Sex differences in adverse events from systemic treatments for psoriasis: A decade of insights from the Swiss Psoriasis Registry (SDNTT)

Abstract

BackgroundPsoriasis is a disease that often requires prolonged systemic treatment. It is important to determine the safety of available therapies. There is currently little insight into sex‐specific differences in the safety of systemic psoriasis therapies.ObjectivesTo examine the real‐world, long‐term safety of systemic psoriasis therapies with sex stratification in drug‐related adverse events (ADRs).MethodsTen‐year data from adults with moderate‐to‐severe psoriasis requiring systemic treatment (conventional systemic therapies [CST], biologics) were obtained from the Swiss psoriasis registry (SDNTT). ADRs were categorized according to the international terminology Medical Dictionary for Regulatory Activities (MedDRA). Safety was assessed by calculating event rates per 100 patient‐years (PY). We used descriptive statistics for patient and disease characteristics, and binomial and t‐tests to compare treatment groups and sex.ResultsIn total, 791 patients (290 females) were included with a mean age of 46 years. 358 (45%) received CSTs and 433 (55%) biologics; both groups had similar baseline characteristics except for more joint involvement in patients using biologics (26.86% vs. 14.8%, p < 0.0001). CSTs were associated with a 2.2‐fold higher ADR rate (40.43/100 PY vs. 18.22/100 PY, p < 0.0001) and an 8.0‐fold higher drug‐related discontinuation rate than biologics (0.16/PY vs. 0.02/PY, p < 0.0001). Trends showed non‐significant higher serious adverse event rates per 100 PY for biologics (8.19, CI 6.87–9.68) compared to CSTs (7.08, CI 5.39–9.13) (p = 0.3922). Sex stratification revealed a significantly higher overall ADR rate for all treatments in females (1.8‐fold for CSTs [57.30/100 PY vs. 31.69/100 PY] and 2.0‐fold for biologics [27.36/100 PY vs. 13.9/100 PY], p < 0.0001), and drug‐related discontinuation rates for most CSTs in females.ConclusionFemales were associated with a significantly higher rate of ADRs and drug‐related discontinuation rates. Sex stratification should be taken into consideration when designing studies in the patient‐tailored management of psoriasis.

Sex Differences in Cardiac and Clinical Phenotypes and Their Relation to Outcomes in Patients with Heart Failure

“…ADRs were reported to be more frequent among women than men at all ages, and the symptoms of ADR were more highly divergent in women [84,85]. Moreover, the discontinuation of drugs due to ADRs was more frequent in women than men [86,87]. One of the possible mechanisms which can explain that women are more likely to experience ADRs than men could be the sex-related differences in pharmacokinetics.…”

Sex stratification of adverse events should be included in studies about skin disease

“…4 The Swiss Psoriasis Registry (SDNTT) reported recently the sex differences in adverse events from a decade of data from systemic treatments for psoriasis. 5 A total of 791 patients (290 females, 36.7%) were included with a mean age of 46 years. 358 (45%) received conventional systemic treatments and 433 (55%) biologics; both groups had similar baseline characteristics except for more joint involvement in patients using biologics (26.86% vs. 14.8%, p < 0.0001).…”