Health Boards
Tue-01-10-2013, 10:54 AM
Objectives:
We describe 52-week data from TRANSIT, which initiated ustekinumab by licensed regimen and investigated exploratory dose adjustment.
Methods:
Patients with moderate-to-severe psoriasis and inadequate methotrexate response initiated ustekinumab, with immediate or gradual methotrexate withdrawal. Outcomes were similar between treatment arms at week 12 (primary endpoint), so week 52 data are pooled. Patients weighing ≤100 kg or >100 kg initiated 45 mg or 90 mg ustekinumab, respectively. Patients weighing ≤100 kg without psoriasis area and severity index (PASI) 75 response at weeks 28 or 40 received a dose adjustment to 90 mg. The primary analysis used observed data.
Results:
Overall, 391 and 98 patients initiated ustekinumab 45 mg and 90 mg, respectively. Forty-four patients (9%) discontinued before week 52 (0.4% due to adverse events). At week 52 (in the overall population), 369 patients (83%) achieved PASI ≤5, and 341 patients (77%) achieved PASI 75; median PASI decreased to 1.8 from 15 at baseline. At weeks 28 and 40, 84 and 31 patients, respectively, did not achieve PASI 75 and received a dose adjustment; by week 52, 35/82 (43%) and 15/31 (48%) of these patients, respectively, achieved PASI 75 (two discontinued between weeks 28–40).
Conclusions:
Ustekinumab showed sustained 1-year efficacy and was well tolerated when initially administered according to label. Adjusting ustekinumab dose to 90 mg may result in clinically meaningful improvement in response in patients ≤100 kg with suboptimal initial response.
We describe 52-week data from TRANSIT, which initiated ustekinumab by licensed regimen and investigated exploratory dose adjustment.
Methods:
Patients with moderate-to-severe psoriasis and inadequate methotrexate response initiated ustekinumab, with immediate or gradual methotrexate withdrawal. Outcomes were similar between treatment arms at week 12 (primary endpoint), so week 52 data are pooled. Patients weighing ≤100 kg or >100 kg initiated 45 mg or 90 mg ustekinumab, respectively. Patients weighing ≤100 kg without psoriasis area and severity index (PASI) 75 response at weeks 28 or 40 received a dose adjustment to 90 mg. The primary analysis used observed data.
Results:
Overall, 391 and 98 patients initiated ustekinumab 45 mg and 90 mg, respectively. Forty-four patients (9%) discontinued before week 52 (0.4% due to adverse events). At week 52 (in the overall population), 369 patients (83%) achieved PASI ≤5, and 341 patients (77%) achieved PASI 75; median PASI decreased to 1.8 from 15 at baseline. At weeks 28 and 40, 84 and 31 patients, respectively, did not achieve PASI 75 and received a dose adjustment; by week 52, 35/82 (43%) and 15/31 (48%) of these patients, respectively, achieved PASI 75 (two discontinued between weeks 28–40).
Conclusions:
Ustekinumab showed sustained 1-year efficacy and was well tolerated when initially administered according to label. Adjusting ustekinumab dose to 90 mg may result in clinically meaningful improvement in response in patients ≤100 kg with suboptimal initial response.
