Safety and tolerability of adalimumab for the treatment of psoriasis: a review summarizing 15 years of real-life experience

Abstract

Biologic therapies like adalimumab are the gold standard for psoriasis treatment with efficacy and safety profiles allowing for long-term treatment. However, adalimumab cannot be used in all patients and may cause adverse drug reactions. This study reviews conditions that might limit the use of adalimumab under real-life conditions. Local injection site reactions affect 12-37% of patients but rarely require specific therapy. Dermatological adverse events (AEs) include the paradoxical psoriasis and tend to respond to adequate therapy without adalimumab discontinuation. Adalimumab increases the risk for infections; latent chronic infections like tuberculosis or hepatitis B/C impose the highest risk for serious AEs. However, administration of adalimumab may still be possible under appropriate monitoring or prophylactic therapy. Some studies indicate an increased risk of malignancies in patients with psoriasis exposed to adalimumab. Here, the causal relationship is unclear since both psoriasis and some first-line therapies increase the risk of malignancies. Depression frequently coincides with psoriasis and may respond to adalimumab as well. Cardiovascular diseases are contraindications for adalimumab, but evidence suggests that adalimumab may still be a treatment option. Overall AE rates range from 245 to 399 per 100 patient years (serious AEs: 6-23; death: 1-2). Thus, adalimumab is slightly less safe than ustekinumab and infliximab but exhibits superior effectiveness and drug survival. Adalimumab is safe for pregnant women during the first trimester, for children up to 4 years and for the elderly. Thus, in spite of several conditions that require specific attention, the favourable safety and tolerability of adalimumab for the treatment of psoriasis is confirmed.

Keywords: adalimumab; adverse drug reaction; antidrug antibodies; biologica; local injection site reaction; long-term safety; opportunistic infection; protected patient groups; safety profile; special patient populations; tumour necrosis factor α.