p;
ENBREL®/ENBREL®
Placebo/ENBREL® 25 mg BIW 25 mg QW 25 mg BIW 50 mg BIW
(N = 168) (N = 169) (N = 167) (N = 168)
3 Months
PASI 75 n (%) 6 (4%) 23 (14%)* 53 (32%)† 79 (47%)†
Difference (95% CI) 10% (4, 16) 28% (21, 36) 43% (35, 52)
sPGA, “clear” or “minimal” n (%) 8 (5%) 36 (21%)† 53 (32%)† 79 (47%)†
Difference (95% CI) 17% (10, 24) 27% (19, 35) 42% (34, 50)
PASI 50 n (%) 24 (14%) 62 (37%)† 90 (54%)† 119 (71%)†
Difference (95% CI) 22% (13, 31) 40% (30, 49) 57% (48, 65)
6 Months
PASI 75 n (%) 55 (33%) 36 (21%) 68 (41%) 90 (54%)
Table 9: Study II Outcomes at 3 Months *
p < 0.0001 compared with placebo.
ENBREL®
Placebo 25 mg BIW 50 mg BIW
(N = 204) (N = 204) (N = 203)
PASI 75 n (%) 6 (3%) 66 (32%)* 94 (46%)*
Difference (95% CI) 29% (23, 36) 43% (36, 51)
sPGA “clear” or “minimal” n (%) 7 (3%) 75 (37%)* 109 (54%)*
Difference (95% CI) 34% (26, 41) 50% (43, 58)
PASI 50 n (%) 18 (9%) 124 (61%)* 147 (72%)*
Difference (95% CI) 52% (44, 60) 64% (56, 71)
Among PASI 75 achievers in both studies, the median time to PASI 50 and PASI 75 was approximately 1 and approximately 2 months, respectively, after the start of therapy with either 25 or 50 mg twice a week.
In Study I patients who achieved PASI 75 at month 6 were entered into a study drug withdrawal and retreatment period. Following withdrawal of study drug, these patients had a median duration of PASI 75 of between 1 and 2 months.
In Study I, in patients who were PASI 75 responders at 3 months, retreatment with open-label ENBREL® after discontinuation of up to 5 months resulted in a similar proportion of responders as was seen during the initial double-blind portion of the study.
In Study II, most patients initially randomized to 50 mg twice a week continued in the study after month 3 and had their ENBREL® dose decreased to 25 mg twice a week. Of the 91 patients who were PASI 75 responders at month 3, 70 (77%) maintained their PASI 75 response at month 6.
INDICATIONS AND USAGE
ENBREL® is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL® can be initiated in combination with methotrexate (MTX) or used alone.
ENBREL® is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.
ENBREL® is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL® can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
ENBREL® is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
ENBREL® is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
CONTRAINDICATIONS
ENBREL® should not be administered to patients with sepsis or with known hypersensitivity to ENBREL® or any of its components.
WARNINGS
Risk of Serious Infections
(see also Bo |
