Summary

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• Stelara (ustekinumab) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy; for adults with active psoriatic arthritis (PsA); for adult patients with moderately to severely active Crohn's disease (CD); for adult patients with moderately to severely active ulcerative colitis; and for the treatment of pediatric patients 6 years and older with moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy, or active psoriatic arthritis (PsA).
• This summary is based on the review of 64 systematic review(s)/meta-analysis(es). ^[1-64]
• Crohn's Disease (CD): Ustekinumab (UST) is effective in treating refractory CD patients, particularly those unresponsive to traditional immunosuppressive therapies or TNF-α antagonists. UST maintains fistula response but is not superior to anti-TNF agents for induction and maintenance of fistula response. UST also ranks as an effective treatment for maintaining endoscopic remission in CD compared to placebo.
• Ulcerative Colitis (UC): UST has lower clinical remission rates than infliximab and vedolizumab at 6-14 weeks and 52-54 weeks. It is less effective than upadacitinib, TNF antagonists, and filgotinib for early symptomatic remission. UST shows efficacy but ranks lower than upadacitinib and other advanced therapies for inducing clinical remission in UC patients.
• Psoriatic Arthritis (PsA): UST effectively reduces radiographic progression in PsA, comparable to other biologic disease-modifying antirheumatic drugs (bDMARDs). It also lowers the rate of psoriatic arthritis development in psoriasis patients.
• Psoriasis: UST is less effective than newer biologics like risankizumab in achieving PASI100 and PASI90 in both short- and long-term settings. It also has lower efficacy compared to ixekizumab and secukinumab in long-term PASI outcomes.
• General Safety: UST did not show a significant increase in short-term risk of adverse events compared to placebo in conditions like Crohn's disease (CD) and ulcerative colitis (UC).
• Safety in Dosing Regimens: The Q12W regimen of UST demonstrated better safety outcomes with significantly fewer adverse events compared to the Q8W regimen.
• Infection Risk: UST was associated with a lower risk of infections compared to other biologics, such as adalimumab, ixekizumab, and secukinumab.
• Surgical Safety: Preoperative use of UST in CD patients did not increase the risk of surgical complications compared to anti-TNF agents and vedolizumab.
• Biologic-naïve patients with Crohn's Disease and Ulcerative Colitis demonstrated higher efficacy in response to UST compared to biologic-experienced patients.
• Patients with psoriasis who are positive for HLA-C06:02 exhibited higher PASI75 response rates to UST compared to those with negative HLA-C06:02 status.