The risk of infection and malignancy with tumor necrosis factor antagonists in adults with psoriatic disease: A systematic review and meta-analysis of randomized controlled trials

Abstract

Background There is a need to better understand the safety of TNF inhibitors in patients with psoriatic disease in whom TNF inhibitors are frequently used as monotherapy. Objective Examine the risks of infection and malignancy with the use of TNF antagonists in adult patients with psoriatic disease. Methods Systematic search for trials of TNF antagonists for adults with plaque psoriasis (PsO) and psoriatic arthritis (PsA). We included randomized, placebo-controlled trials of etanercept, infliximab, adalimumab, golimumab, and certolizumab for the treatment of PsO and PsA. 20 out of 820 identified studies with a total of 6,810 patients were included. Results were calculated using fixed effects models and reported as pooled odds ratios (OR). Results ORs for overall infection and serious infection over a mean of 17.8 weeks were 1.18 (95% CI: 1.05, 1.33) and 0.70 (95% CI: 0.40, 1.21), respectively. When adjusting for patient-years, the incidence rate ratio for overall infection was 1.01 (95% CI: 0.92, 1.11). The OR for malignancy was 1.48 (95% CI: 0.71, 3.09), and 1.26 (95% CI: 0.39, 4.15) when non-melanoma skin cancer was excluded. Limitations Short duration of follow-up and rarity of malignancies and serious infections. Conclusions There is a small increased risk of overall infection with the short-term use of TNF antagonists for psoriasis that may be attributable to differences in follow-up time between treatment and placebo groups. There was no evidence of an increased risk of serious infection and a statistically significant increased risk in cancer was not observed with short-term use of TNF inhibitors.

The Long-Term Safety of Adalimumab Treatment in Moderate to Severe Psoriasis

“…For example, the role of anti-inflammatory cytokines has often been raised in the context of host defense against serious infections, as well as other adverse events of interest. [6] In the absence of long-term results from large patient registries, the availability of long-term safety data from clinical trials of therapeutics in psoriasis is particularly important.…”

Dermatotherapeutic Agents

“…Nonetheless, no serious risks for these conditions were identified in a population of over 6000 psoriasis patients treated with various TNF-a inhibitors for up to 30 weeks duration [56].…”

A decade of biologics in dermatology

“…Zu den substanziellen Fragen im Zusammenhang mit Biologics, die berechtigterweise immer wieder gestellt werden müssen, wie Infektionsrisiko, Malignominduktion, Antikörperproduktion, Medikamentenadhärenz und Mortalität liegen gegenwärtig für die einzelnen Biologics viele Studiendaten vor, deren Ergebnisse global überwiegend relative Sicherheit reflektieren [7,10,31,36].…”