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AbbVie, a research-based global biopharmaceutical company and Eisai Co., Ltd. announced that they have received approval for an additional indication of HUMIRA (generic name: adalimumab [recombinant], “HUMIRA”), a fully human anti-TNF-alpha monoclonal antibody, for the treatment of hidradenitis suppurativa (HS). With this approval, HUMIRA has become the first treatment indicated for HS in Japan, and is now approved for 11 indications in Japan.
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The approval of this additional indication is based on the data from a Japanese Phase III study(1) and overseas clinical trials.(2) In these trials, the efficacy and safety of HUMIRA were evaluated in patients with moderate to severe HS. In the clinical trial conducted in Japan, the percentage of patients who achieved the primary endpoint of HiSCR* at Week 12 after treatment was 13 of 15 patients.3 In the same trial, adverse drug reactions (ADRs) were observed in 6 of 15 patients at Week 24 of treatment; ADRs observed in two or more patients were nasopharyngitis and cellulitis, and other ADRs including dental caries, erythrasma, folliculitis, lymphocyte count increased, erythema, pruritus, and skin exfoliation were observed in one patient each.(3)
HS is a painful, inflammatory skin disease with a chronic course which typically presents after puberty. Inflammatory symptoms are frequently observed in the axillary, inguinal, breast-fold, and gluteal regions. The main symptom is red, swollen boil-like lumps, and the progression of symptoms leads to formation of nodules, abscesses, and even fistulas. Repeated recurrence causes thickening of the affected areas, resulting in scarring.(4) Severe symptoms may limit the patients’ daily activities and sometimes force them to stop working.(5) The epidemiology data in Japan is unknown,(6) and the prevalence outside Japan is reported to be 1%.(7) Since the disease is poorly recognized and difficult to diagnose, overseas reports indicate that the average time to definitive diagnosis is seven years, which is longer than that of psoriasis and other inflammatory skin diseases, and patients with HS visit hospitals more often.
“This approval will be a major step for patients with HS. HS is a recurrent disease with pain and pus discharge. It has a significant impact on patients’ quality of life, affecting their work or study performance and, in advanced cases, requiring major surgery with skin grafting,” said Dr. Tadashi Terui, Professor, Division of Cutaneous Science, Department of Dermatology, Nihon University School of Medicine. “Only limited options have been available for the treatment of HS until now. The additional indication of HUMIRA for HS is expected to significantly contribute to the improvement in patients’ quality of life.”
AbbVie and Eisai 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.
* HiSCR stands for Hidradenitis Suppurativa Clinical Response, and is defined as at least a 50% reduction from baseline in the abscess and inflammatory nodule counts, with no increase in abscess or draining-fistula counts.
(1) ClinicalTrials.gov Identifier: NCT02904902
(2) ClinicalTrials.gov Identifier: NCT01468207, NCT01468233
(3) Annual Meeting of the Tokyo Division of JDA, 2nd December, 2018
(4) Hunger RE, et al. Dermatology. 2017 Jul 7. doi: 10.1159/000477459.
(5) Jemec G. Clinical and experimental dermatology. , 1996, Vol.21(6), p.419-423
(6) Nobukazu Hayashi et.al., Journal of the Japan Organization of Clinical Dermatologists, 35 (4) ;601-609, 2018
(7) Revuz J., J Eur Acad Dermatol Venereol. 2009 Sep;23(9):985-98.
About HUMIRA
HUMIRA is a fully human anti-TNF-alpha; monoclonal antibody formulation. In Japan, it is approved for the indications of “the treatment of rheumatoid arthritis (including inhibition of the progression of structural damage), the treatment of plaque psoriasis, arthritic psoriasis, pustular psoriasis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis,** intestinal Behcet’s disease, non-infectious uveitis, posterior uveitis or panuveitis, induction and maintenance therapy for moderate to severely active Crohn’s disease (administer HUMIRA to patients who have had an inadequate response to conventional therapy), and treatment of moderate to severe ulcerative colitis (administer HUMIRA to patients who have had an inadequate response to conventional therapy).”
** HUMIRA for Subcutaneous Injection 80 mg Syringe 0.8 mL and HUMIRA for Subcutaneous Injection 80 mg Pen 0.8 mL are yet to be approved for this indication.
Only HUMIRA for Subcutaneous Injection 20 mg Syringe 0.4 mL and HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL are approved for this indication.
Source: ACN Newswire