ArticleDrug safety2014
Safety profile of biological medicines as compared with non-biologicals: an analysis of the italian spontaneous reporting system database.
Article in Drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 45 citations in OpenAlex.
- Incidence rates of tuberculosis and inflammatory bowel disease in patients with ankylosing spondylitis treated with biologics in Korea.Rheumatology (Oxford, England) · 2025Article
- Hepatobiliary disorders associated with TNF-α inhibitors: a pharmacovigilance analysis of FAERS and JADER.Frontiers in immunology · 2025Article
- Prescribing Pattern and Safety Profile of Biological Agents for Psoriasis in Real-World Practice: A Four-Year Calabrian Pharmacovigilance Analysis.Pharmaceutics · 2024Article
- Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems.Frontiers in drug safety and regulation · 2023Review
- Biosimilars in Oncology: Latest Trends and Regulatory Status.Pharmaceutics · 2022Review
- Rituximab and Pyoderma Gangrenosum: An Investigation of Disproportionality Using a Systems Biology-Informed Approach in the FAERS Database.Drugs - real world outcomes · 2022Article
- Biologics for Inflammatory Bowel Disease in Clinical Practice: A Calabria (Southern Italy) Prospective Pharmacovigilance Study.Pharmaceutics · 2022Article
- Large-Scale Postmarketing Surveillance of Biological Drugs for Immune-Mediated Inflammatory Diseases Through an Italian Distributed Multi-Database Healthcare Network: The VALORE Project.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Article
- Switching TNFα inhibitors: Patterns and determinants.Pharmacology research & perspectives · 2021Article
- Safety Profile of Monoclonal Antibody Compared With Traditional Anticancer Drugs: An Analysis of Henan Province Spontaneous Reporting System Database.Frontiers in pharmacology · 2021Article
- Lessons to be Learnt from Real-World Studies on Immune-Related Adverse Events with Checkpoint Inhibitors: A Clinical Perspective from Pharmacovigilance.Targeted oncology · 2020Review
- Safety Profile of Biologics Used in Rheumatology: An Italian Prospective Pharmacovigilance Study.Journal of clinical medicine · 2020Article
- Article
- Safety profile of biologic drugs for psoriasis in clinical practice: An Italian prospective pharmacovigilance study.PloS one · 2020Article
- Article
- Toxicities with Immune Checkpoint Inhibitors: Emerging Priorities From Disproportionality Analysis of the FDA Adverse Event Reporting System.Targeted oncology · 2019Observational
- Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice.Clinical pharmacology and therapeutics · 2019Article
- Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction.Drug safety · 2018Review
- Challenges and Opportunities for the Traceability of (Biological) Medicinal Products.Drug safety · 2018Article
- Comparative risk/benefit profile of biosimilar and originator erythropoiesis-stimulating agents (ESAs): data from an Italian observational study in nephrology.European journal of clinical pharmacology · 2018Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBiologicals are important treatment options for various chronic diseases. After the introduction of the first biosimilars, animated debate arose in the scientific community about the actual benefit-risk profile of these drugs. In this context, a comparative safety evaluation of biologicals and biosimilars in clinical practice is warranted.
methodsWe identified all suspected adverse drug reactions (ADRs) concerning biological/biosimilars (excluding vaccines, toxins, blood derivatives, and radio-pharmaceuticals), and further classified them into mechanistic classes. We described the frequency of biological/biosimilar class- and compound-specific ADRs by system organ class (SOC) and type of reporter. We also separately explored the traceability of biologicals and biosimilar-related ADR reports.
resultsOverall 171,201 ADR reports were collected during the observation period; 9,601 (5.6 %) of these concerned biologicals. Biological-related reports were mainly issued by hospital-based physicians (78.7 %). Most of these reports involved monoclonal antibodies and fusion proteins (66.3 %). Reported ADRs were mainly 'skin and subcutaneous tissue disorders' (21 %), 'general and administration site disorders' (17 %), and 'gastrointestinal disorders' (13.6 %). In terms of traceability, 94.8 % of biological-related reports included an identifiable product name, whilst only 8.6 % indicated the corresponding batch number. Regarding biosimilars, 298 reports were identified, with a low proportion indicating drug ineffectiveness (10.1 %).
conclusionsMost ADRs attributed to biologicals are 'skin and subcutaneous tissue disorders'. Anticancer monoclonal antibodies are most frequently associated with ADRs. A low proportion of ADR reports concern biosimilars.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.