Stelara 3 new studies

[Fred]

Here are three new studies published in The British Journal of Dermatology about Stelara (ustekinumab)

#1 #1

#2 #2

#3 #3

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[Fred]

Objectives:
The TRANSIT study aimed to assess the efficacy and safety of two methotrexate-to-ustekinumab transition strategies.

Methods:
Patients with moderate-to-severe psoriasis and inadequate methotrexate response were randomized 1:1 to initiate ustekinumab with immediate (arm 1) or 4-week gradual (arm 2) methotrexate withdrawal. Patients weighing ≤100 kg or >100 kg received 45 mg or 90 mg ustekinumab, respectively. The primary endpoint was the frequency of adverse events (AEs) at week 12. Secondary endpoints included additional safety, efficacy and patient-reported outcomes. We report the 12-week efficacy and safety results.

Results:
Overall, 244 patients in arm 1 and 245 in arm 2 were randomized and received ustekinumab. Four patients per arm discontinued the trial by week 12. At week 12 in arms 1 and 2, respectively, 61% and 65% of patients experienced an AE, 2.9% and 2.4% had a serious AE, and 1.2% and 0.4% had an AE leading to ustekinumab discontinuation. In arms 1 and 2, respectively: median psoriasis area and severity index (PASI) decreased from 15.2 and 15.4 at baseline to 2.9 and 2.8 at week 12; 58% and 62% of patients had PASI 75 at week 12; median baseline dermatology life quality index fell from 8 and 9 at baseline to 1 (both groups) at week 16.

Conclusions:
Ustekinumab was well tolerated and effective in patients inadequately responsive to methotrexate. Both transition strategies resulted in similar week 12 safety and efficacy outcomes.

[Fred]

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.

[Fred]

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.