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Articles Efficacy and safety of ustekinumab, a human ... - Huidarts.com

Articles Efficacy and safety of ustekinumab, a human ... - Huidarts.com

Articles Screen Placebo-controlled phase Placebo crossover and active treatment phase Randomised withdrawal phase R Placebo → Retreatment Group 1 Ustekinumab 45 mg at weeks 0, 4 → every 12 weeks 45 mg every 12 weeks R R Placebo → Retreatment Group 2 Ustekinumab 90 mg at weeks 0, 4 → every 12 weeks 90 mg every 12 weeks 3a Group 3 Placebo at weeks 0, 4 3b Ustekinumab 45 mg at weeks 12, 16 → every 12 weeks Ustekinumab 90 mg at weeks 12, 16 → every 12 weeks Week 28:* PASI

Articles placebo-crossover and active treatment phase (weeks 12–40), and a randomised withdrawal phase (weeks 40–76; figure 1). At baseline, patients were randomly assigned in equal proportions to receive subcutaneous injections of ustekinumab 45 or 90 mg at weeks 0 and 4 and every 12 weeks thereafter or placebo at weeks 0 and 4, with half randomised to crossover to ustekinumab 45 mg and half to ustekinumab 90 mg at week 12 (figure 1). At week 40, patients who had initially been randomised to receive ustekinumab who achieved long-term response (at least 75% improvement from baseline in PASI score [PASI 75] at weeks 28 and 40) were re-randomised to continue maintenance treatment with ustekinumab or were withdrawn from active treatment (placebo). Patients withdrawn from treatment at week 40 were retreated when they lost at least 50% of PASI improvement. Patients not achieving PASI 75 at week 28 or 40 were not re-randomised, and their dosing was discontinued or modified (figure 1). Patients received placebo injections as needed to preserve the blind. The study sponsor was unblinded to treatment assignments at week 52 for analysis purposes. Site monitors, investigators, site personnel involved in study conduct, and patients remained blinded until week 76. Patients were allocated to treatment groups at weeks 0 and 40 with a minimisation method with biased coin assignment 14 via a centralised interactive voice response 984 screened 766 randomised 255 ustekinumab 45 mg every 12 weeks regimen 256 ustekinumab 90 mg every 12 weeks regimen 255 placebo 1 discontinued study agent 0 lack of efficacy 0 adverse event 1 other 1 received no treatment 10 discontinued study agent 1 lack of efficacy 2 adverse event 7 other 12 discontinued study agent 3 lack of efficacy 6 adverse event 3 other Placebo crossover (week 12) 123 crossed over to 45 mg ustekinumab every 12 weeks regimen 120 crossed over to 90 mg ustekinumab every 12 weeks regimen 38 discontinued study agent* 19 lack of efficacy 11 adverse event 8 other 66 adjusted to every 8 weeks dosing and completed study agent through week 76 19 discontinued study agent* 6 lack of efficacy 7 adverse event 6 other 54 adjusted to every 8 weeks dosing and completed study agent through week 76 11 discontinued study agent* 7 lack of efficacy 2 adverse event 2 other 44 adjusted to every 8 weeks dosing and completed study agent through week 76 5 discontinued study agent* 2 lack of efficacy 1 adverse event 2 other 23 adjusted to every 8 weeks dosing and completed study agent through week 76 Randomised withdrawal (week 40) 73 randomised to placebo → retreatment 77 randomised to 45 mg every 12 weeks 87 randomised to placebo → retreatment 85 randomised to 90 mg every 12 weeks 68 switched to placebo → retreatment 92 switched to placebo → retreatment 4 discontinued study agent 0 lack of efficacy 2 adverse event 2 other 0 discontinued study agent 0 lack of efficacy 0 adverse event 0 other 2 discontinued study agent 0 lack of efficacy 1 adverse event 1 other 1 received no treatment 4 discontinued study agent 0 lack of efficacy 3 adverse event 1 other 1 discontinued study agent 0 lack of efficacy 1 adverse event 0 other 1 received no treatment 2 discontinued study agent 1 lack of efficacy 0 adverse event 1 other 69 completed study agent through week 76 77 completed study agent through week 76 85 completed study agent through week 76 80 completed study agent through week 76 67 completed study agent through week 76 89 completed study agent through week 76 Figure 2: Trial profile *Includes patients who were adjusted to dosing every 8 weeks and discontinued treatment after week 40. www.thelancet.com Vol 371 May 17, 2008 1667

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