Stelara a new treatment option for this patient population
By Phoebe Starr
Madrid, Spain—One-year open-label follow-up of the phase 3 PSUMMIT 2 trial showed that the early improvement that was achieved by week 24 with ustekinumab (Stelara), an interleukin (IL)-2 and IL-23 antagonist, was sustained at week 52 in patients with psoriatic arthritis who had previously received as well as those who had not previously received an anti–tumor necrosis factor (TNF) inhibitor, said lead investigator Christopher T. Ritchlin, MD, MPH, Chief, Division of Allergy, Immunology and Rheumatology, University of Rochester Medical Center, NY, at the 2013 European League Against Rheumatism annual meeting.
Madrid, Spain—One-year open-label follow-up of the phase 3 PSUMMIT 2 trial showed that the early improvement that was achieved by week 24 with ustekinumab (Stelara), an interleukin (IL)-2 and IL-23 antagonist, was sustained at week 52 in patients with psoriatic arthritis who had previously received as well as those who had not previously received an anti–tumor necrosis factor (TNF) inhibitor, said lead investigator Christopher T. Ritchlin, MD, MPH, Chief, Division of Allergy, Immunology and Rheumatology, University of Rochester Medical Center, NY, at the 2013 European League Against Rheumatism annual meeting.
In September 2013, the US Food and Drug Administration (FDA) approved ustekinumab (Stelara), alone or in combination with methotrexate, for the treatment of adult patients with active psoriatic arthritis (see page 4). Ustekinumab was previously approved by the FDA for adult patients with moderate-to-severe psoriasis.
Ustekinumab is a good treatment option for patients who fail to respond to anti-TNF therapy. Heretofore no good options were available for such patients, who represent a substantial population, Dr Ritchlin said. “Now an alternative drug has demonstrated improvements not just in anti-TNF–naïve patients, but also in those who have been treated with one or more anti-TNF agent,” he said.
Study Results
The study included 312 patients randomized to 1 of 3 arms—placebo, ustekinumab 45 mg daily, and ustekinumab 90 mg daily. Patients received ustekinumab at week 0, week 4, and week 16, followed by every 12 weeks up to week 40, or placebo at week 0, week 4, and week 16, followed by a crossover to ustekinumab 45 mg for week 24, week 28, and week 40. Of the 312 patients, 180 were previously exposed to between 1 and 5 anti-TNF agents.
In the 24-week results of PSUMMIT2, ustekinumab led to a significantly better American College of Rheumatology 20% criteria for improvement (ACR20) response compared with placebo (P <.001).
ACR20 response was sustained from week 24 in an open-label trial in which all patients received ustekinumab 45 mg or 90 mg. ACR20 responses with ustekinumab at week 52 were 46.8% in the lower-dose arm and 48.4% in the higher-dose arm.
Although responses were observed in all patients, the rate was higher in the anti–TNF-naïve patients versus in previously anti-TNF inhibitor–treated patients. ACR20 was achieved by 59% to 73% of the patients in the treatment-naïve group versus by 37% to 41% of patients in the treatment-experienced group.
Ustekinumab treatment also improved physical function according to the Health Assessment Questionnaire-Disability Index. Skin involvement with psoriatic plaque was improved by at least 75% on the Psoriasis Area and Severity Index (PASI 75), and the drug improved dactylitis and enthesitis. No new ustekinumab-related safety concerns emerged in this trial.
Overall ACR50 response at week 52 was 29% for the placebo group assigned to 45 mg of ustekinumab, 28% for ustekinumab 45 mg, and 26% for ustekinumab 90 mg. ACR70 response rates were 16%, 12%, and 18%, respectively. PASI 75 was seen in 56%, 57%, and 84% of patients, respectively.
Ustekinumab was well tolerated, with no deaths, tuberculosis, or opportunistic infections being reported through 60 weeks of the study. No new safety signals were reported related to ustekinumab.