Sunday, June 30, 2013

Ustekinumab at the EULAR 2013 Meeting

Ustekinumab (Stelara) is a human monoclonal antibody against IL-12 and IL-23. Adverse events include an increased risk of infections (tuberculosis and others) and cancer. There were a couple of studies on Ustekinumab and I've been eager to know, whether these studies confirmed the positive impressions, the drug had made last year. I didn’t see the solution of problems treating psoriatic arthritis in ustekinumab, but thought of getting a new option to treat at least some patients with psoriatic arthritis better than before (ACR 2012). Now let’s switch to the newer studies or new results.

P. Rahman an colleagues presented a study [SAT0264]: "Ustekinumab [UST] improves physical function, quality of life and work productivity of patients with active psoriatic arthritis who were naïve to MTX, despite MTX therapy or previously treated with anti-TNFα: results from PSUMMIT I and PSUMMIT II". Conclusions: "UST improves physical function, improves general, arthritis and skin-related quality of life, and reduces the impact of disease on work productivity in patients with active PsA regardless of current or prior MTX use or prior anti-TNF experience." If you expected differences in patients naïve to anti-TNFα, your're right. In results we find: " In the anti-TNF naïve population, statistically significantly greater improvement in SF-36 MCS was observed in the combined UST 45mg and 90mg group vs PBO."

I. McInnes and colleagues presented [SAT0267]: "Safety of ustekinumab from the placebocontrolled periods of psoriatic arthritis and psoriasis clinical developmental programs". The conclusions as expected: " During the PBO-controlled portion, UST was well-tolerated. Overall safety were consistent between populations & safety event rates were generally comparable between pts receiving PBO & UST within each population."

K. Papp and colleagues looked at long-term safety [SAT0287]: "Long-term safety of ustekinumab: 5 years of follow-up from the psoriasis clinical development program including patients with psoriatic arthritis". Conclusions: "With continuous UST exposure for up to 5yrs and approximately 9000 pt-years of follow-up in the PsO development program, long-term safety in the Overall Population were consistent with previous reports at earlier follow-up and event rates were generally comparable to other currently approved biologic agents. Long-term safety in the sub-group of PsO patients with a history of PsA at baseline were generally comparable to those in the overall study population." Nothing unexpected, but this look on safety makes one feel safe to prescribe the drug later.

C. Ritchlin and colleagues presented the following study [OP0001]: "Maintenance of efficacy and safety of ustekinumab in patients with active psoriatic arthritis despite prior conventional nonbiologic and anti-TNF biologic therapy: 1 yr results of the PSUMMIT 2 trial". The highest ACR70 was reached in the 90 mgs group at 17.9%. Conclusions: "Both UST doses (45/90 mg q12w) yielded significant and sustained improvements in PsA signs/symptoms with favorable and comparable safety profiles. UST was effective in both anti-TNF-naïve and anti-TNF-experienced pts, with greater efficacy in anti-TNF naïve pts and anti-TNFexperienced pts previously treated with 1 or 2 anti-TNF agents."

It seems we're getting a new drug to treat psoriatic arthritis - now let's wait for if and when FDA and EMEA approve ustekinumab.

ACR 2012 in Washington


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