Ming-Chun Hsu

Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up.

Summary Background  Long‐term safety evaluations of biologics are needed to inform patient management decisions.

Cardiovascular safety of ustekinumab in patients with moderate to severe psoriasis: results of integrated analyses of data from phase II and III clinical studies

Background  Patients with psoriasis are believed to be at an increased risk of cardiovascular (CV) morbidity, and the effect of biological agents on CV safety is not fully understood.

Long-term efficacy and safety of ustekinumab, with and without dosing adjustment, in patients with moderate-to-severe psoriasis: results from the PHOENIX 2 study through 5 years of follow-up

Evaluation of the dosing flexibility and long‐term efficacy of biological agents is limited.

Underdiagnosis and undertreatment of cardiovascular risk factors in patients with moderate to severe psoriasis

BACKGROUND Patients with psoriasis are known to have an increased number of cardiovascular (CV) risk factors and be at increased risk for CV events. OBJECTIVES We sought to describe and characterize the underdiagnosis and undertreatment of CV risk factors in patients with moderate to severe psoriasis. METHODS Medical histories including diabetes, hypertension, and hyperlipidemia were obtained from 2899 patients in 3 phase III ustekinumab trials, a therapeutic anti-interleukin (IL)-12/IL-23p40 monoclonal antibody. Reported history was compared with measured fasting glucose, fasting lipids, and blood pressure. Ten-year Framingham risk scores and the proportion of patients achieving glycemic, lipid, and blood pressure targets were evaluated. RESULTS Significant risk factors existed in patients with moderate to severe psoriasis (58.6% and 28.8% of patients had ≥ 2 and ≥ 3 established CV risk factors, respectively). Based on Framingham risk score, 18.6% of patients were at high risk and 12.3% were at intermediate risk for CV events. At baseline, a small proportion of patients with diabetes (2.3%), hypertension (9.1%), or hyperlipidemia (4.9%) were previously without a diagnosis. However, 19.1%, 21.8%, and 38.6% of patients with diabetes, hypertension, or hyperlipidemia, respectively, were untreated at baseline, and the proportion at treatment goal was not ideal (hypertension 59.6% and hyperlipidemia 69.7%), especially for diabetes (36.7%). LIMITATIONS Results are based on a clinical trial population and findings may not be generalizable to the general psoriasis population. CONCLUSIONS In this moderate to severe psoriasis population, a high prevalence of undiagnosed and undertreated CV risk factors existed, emphasizing the importance of screening patients with psoriasis for CV risk factors.

Extension of ustekinumab maintenance dosing interval in moderate‐to‐severe psoriasis: results of a phase IIIb, randomized, double‐blinded, active‐controlled, multicentre study (PSTELLAR)

Phase III studies showed that some patients maintained response for ≥ 6 months following ustekinumab discontinuation.

Ustekinumab and Marked Clinical Responses in Patients with Moderate to Severe Psoriasis

Background Ustekinumab has demonstrated significant efficacy and favorable safety in patients with moderate to severe psoriasis. Objective Characterization of patients achieving marked clinical responses (Psoriasis Area and Severity Index [PASI] 90 or Physicians Global Assessment [PGA] of cleared) in two double-blind, placebo-controlled, phase III studies. Methods PHOENIX 1 (n=766) and PHOENIX 2 (n=1,230) patients were randomized to receive placebo or ustekinumab 45 or 90 mg at weeks 0 and 4, then every 12 weeks. At week 12, placebo patients crossed over to ustekinumab. Marked responses, defined as PASI 90 or PGA of cleared, are reported. Results A significantly higher proportion of ustekinumab-treated patients in PHOENIX 1 (39.9%) and PHOENIX 2 (47.0%) achieved marked responses at week 12, compared with placebo-treated patients (p<0.001 each). At week 28, approximately 50% of ustekinumab-treated patients achieved marked responses. Conclusion Significant proportions of ustekinumab-treated patients with moderate to severe psoriasis achieved marked clinical responses through week 28. Ustekinumab had a favorable risk-benefit profile through up to 18 months of follow-up.