AbbVie and Eisai announced the additional approval for a new indication of Humira, a fully human anti-TNF-alpha monoclonal antibody formulation, in the treatment of patients who have had an inadequate response to conventional therapy for pustular psoriasis. With this approval, Humira has been approved for 10 indications in Japan.
The approval of this additional indication is based on the results of a Phase III study in Japanese patients. This study examined efficacy and safety in Japanese patients diagnosed with generalised pustular psoriasis (GPP) who have had an inadequate response to conventional therapy (eg, etretinate and cyclosporine).
Among the patients treated with Humira in the open-label clinical trial, 70% achieved a clinical response (improvement or reduction of skin score relative to the baseline) after 16 weeks of treatment.
Adverse reactions were observed in 30% of patients, such as eosinophilia, bacterial colitis, herpes zoster infection and eye contusion, respective incidence was 10%. No new safety risks were identified for patients with GPP treated with HUMIRA.
Pustular psoriasis is a disease designated as an "Intractable Disease" by the Japan Ministry of Health, Labor and Welfare (MHLW) and the major symptoms include fever, general malaise, redness, swelling of limbs, and pustules on the whole body.
The number of patients receiving intractable disease benefits due to this condition is reported to be 2072 nationwide and this has increased by more than 200 patients in the past 5 years (as of the end of fiscal 2016).
The treatment guideline for pustular psoriasis includes anti-TNF-alpha antibody formulations as a treatment option alongside etretinate, methotrexate and cyclosporine.
"The research and clinical technology on GPP have been evolving dramatically in the recent years. However, further progress is needed considering severity of the disease. The approval of this indication for HUMIRA has been highly anticipated by healthcare professionals as well as patients," said Dr Hidemi Nakagawa, Chair, Department of Dermatology, The Jikei University School of Medicine.
"We are pleased to provide the new treatment option to patients with pustular psoriasis," said James Feliciano, President of AbbVie Japan.
"More than 1 million patients have been already treated with HUMIRA in more than 100 countries. This is the 10th indication of HUMIRA approved on the 10th anniversary of its first launch in Japan. We continue to contribute to patients living with inflammatory autoimmune diseases by pursuing new discoveries and better outcomes that go beyond current standards of care."
Hideki Hayashi, Eisai Representative Corporate Officer, Japan Business and CIO, said: "Eisai will continue to provide healthcare professionals with information and promote proper clinical use, aiming to fulfill the unmet medical needs in the treatment of GPP and maximise benefits for patients and their families."