Bridging clinical practice and systematic evidence
An open-access quality assurance and practice improvement resource documenting the outcomes and safety of concurrent biologic therapy across immune-mediated inflammatory diseases.
Registry model
Open access
The registry bridges clinical practice, where cases are managed one at a time, and systematic evidence, where outcomes are read across the whole record.
Documented one case at a time, read as one record.
Literature and clinician submissions, reviewed before inclusion.
Open access
No registration, login, or payment required
Two evidence sources
Published literature and clinician submissions worldwide
De-identified by design
No personally identifiable health information is collected
Background
Biologic Therapies in Immune-Mediated Disease
Biologic medications are among the most significant therapeutic advances in immune-mediated inflammatory disease. The paradigm for prescribing them, however, was set by trials of one agent at a time.
In clinical use across
- Rheumatology
- Gastroenterology
- Dermatology
- Related specialties
A precision approach
Mechanism of action
Conventional therapy
Broad immunosuppression
Effects are exerted across the immune system rather than on a single pathway.
Biologic therapy
One molecular target
Each agent is engineered against a specific pathway involved in disease pathogenesis.
Biologic classes in clinical use
- TNF-alpha inhibitors
- IL-17 inhibitors
- IL-23 inhibitors
- IL-12/23 inhibitors
- IL-4/IL-13 pathway blockers
- Anti-IgE agents
- B-cell depleting therapies
Each class targets a distinct immunologic mechanism across a growing range of indications.
The prevailing paradigm
One agent, one condition
- 01
Trials evaluate one agent
Pivotal studies test a single biologic against placebo or an active comparator in a defined patient population.
- 02
Prescribing follows the trials
The prevailing paradigm remains monotherapy: one biologic agent for one target condition.
- 03Today
Practice moves beyond them
Overlapping immune-mediated conditions and disease refractory to a single agent make concurrent use a clinical consideration.
The Evidence Gap
Why systematic data remains scarce
Concurrent biologic use is a consideration across gastroenterology, rheumatology, dermatology, and other disciplines, yet the evidence base has not kept pace with the clinical need.
Outside of a small number of emerging studies, the prospective data on concurrent biologic therapy remain limited.
The evidence base today
By study design
- Emerging
Prospective studies
A small number of emerging studies, primarily in gastroenterology, have begun to explore dual biologic approaches.
- Scattered
Case reports and retrospective analyses
The vast majority of available evidence: isolated reports, small case series, and retrospective analyses scattered across journals and specialties.
- Absent
Systematic aggregation
No centralized resource has existed to gather these findings in a systematic, searchable format.
Decisions today rest on
- Individual experience
- Mechanistic extrapolation
- Isolated reports
Physicians increasingly prescribe biologic combinations, often observing favorable outcomes, without systematic, aggregated data to draw on.
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 are identified, extracted, and catalogued in a standardized format.
Study types
- Case reports
- Case series
- Observational studies
Brings in
The published evidence base, gathered in one place.
Clinical submissions
Healthcare professionals submit de-identified cases through a structured template of aggregate clinical variables.
Reviewed before inclusion for
- Completeness
- Clinical plausibility
- Consistency
Brings in
Clinical experience that would otherwise go unpublished.
Why two sources
Real-world evidence alongside trials
Randomized controlled trials
One agent, a defined population, and a controlled comparison.
Registry evidence
Complexity, heterogeneity, and comorbidity of real patient populations.
A complementary evidence base
Trial efficacy read alongside outcomes from everyday practice.
Clinical scope
What the Registry Captures
The registry spans a broad range of immune-mediated inflammatory diseases and records the same set of clinical and demographic variables for every case, whether drawn from the literature or submitted by a clinician.
- Agents per case
- Two or more, at least one of which is a biologic
- Data sources
- Published literature and clinical submissions worldwide
- Identifiers
- None collected
Registry case record
De-identifiedPatient
De-identified demographics
Age bracket and sex.
Primary diagnosis
Disease category and relevant comorbid conditions.
Therapy
Advanced therapies
The concurrent agents prescribed, comprising biologics and targeted oral therapies. At least two agents per case, at least one of which is a biologic.
