Responses to ustekinumab in the anti-TNF agent-naïve vs. anti-TNF agent-exposed patients with psoriasis vulgaris.

BACKGROUND

Approximately 20-30% of patients with psoriasis treated with anti-tumour necrosis factor α (TNFα) agents will discontinue treatment within 2 years due to loss of efficacy or side-effects. Switching to another anti-TNFα agent produces clinical responses inferior to previously untreated patients. Ustekinumab binds to the p40 subunit of interleukin (IL)-12 and IL-23 and provides a mechanism of action independent of TNFα.

OBJECTIVE

To investigate the efficacy of ustekinumab in a clinical practice setting and to compare treatment responses to ustekinumab in patients previously treated with TNFα inhibitors and anti-TNFα-naïve patients.

METHODS

Patients receiving either ustekinumab (n=71) or the subcutaneous TNFα inhibitors adalimumab or etanercept (n=108) were identified through the registry of psoriasis patients in our Institutions. Efficacy effect outcome was a 75% improvement in the psoriasis area severity index (PASI75). Kaplan-Meier statistics evaluated the adherence to the treatments expressed as drug survival rate.

RESULTS

PASI75 was achieved in 80% of the ustekinumab-treated patients after a median time of 112 days. There was no difference in efficacy in anti-TNFα-naïve patients compared with anti-TNFα unresponsive patients. Patients treated with ustekinumab showed a superior adherence to treatment in comparison with adalimumab and etanercept.

LIMITATIONS: Patients were non-randomly assigned to treatment, which potentially may lead to biases. Observation time was short (1 year).

CONCLUSION

In clinical practice, the short-term efficacy and patient adherence to ustekinumab are excellent and comparable to the data obtained in clinical trials. Lack of response to previous anti-TNF treatment does not impair clinical response to ustekinumab.