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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 Proportion of patients (%) 0 Week Proportion of patients (%) Week A 100 80 60 40 20 C 100 80 60 40 20 0 2 4 8 12 16 20 24 28 32 36 40 0 2 4 8 12 16 20 24 28 32 36 40 0 0 2 4 8 12 16 20 24 28 32 36 40 0 2 4 8 12 16 20 24 28 32 36 40 Placebo Placebo→ustekinumab 45 mg Ustekinumab 45 mg B D Placebo→ustekinumab 90 mg Ustekinumab 90 mg Figure 3: Proportion of patients achieving clinical response from baseline through week 40 PASI 75 (A), physician’s global assessment of cleared or minimal (0 or 1; B), PASI 90 (C), and PASI 50 (D); all patients randomised at baseline. For week 28 PASI 50 non-responders, data at week 28 were carried forward to weeks 32, 36, and 40. Solid arrows indicate visits at which ustekinumab was administered to patients randomised to receive ustekinumab at baseline; broken arrows indicate visits at which ustekinumab was administered to those randomised to receive placebo at baseline and crossover to ustekinumab at week 12. More than 90% of patients in both ustekinumab groups achieved PASI 50 (table 2), and about half of patients in both ustekinumab groups achieved at least 90% improvement from baseline in PASI (PASI 90) at week 28 (table 2). These response rates were generally maintained through week 40 (figure 3), when long-term responders underwent randomised withdrawal. Patients randomised to placebo at baseline achieved similar response rates after crossover at week 12 (figure 3). Among patients re-randomised at week 40, maintenance of PASI 75 (ie, time to loss of PASI 75 response) was better in patients receiving maintenance therapy than in patients withdrawn from therapy through at least 1 year (p

Articles The general patterns of common adverse events seen during the placebo crossover and randomised withdrawal phases were much the same as those seen during the placebo-controlled phase, although absolute event rates differed across study phases consistent with different lengths of follow-up (table 3). No dose response was seen in the rates of adverse events, serious adverse events, or adverse events leading to study agent discontinuation. Patients receiving maintenance therapy did not experience higher adverse event rates than did patients receiving interrupted therapy in the randomised withdrawal phase (table 3). The most common serious adverse events observed in the placebo crossover and randomised withdrawal phases included infections (a patient with a viral syndrome in the 45 mg group and a diabetic patient with a foot ulcer and osteomyelitis in the 90 mg group in the placebo crossover phase, and a patient with gastroenteritis in the interrupted therapy group in the randomised withdrawal phase); malignancies (one patient each with prostate and thyroid cancer in the 45 mg group in the crossover phase and one patient with colon cancer in the interrupted therapy group in the withdrawal phase); and cardiovascular events (two patients with myocardial infarctions [one each in the 45 mg group and placebo to 90 mg crossover group] and another who experienced a stroke in the placebo to 45 mg crossover group, all in the crossover phase). Patterns and rates of adverse events were comparable among patients in the placebo crossover group (who did not undergo randomised withdrawal) and were similar before and after dose adjustment in patients who did not achieve PASI 75 at week 28 or 40 and switched to dosing every 8 weeks (data not shown), with one additional serious infection reported (appendicitis), and one patient each reporting lentigo maligna, breast cancer, and transitional cell carcinoma (in a patient who had a perioperative myocardial infarction post-nephrectomy). No cases of mycobacterial or salmonella infection were observed. The proportions of patients with abnormalities in haematology and chemistry laboratory measures, including liver and renal function tests, were low and generally comparable between the placebo and ustekinumab groups through week 12 and during randomised withdrawal (data not shown). Ustekinumab had no effect on glucose, haemoglobin A₁ c levels, 11 neutrophil counts, 19 or D-dimer levels (data not shown). A greater reduction in mean CRP levels during the placebo-controlled phase was seen in patients receiving ustekinumab than in individuals on placebo. Of the patients with an abnormal CRP at baseline (about 30% of patients overall), a higher proportion of ustekinumabtreated patients normalised their CRP at week 12 than did those on placebo (28 [36·4%] of 77 patients in the 45 mg group, 31 [40·8%] of 76 in the 90 mg group, and 17 [22·1%] of 77 in the placebo group). Antibodies to ustekinumab had developed in 38 (5·1%) of the Median percentage Median change A 100 80 60 40 20 0 40 44 48 52 56 60 64 68 72 76 40 44 48 52 56 60 64 68 72 76 C 4 0 –4 –8 –12 –16 Ustekinumab 45 mg Placebo Every 12 weeks Ustekinumab 45 mg Placebo Every 12 weeks 746 patients for whom data were available by week 76; these were predominantly low titre (

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