The safety profile of biologic agents in comparison with non‐biologic systemic agents, and topical compounds in the management of psoriasis—A 30‐month prospective, observational cohort study

• Published in: International journal of clinical practice (Esher) Vol. 75; no. 12; pp. e14915 - n/a
• Main Authors: Marques, Emanuel, Paluch, Zoltán, Boháč, Petr, Slanař, Ondřej, Běláček, Jaromír, Hercogová, Jana
• Format: Journal Article
• Language: English
• Published: England Hindawi Limited 01.12.2021
• Subjects: Adverse events; Biological Factors; Clinical trials; Cohort analysis; Connective tissues; Dermatologic Agents - adverse effects; Humans; Infections; Observational studies; Oral cavity; Patients; Prospective Studies; Psoriasis; Psoriasis - drug therapy; Severity of Illness Index; Treatment Outcome
• ISSN: 1368-5031; 1742-1241
• DOI: 10.1111/ijcp.14915

Background Although biologic agents (BAs) are very effective, solid data proving they are safer than other therapies in psoriasis are still lacking. Methods A total of 289 psoriatic patients were followed for 30 months; of which number 118 were treated with topical agents alone, 112 received BAs, and the remaining 59 patients were on non‐biologic systemic agents (NBSAs). The rates of adverse events in these groups were recorded and statistically analysed. Results Patients treated with BAs had higher rates of adverse events (P = .017), including overall infections (P = .003), respiratory infections (P < .001), renal, urinary (P < .001), musculoskeletal, connective tissue (P < .001, and P = .021) and oral cavity‐related (P = .046) disorders. Except for the incidence of infections, all the above adverse events occurred more often in our study than in clinical trials. The occurrence of serious adverse events was P = .066, with the incidence of serious infections being P = .164. Unlike patients on topical therapy and NBSAs, patients treated with BAs were forced to discontinue their therapies (P = .001). The Psoriasis Area Severity Index (PASI) and body surface area (BSA) scores were the lowest among patients on BAs. Conclusion While BAs were the most effective therapies, they were associated with higher rates of treatment discontinuation and adverse events in comparison with other forms of therapy.