Infliximab is safe and effective for treating psoriasis, results from phase 4 study presented at the 2014 American Academy of Dermatology Annual Meeting indicate.

Neil Shear, MD, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, presented results from the Real-World Assessment of Long-Term Infliximab Therapy for Psoriasis (REALITY) study.

The researchers found that 56.8% of patients with plaque-type psoriasis treated who were treated with infliximab achieved 75% improvement in Psoriasis Area and Severity Index (PASI 75) by week 50.

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This 50-week analysis of efficacy and safety of infliximab maintenance therapy in patients with plaque-type psoriasis in real-world practice evaluated the efficacy and safety of maintenance infliximab 5 mg/kg. The study also included a 48-week extended treatment phase for a total duration of 98 weeks.

The prospective, observational, open-label, multicenter study involved 660 patients with plaque-type psoriasis. Infliximab was infused per local labeling, with induction doses given at weeks 0, 2 and 6, and maintenance doses given every week. Mean patient age was 46 years; 65% were male.

Mean baseline PASI score was 18.1, and 296 (57%) patients achieved PASI 75 response at week 50 (95% CI: 52.5%-61.0%), according to the findings in the abstract. This response rate at week 50 was higher among the 302 patients without previous treatment with biologic agents (67%) compared with the 219 patients with biologics exposure (43%).

Regarding sustained response rates, 57% of patients with PASI 90 response rate at week 14 had the same rate at 50 weeks. Sixty-five percent of patients with a PASI 75 response rate at week 14 had the same at week 50, and 70% of patients with a 50% response rate at week 14 had the same level of response at week 50.

Infliximab was generally well tolerated; 36% of patients reported adverse events and 8% reported serious adverse events.

Common adverse events included arthralgia and headache (3% each). Four deaths occurred, including one death from lung cancer that investigator considered to be possibly linked to the study drug. Three additional deaths were attributed to cardiac respiratory failure, lung cancer and cardiac decompensation and were considered unrelated to treatment.


  1. Shear N. Abstract #P8353. Presented at: AAD 2014; March 21-25, 2014; Denver.

Disclosure: Merck Sharp & Dohme Corp sponsored this study.