ery other week Placebo
N = 814 N = 398
PGA: Clear or minimal* 506 (62%) 17 (4%)
PASI 75 578 (71%) 26 (7%)
* Clear = no plaque elevation, no scale, plus or minus hyperpigmentation or diffuse pink or red coloration
Minimal = possible but difficult to ascertain whether there is slight elevation of plaque above normal skin, plus or minus surface dryness with some white coloration, plus or minus up to red coloration
Table 15. Efficacy Results at 16 Weeks in Study Ps-II Number of Patients (%) Humira 40 mg every other week Placebo
N = 99 N = 48
PGA: Clear or minimal* 70 (71%) 5 (10%)
PASI 75 77 (78%) 9 (19%)
* Clear = no plaque elevation, no scale, plus or minus hyperpigmentation or diffuse pink or red coloration
Minimal = possible but difficult to ascertain whether there is slight elevation of plaque above normal skin, plus or minus surface dryness with some white coloration, plus or minus up to red coloration
Additionally, in Study Ps-I, subjects on Humira who maintained a PASI 75 were re-randomized to Humira (N = 250) or placebo (N = 240) at Week 33. After 52 weeks of treatment with Humira, more patients on Humira maintained efficacy when compared to subjects who were re-randomized to placebo based on maintenance of PGA of “clear” or “minimal” disease (68% vs. 28%) or a PASI 75 (79% vs. 43%).
A total of 347 stable responders participated in a withdrawal and retreatment eva luation in an open-label extension study. Median time to relapse (decline to PGA “moderate” or worse) was approximately 5 months. During the withdrawal period, no subject experienced transformation to either pustular or erythrodermic psoriasis. A total of 178 subjects who relapsed re-initiated treatment with 80 mg of Humira, then 40 mg eow beginning at week 1. At week 16, 69% (123/178) of subjects had a response of PGA “clear” or “minimal”.
REFERENCES
1.National Cancer Institute. Surveillance, Epidemiology, and End Results Database (SEER) Program. SEER Incidence Crude Rates, 11 Registries, 1993-2001.
How Supplied/Storage and Handling
Humira® (adalimumab) is supplied as a preservative-free, sterile solution for subcutaneous administration. The following packaging configurations are available.
•Humira Pen Carton
Humira is dispensed in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-use pen, containing a 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of Humira. The NDC number is 0074-4339-02.
•Humira Pen – Crohn's Disease/Ulcerative Colitis Starter Package
Humira is dispensed in a carton containing 6 alcohol preps and 6 dose trays (Crohn’s Disease/Ulcerative Colitis Starter Package). Each dose tray consists of a single-use pen, containing a 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of Humira. The NDC number is 0074-4339-06.
•Humira Pen – Psoriasis Starter Package
Humira is dispensed in a carton containing 4 alcohol preps and 4 dose trays (Psoriasis Starter Package). Each dose tray consists of a single-use pen, containing a 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of Humira. The NDC number is 0074-4339-07.
•Prefilled Syringe Carton – 40 mg
Humira is dispensed in a carton containing two alcohol preps and two dose t |
