Review Documents 15 Years of Experience With Adalimumab in Psoriasis

This Psoriasis Awareness Month, a new review of real-world experience with adalimumab (Humira) in patients with psoriasis finds that adalimumab is slightly less safe, but has better effectiveness and drug survival, than other biologic treatment options.

The review focused on real-world studies published between 2015 and 2017, and used literature available from PubMed.

Click here to read more about biosimilars of adalimumab.

Adverse Events

A survey of adverse events (AEs) associated with adalimumab in the United States, Canada, and the Netherlands found that the rates of AEs ranged from 245 to 399 per 100 patient years, and serious AEs ranged from 6 to 23 per 100 patient years. Death occurred at a rate of 1 to 2 per 100 patient years. Taken together, these rates show that adalimumab is slightly less safe than etanercept, ustekinumab, or infliximab.

Local injection site reactions are common with adalimumab, affecting 12% to 37% of patients, and usually occur within the first month of treatment. Combination therapy with methotrexate rather than monotherapy, however, appears to reduce these reactions.

Despite the possibility of AEs, 1 study found that adalimumab has drug survival rates of 64% at week 16, 58% at month 6, and 53% at year 1, and effectiveness—rather than safety issues—was the only independent predictor of drug survival.

Immunogenicity

Treatment interruption, low trough adalimumab concentration, switching among other biologics, and the absence of methotrexate have all been identified as risk factors of development of antidrug antibodies, and 1 study found that antibody formation contributes to treatment failure in adalimumab more than it does in etanercept.

Infections

In industrialized countries, a rate of 1.5 to 2.0 serious infections per 100 patient years has been observed, though tuberculosis remains a concern, especially in countries that have a high prevalence of tuberculosis. Screening for latent infection is recommended before initiating any systemic biologic, including adalimumab.

Similarly, hepatitis and HIV may be reactivated under adalimumab treatment, though a link between adalimumab and certain rare infections, such as deep fungal infections or histoplasmosis, remains unestablished.

Malignancies

Because psoriasis is linked with an increased risk of malignancies, it is difficult to assess an increased risk of malignancy with adalimumab treatment. To date, an increased risk of melanoma with adalimumab has only been described rarely in patients with rheumatoid arthritis, which suggests that, in psoriasis, other factors—like prior UV light therapy—may have a role in any elevated rates of skin cancer.

Concomitant Disease

Many patients with psoriasis treated in the real-world setting have concomitant disease that benefits from adalimumab. These disorders include Crohn disease, hidradenitis suppurativa, and inflammatory arthritis. Additionally, depression, which is common in patients with psoriasis, appears to improve with successful biologic treatment.

Cardiovascular events are linked with psoriasis, and the use of adalimumab should be avoided in those patients who have moderate or severe heart failure.

In the case of renal failure, some case studies have shown adalimumab to be safe and not to interfere with the course of the disease.

Special Groups

Less is known about adalimumab in pregnant or lactating women, or in children or the elderly. However, according to the review, current safety data for antiagents in general suggest that these agents can be used from conception to the first trimester, and that they may be safe during lactation.

In children with psoriasis, data suggest, etanercept or ustekinumab may be more effective than adalimumab. In elderly patients, adalimumab has been demonstrated to be safe and effective for long-term treatment.

Reference

Sator P. Safety and tolerability of adalimumab for the treatment of psoriasis: a review summarizing 15 years of real-life experience. Ther Adv Chronic Dis. 2018;9(8); 147-158. doi: 10.1177/2040622318772705.