiers that could enable patient re-identification are requested at any stage.
For complete details on data handling practices, refer to the Privacy Policy.