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
Abstract
BACKGROUND: Although biologic agents 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 biologic agents, and the remaining 59 patients were on non-biologic systemic agents.
The rates of adverse events in these groups were recorded and statistically analyzed. RESULTS: Patients treated with biologic agents had higher rates of adverse events (p=0.017), including overall infections (p=0.003), respiratory infections (p<0.001), renal, urinary (p<0.001), musculoskeletal, connective tissue (p<0.001, and p=0.021) and oral cavity-related (p=0.046) 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=0.066, with the incidence of serious infections being p=0.164.
Unlike patients on topical therapy and non-biologic systemic agents, patients treated with biologic agents were forced to discontinue their therapies (p=0.001). The Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA) scores were the lowest among patients on biologic agents.
CONCLUSION: While biologic agents were the most effective therapies, they were associated with higher rates of treatment discontinuation and adverse events in comparison with other forms of therapy.