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Assess ustekinumab efficacy (week 24/week 52) and safety (week 16/week 24/week 60) in patients with active psoriatic arthritis (PsA) despite treatment with conventional and/or biological anti-tumour necrosis factor (TNF) agents.
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Following the 12-week efficacy phase (weeks 13 24), participants in the placebo group were randomized equally to receive alogliptin 12.5 or 25.0 mg daily in addition to metformin and continue treatment for an additional 40 weeks in an open-label extension period.
The study also assessed the sustainability of programme efficacy at week 36.
This resulted in equivalent efficacy at week 52 (Fig. 1 A ).
When expanding the analysis to additional markers, signs for efficacy beyond week 12 could be reported.
However, there was no statistically significant difference between the two arms in clinical efficacy at week 48.
Patients who discontinued study treatment due to lack of efficacy before week 12 were considered as non-responders.
The roadmap concept assesses antiviral efficacy at Week 24 to make treatment adjustments based on the decline in HBV DNA levels.
The study drug will be discontinued if it shows unsatisfactory efficacy at week 12 (i.e., FPG >13.3 mmol/L [240 mg/dL]) confirmed by a repeated measurement in the absence of any concurrent illness.
Long-term efficacy: At weeks, 24 and 36, 41.3 and 37.3% of patients were abstinent, with no statistically significant differences between treatments.
The efficacy during weeks 3 to 54 was only 26%.
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