Health Boards
Tue-01-10-2013, 10:57 AM
Objectives:
To assess improvement in fingernail psoriasis with ustekinumab treatment in PHOENIX 1.
Methods:
Patients received ustekinumab 45 mg or 90 mg or placebo at weeks 0 and 4. Ustekinumab-randomized patients continued maintenance dosing every 12 weeks, while placebo patients crossed over to receive ustekinumab 45 mg or 90 mg at weeks 12/16 followed by every 12 week dosing. At week 40, Initial Responders (those with ≥75% improvement from baseline in Psoriasis Area and Severity Index score [PASI 75]) were re-randomized to either continue maintenance dosing or withdraw from treatment. Nail involvement was evaluated using the Nail Psoriasis Severity Index (NAPSI) on a target fingernail, Nail Physician's Global Assessment (Nail PGA), and mean number of nails involved.
Results:
Of 766 randomized patients, 545 (71.1%) had nail psoriasis. At week 24, the percent improvement from baseline NAPSI score was 46.5% [ustekinumab 45 mg] and 48.7% [ustekinumab 90 mg]. Percent improvements in NAPSI ranged from 29.7% (PASI 50) to 57.3% (PASI 90). Mean NAPSI scores improved from 4.5 at baseline to 2.4 at week 24 (45 mg) and from 4.4 to 2.2 (90 mg). Nail PGA scores and mean number of psoriatic nails improved by week 24. Further improvement was observed for all endpoints among Initial Responders continuing maintenance treatment through week 52.
Conclusions:
Ustekinumab significantly improves nail psoriasis, and improvements continue over time through up to one year of treatment in those receiving maintenance treatment.
To assess improvement in fingernail psoriasis with ustekinumab treatment in PHOENIX 1.
Methods:
Patients received ustekinumab 45 mg or 90 mg or placebo at weeks 0 and 4. Ustekinumab-randomized patients continued maintenance dosing every 12 weeks, while placebo patients crossed over to receive ustekinumab 45 mg or 90 mg at weeks 12/16 followed by every 12 week dosing. At week 40, Initial Responders (those with ≥75% improvement from baseline in Psoriasis Area and Severity Index score [PASI 75]) were re-randomized to either continue maintenance dosing or withdraw from treatment. Nail involvement was evaluated using the Nail Psoriasis Severity Index (NAPSI) on a target fingernail, Nail Physician's Global Assessment (Nail PGA), and mean number of nails involved.
Results:
Of 766 randomized patients, 545 (71.1%) had nail psoriasis. At week 24, the percent improvement from baseline NAPSI score was 46.5% [ustekinumab 45 mg] and 48.7% [ustekinumab 90 mg]. Percent improvements in NAPSI ranged from 29.7% (PASI 50) to 57.3% (PASI 90). Mean NAPSI scores improved from 4.5 at baseline to 2.4 at week 24 (45 mg) and from 4.4 to 2.2 (90 mg). Nail PGA scores and mean number of psoriatic nails improved by week 24. Further improvement was observed for all endpoints among Initial Responders continuing maintenance treatment through week 52.
Conclusions:
Ustekinumab significantly improves nail psoriasis, and improvements continue over time through up to one year of treatment in those receiving maintenance treatment.
