Risk of adverse events of psoriasis treatment with biologic agents and new small molecules-BIOBADADERM Registry.

BACKGROUND

Registry studies are needed to provide comprehensive and updated assessments of the long-term safety profiles of systemic drugs in psoriasis.

OBJECTIVES

To analyse the safety of biologic drugs and new oral molecules used for the treatment of moderate-to-severe psoriasis in patients included in the Spanish Registry of Adverse Events of Biological Therapy (BIOBADADERM), compared to that of adalimumab.

METHODS

Prospective, multicentre cohort of patients with psoriasis. The safety profiles of biologic agents (etanercept, infliximab, adalimumab, certolizumab, ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab, risankizumab and tildrakizumab), apremilast and dimethyl fumarate were studied. The incidence rate ratio (IRR) and adjusted IRR of specific adverse events were assessed for each drug, using adalimumab as a reference. Propensity scores were used to adjust for selection bias.

RESULTS

Our study included 4212 patients (7590 treatment cycles; 17,284 patient-years of follow-up). Adalimumab had an incidence rate for all adverse events of 614 per 1000 patient-years (95% confidence interval [CI] (591; 637)). The risk of all adverse events was significantly lower for guselkumab (adjusted IRR [aIRR] 0.56, 95% CI (0.47; 0.67)), risankizumab (aIRR 0.59, 95% CI (0.48; 0.71)), tildrakizumab [aIRR 0.6, 95% CI (0.46; 0.8)], ixekizumab (aIRR 0.65, 95% CI (0.56; 0.76)) and ustekinumab (aIRR 0.73 95% CI (0.65; 0.82)) compared to adalimumab (p ≤ 0.002), as well as the risk for some specific organ-based groups of adverse events. Conversely, the risk for all adverse events was significantly higher for dimethyl fumarate (aIRR 3.67, 95% CI (2.71; 4.97)), infliximab (aIRR 1.88, 95% CI (1.45; 2.43)) (p ≤ 0.002) and apremilast (aIRR 1.27, 95% CI (1.05; 1.53)) (p 0.012). The risk of malignant neoplasms was significantly reduced in the group treated with ixekizumab (aIRR 0.14 95% CI (0.04; 0.47)).

CONCLUSIONS

Our data support that, overall, the new biologic treatments have a superior safety profile in real-world practice compared to adalimumab and its biosimilars.