Duration of therapy
Length of concurrent advanced therapy.
Concomitant medications
Conventional systemic medications administered alongside the advanced therapies.
Outcome
Disease activity measures
OptionalAbsolute scores at baseline and follow-up, with the follow-up interval. Reported with completeness where available.
Validated instruments such as
- PASI
- BSA
- DAPSA
- ASDAS
- MDA
- LEI
Clinical outcome
Categorized on a standardized scale.
Scale
- Complete remission
- Well controlled
- Improvement
- Mixed
- 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
Cases that would otherwise remain isolated in single publications, or unreported in practice, are consolidated so patterns can be recognized.
Surfaces
- Which combinations
- In what contexts
- With what outcomes
Safety Signal Detection
Systematic capture of adverse events across therapy combinations offers early detection of concerns not apparent from monotherapy data alone.
Most valuable for
- Adverse events
- Untested combinations
- Beyond monotherapy
Toward Consensus
As the evidence base grows, aggregated data can inform consensus recommendations and best-practice guidance for concurrent prescribing.
Informs
- Consensus
- Best-practice guidance
- Across specialties
Open-Access Collaboration
An open, collaborative model lowers the barrier to contributing and accessing evidence, speeding its translation into clinical knowledge.
Promotes
- Transparency
- Knowledge sharing
- Across institutions
Leadership
Led by CMSD
The Concurrent Biologics Registry is led by Dr. Maksym Breslavets and managed through the Centre for Medical and Surgical Dermatology, supporting informed decision-making when concurrent biologic therapy is considered.
Governance
Registry oversight
- Registry director
Dr. Maksym Breslavets
- MD
- PhD
- FRCPC
- FAAD
- Managed through
Centre for Medical and Surgical Dermatology (CMSD)
- Registry operations
- Clinical oversight
- Role in practice
A quality assurance tool for clinical practice
- Informed decision-making
- When concurrent therapy is considered
Contributors
Project Contributors
The Concurrent Biologics Registry is built through clinical leadership, systematic literature review, and platform development.
Dr. Maksym Breslavets
Principal Investigator and Registry Director
Scientific direction of the registry, clinical review of submitted cases, and ongoing stewardship of the project objectives as the originating investigator.
Contributions
- Conceptualization
- Project administration
- Clinical oversight
- Registry governance
Chelsea Butler, BSc
Clinical Research Contributor
Medical student, University of Ottawa Faculty of Medicine
Structured searches of published concurrent therapy cases and ongoing curation of the foundational dataset across treatment, outcome, and demographic variables.
Contributions
- Literature review
- Data acquisition
- Data curation
Behind the Registry
Operated by CMSD, Built by Dermi
The Centre for Medical and Surgical Dermatology operates the registry. The technical platform was built and is maintained by Dermi, a Toronto-based healthcare technology company.
Operates
CMSD
Centre for Medical and Surgical Dermatology
Operates the registry and provides the clinical leadership and governance behind it.
Responsible for
- Registry operations
- Clinical leadership
Builds and maintains
Dermi
Toronto-based healthcare technology company
Built and maintains the technical platform, bringing its privacy-by-design approach to the registry.
Known for
- Local-first software
- Privacy by design
Principles applied to the registry
Privacy by design
Protections are enforced through architecture rather than policy alone.
Data minimization
While the registry is centrally hosted, only what is strictly necessary is collected.
Funding and compensation
- Free of charge
- No compensation
- No industry funding
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 scope, methodology, or content of the registry.
Outside of the registry, CMSD partners with Dermi to provide open-access clinical resources, including dermatology calculators such as PASI, EASI, VASI, and IHS4, freely available at cmsderm.ca/calculators.
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.
Read the Privacy PolicyCollected
Aggregate variables only
- Age bracket and sex
- Disease category
- Advanced therapies
- Duration of therapy
- Clinical outcomes
- Adverse events
Never requested
Identifiers of any kind
- Names
- Dates of birth
- Treatment dates
- Assessment dates
- Record numbers
- Addresses
Nothing that could enable patient re-identification is requested at any stage.