AbbVie GK, Eisai Co., Ltd., and its subsidiary EA Pharma Co., Ltd. announced the additional approval for a new dosing regimen of Humira Pre-filled Syringe 40 mg/0.8 ml for Subcutaneous Injection (generic name: adalimumab[recombinant], Humira), a fully human anti-TNF monoclonal antibody formulation, in patients with moderate or severe Crohn's disease who become less responsive to treatment with 40 mg every two weeks to double the dose to 80 mg every two weeks.

The usual adult dose of Humira for Crohn's disease is: initial dose of 160 mg of adalimumab (recombinant) given subcutaneously (SC) followed by 80 mg SC two weeks after the initial dose, then after four weeks of the initial dose. Thereafter, 40 mg SC is given every two weeks. However, some patients became less responsive during their course of treatment, necessitating therapy aimed at "longterm maintenance of remission" which is the goal of treatment for Crohn's disease.

Recently, a Japanese clinical study demonstrated the efficacy of an increased dose of 80 mg every two weeks in patients who become less responsive to the conventional dose. As a result, an additional approval was granted for a change in dosing regimen for these patients.

The Japanese Clinical Study on which the present approval was granted was conducted at 12 trial sites with 28 patients suffering from moderate or severe Crohn's disease who became less responsive to treatment with 40 mg every two weeks. This study was a 52-week open-label study to assess the efficacy and safety of Humira when increased to 80 mg every two weeks in which the primary efficacy evaluation was performed at week 8. When compared to before dose increase, the percentage of patients who experienced a decrease of 50 or greater in Crohn's Disease Activity Index (CDAI) score was 75.0% at week 8 of treatment, showing an immediate benefit following dose increase. The benefit was maintained for a long period with the percentage of patients with improved CDAI score being 71.4% at Week 24 and 57.1% at week 52 of treatment. As for the safety of the increased dose of Humira, the safety profile was comparable to dose observed for conventional treatment with Humira; the increased dose was also well tolerated.

In Japan, AbbVie is the marketing and manufacturing authorization holder for Humira. For the indications in the field of gastrointestinal disease (i.e., ulcerative colitis, Crohn's disease, and intestinal Bechet's disease), AbbVie and EA Pharma, a subsidiary of Eisai, are co-promoting Humira. Abbvie and Eisai are co-promoting Humira for the indications in the fields other than gastrointestinal disease (i.e., rheumatoid arthritis, plaque psoriasis, arthropathic psoriasis, ankylosing spondylitis, and juvenile idiopathic arthritis).

AbbVie, Eisai and EA Pharma will continue to promote and provide information on the proper use of Humira while making further contributions to improve the quality of life of patients.

Humira is a fully human anti-TNF-alpha monoclonal antibody which is approved for the following indications in Japan: "treatment of rheumatoid arthritis (including prevention of structural joint damage) and the following diseases that do not sufficiently respond to existing treatments: psoriasis vulgaris; arthropathic psoriasis; ankylosing spondylitis; polyarticular juvenile idiopathic arthritis; intestinal Behcet's disease; moderate to severe active Crohn's disease as remission induction and maintenance therapy; and moderate to severe ulcerative colitis."

Crohn's disease (CD) is an inflammatory disease characterized by ulcers and/or inflammatory lesions in the gastrointestinal tract and is associated with repeated flares/relapses over its long course; CD is most commonly seen in adolescents in their 10s to 20s. The number of CD patients in Japan is increasing every year, from 128 patients in 1976 to 29,799 in 2013.