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Humira safety profile for psoriasis remains unchanged for 5 years

Humira continues to be a well-tolerated treatment, with no new safety signals observed during a 5-year review of an ongoing observational registry of patients with moderate-to-severe chronic plaque psoriasis, according to recently published research results.

Researchers collected data from ESPRIT, an ongoing 10-year observational registry, between Sept. 26, 2008, and Nov. 30, 2013. The analysis included 6,059 “all-treated” adults with moderate-to-severe chronic plaque psoriasis, who had received one or more Humira (adalimumab, AbbVie) doses in the registry, either continuing treatment from a current prescription or previous study participation. The patient population also included 2,580 patients (42.6%), who initiated adalimumab treatment within 4 weeks before registry enrollment and were classified as “new-prescription” population.

Median registry exposure was 765 days for the all-treated patients and 677 days for the new-prescription cohort. The rate of serious treatment-emergent adverse events inside or outside of the registry was 4.3 events per 100 patient-years of adalimumab exposure for the all-treated population. The rate of serious infections was 1 per 100 patient-years of exposure for the all-treated population, while the rate of malignancies was 0.9 per 100 patient-years of exposure: This included nonmelanoma skin cancers, with a rate of 0.6 events per 100 patient-years of exposure and melanomas, with a rate of less than 0.1 events per patient-years of exposure. The standardized mortality rate ratio was 0.3 (95% CI, 0.19-0.44). More than half of patients(57%) achieved physician global assessment of clear or minimal at 12 months of treatment., which was used as effectiveness parameter. At 5 years of treatment, 64.7% of patients achieved physician global assessment of clear or minimal.

The researchers wrote that the safety and treatment-effectiveness profiles were similar in the all-treated population and the new prescription population, which suggested “that the effectiveness and safety profiles of adalimumab are similar for patients whether treated in the physician’s office or in controlled, clinical trials.”

“Based on this profile, the known safety profile of adalimumab remains unchanged. Adalimumab demonstrated continued effectiveness over the registry’s first 5 years,” the researchers wrote. – By Bruce Thiel

Disclosure: Menter reports receiving grants and honoraria from AbbVie, Allergan, Janssen and Wyeth for participation on advisory boards and as a consultant, investigator and speaker,  from Stiefel as a consultant and investigator; receiving grants from Allergan, Celgene, Novarits, Novo Nordisk, Pfizer, and Syntrix Biosystems for participation as an investigator, from Eli Lilly as an investigator and consultant, receiving honoraria from Galderma as participant on advisory boards and as a consultant and investigator, and from Leo Pharma as a consultant and speaker. Please see the full study for a list of the other researchers’ relevant financial disclosures.