Biologics for Long-Term Treatment of Psoriasis Generally Safe

A German cohort study in Archives of Dermatological Research found that antipsoriatic drugs for treatment of moderate-to-severe psoriasis are generally safe over the long-term.

Although some minor discrepancies were found in the research, which used data from the PsoBest registry, in comparison with North American counterparts — including the Psolar registry – on the whole, there were no indications for elevated risks of using systemic or biologic drugs for psoriasis. For example, overall rates for neoplasms were 0.5/0.5 for systemic/biologics in PsoBest and 0.6/0.6 in Psolar, all data related to 100 patient years. Similarly, rates for all major cardiac events (MACE) were 1.0/0.8 in PsoBest and 1.1/1.3 in Psolar. Low-level differences were also observed in the rates of overall severe infections.

The finding is important, because treatment for moderate-to-severe psoriasis often lingers over years and sometimes decades. In addition, the powerful pharmacological agents used to treat it can be associated with significant adverse events (AEs) in some patients. In most countries, first-line systemic treatment includes methotrexate, ciclosporin A, and retinoids, and second line treatment includes the biologics infliximab, etanercept, ustekinumab, and adalimumab for plaque type psoriasis and psoriatic arthritis, and golimumab for psoriatic arthritis.

The study was designed to answer two key questions:

1. How is the overall safety of conventional systemic drugs and biologics in the treatment of moderate-to-severe psoriasis and psoriatic arthritis?

2. In particular, are there any differences between the various treatments with respect to safety signals on severe infections, malignancies and MACE?

The PsoBest registry includes adult patients with moderate-to-severe psoriasis at the time point of a new drug to be started. The observation time for the patient is 10 years, regardless of the treatment applied. Follow-up visits in the dermatology office were conducted in intervals of three months in the first half-year and every six months afterwards. In addition, three months after the physician visits, the patients were directly approached by mail for further information on the treatment status and patient reported outcomes. Patients without at least one follow-up visit were excluded from analysis, because of missing validation of therapy information.

Only prospectively observed events were considered in the analysis. Serious AEs were considered in the context of in-patient stay, life-threatening circumstances, neoplasms, and death. All events observed were divided into nine classes regarding infections, cardiovascular events, and malignancies.

Although the safety news is generally positive, there was a significant rate of comorbidity and co-medication in these patients compared to patients without psoriasis. Furthermore, patients receiving biologics showed significantly higher rates of relevant comorbidities such as cardiovascular disease, obesity, and diabetes.

The researchers addressed some limitations of the study, including the fact that “limitations of registries derive from the fact that there is no random assignment of treatments. Thus, different treatment groups may show structural inequalities, which can confound results. For this, direct comparisons between drugs are limited, if not adjusted for the inhomogeneities. In the current analysis, no specific adjustments for baseline differences were performed, since the unadjusted outcomes indicate very low rates of safety signals across all treatment arms.”

They also noted that safety outcomes on patients with moderate-to-severe psoriasis may not be transferable to patients exposed to these drugs with other diseases. That is, it has been shown that there is a different safety profile for different rheumatologic diseases.

“In contrast, the data’s strength is the non-selective character providing external validity and the systematic approach of nationwide solicited real-world safety data acquisition,” the researchers concluded.