International journal of clinical practice · 2021
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.
СтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Marques Emanuel, Paluch Zoltán, Boháč Petr, Slanař Ondřej, Běláček Jaromír, Hercogová Jana
Аннотация
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.
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.