LISBON – Roughly 85% of psoriasis patients re-treated with ustekinumab after withdrawing from an earlier successful course of therapy will experience an excellent response in round two.
This benefit was consistently seen in secondary analyses of two separate phase III clinical trials. This finding provides information that is valuable in clinical practice, Dr. Christopher E. Griffiths said at the annual congress of the European Academy of Dermatology and Venereology.
Dr. Christopher E. M. Griffiths
Psoriasis patients often have to halt effective biologic therapy for a variety of reasons – pregnancy, elective major surgery, vaccinations, or just to enjoy a welcome break from potent therapy while their disease has cleared – but not all biologics retain their efficacy upon re-treatment.
Ustekinumab (Stelara) now joins etanercept (Enbrel) and alefacept (Amevive) on the list of biologic therapies that are able to recapture their clinical response upon re-treatment, said Dr. Griffiths, professor of dermatology at the University of Manchester (England).
He reported on 260 ustekinumab-treated patients in the phase-III PHOENIX I trial and 375 in the ACCEPT trial, all of whom attained at least a 75% improvement, compared with baseline, in Psoriasis Area and Severity Index (PASI) scores, and a Physician Global Assessment (PGA) score of 0-2, meaning clear, minimal, or mild disease. The study patients were withdrawn from the biologic at week 40 in PHOENIX I and at week 12 in ACCEPT.
The PHOENIX I participants began re-treatment after losing at least 50% of the improvement obtained during the initial course of therapy. At week 12 of re-treatment, 84% of patients from PHOENIX I who were on the ustekinumab 45 mg dose and 85% on ustekinumab 90 mg achieved a PASI 75 response. The median improvement in PASI scores, compared with when they commenced re-treatment, was 89%-90%.
ACCEPT participants entered re-treatment after their PGA score, which was 0-2 upon treatment withdrawal, regressed to greater than 2.
Among ACCEPT participants undergoing re-treatment with ustekinumab 45 mg after earlier ustekinumab withdrawal, 85% were rated as having a 0-2 score on PGA at week 12. So were 89% on ustekinumab 90 mg. The median improvement in PASI scores from baseline was 85% in the ustekinumab 45 mg group and 90% in the ustekinumab 90 mg arm.
Rates of overall adverse events, serious adverse events, and infections were similar in the initial round of treatment and in re-treatment. No new safety signals arose during 12 weeks of re-treatment. Five patients being re-treated with ustekinumab 45 mg and two on ustekinumab 90 mg developed anti-ustekinumab antibodies; their response to re-treatment was significantly less robust than in patients without antibodies, Dr. Griffiths noted.
The study was funded by Centocor, the manufacturer of ustekinumab. Dr. Griffiths is an advisor to the company.