This article is part of the Arthritis Archives.
Editor note: Humira (adalimumab) was approved by the United States Food and Drug Administration on December 31, 2002
Dateline: June 24, 2002
Humira (Adalimumab) Highly Anticipated By Rheumatoid Arthritis Patients
In April, 2002, Abbott Laboratories' filed for the regulatory approval of Humira (also known as D2E7 or adalimumab) from the U.S. Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products (EMEA).
Anti-TNF drugs are injectable biologic drugs designed to block TNF (tumor necrosis factor), a protein involved in the inflammatory process. Humira is a monoclonal antibody made completely from human protein, unlike Enbrel (etanercept) which is man-made, and Remicade (infliximab) which is made partly with mouse protein. The fully human aspect of Humira (adalimumab) is expected to lessen the side effects.
Results From Phase III STAR Trial
The Phase III STAR Trial (Safety Trial of Adalimumab in Rheumatoid Arthritis), reportedly one of the largest, controlled safety studies in rheumatoid Arthritis revealed that after 24 weeks of therapy:
- There were no statistically significant differences in rates of adverse events, serious adverse events, infections, or serious infections, between D2E7 and placebo when combined with the patients' pre-existing anti-rheumatic therapy.
- The STAR Trial included 636 patients.
- The trial was designed to assess safety as the primary endpoint.
- The protocol was designed to represent common clinical practices by allowing physicians to continue prescribing a combination of DMARDS. Trial participants were taking up to 4 DMARDS.
- Patients were randomized to receive either subcutaneous injections of placebo or 40 mg. of D2E7, every other week.
- Injection site reactions, rash, and back pain, were the only adverse events which differed significantly between Humira and placebo.
- ACR criteria was used to measure the effectiveness of Humira. ACR20, ACR50, and ACR70 represent the percentage of improvement (20%, 50%, and 70%) in tender and swollen joint counts as well as other clinical measures.
Percent improvement in symptoms (ACR20, ACR50, ACR70) for patients on D2E7 was 55, 30, and 15 respectively. For patients on placebo, it was 36, 11, and 3 percent respectively.
Ongoing Results From Phase II ARMADA Trial
Also reported at EULAR were ongoing results from another trial, the Phase II ARMADA Trial (Anti-TNF Research Study Program of the Monoclonal Antibody D2E7 in Patients with Rheumatoid Arthritis.) One year results from this study indicated that 241 of 271 patients (89%) who began the trial chose to remain on Humira in combination with methotrexate for over a year. After 12 months of the combined therapy, 25.3% achieved the ACR70 response, while 70% achieved the ACR20 response and 48% achieved ACR50 response.
It has been predicted that the anticipated approval of Humira adalimumab) will generate $1 billion in peak annual sales within 4 to 5 years after product launch. Potentially lower risk of side effects and a convenient dosing schedule have Abbott's adalimumab set to take on its competitors. For now, Abbott is awaiting approval and awaiting the chance to offer rheumatoid arthritis patients a promising new drug.
- Humira (adalimumab)
- TNF Blockers / Biologic DMARDs
- TNF Blockers (Enbrel, Remicade, Humira) - Test Your Knowledge
- Rheumatoid Arthritis
Sources: First Phase III Data for Abbott Laboratories' D2E7 (Adalimumab) Support Promise in RA, Press Release 6/14/02; Abbott Says Data Confirms Arthritis Drug Promise, Reuters, 6/14/02
Phase II ARMADA Trial (Anti-TNF Research Study Program of the Monoclonal Antibody D2E7 in Patients with Rheumatoid Arthritis; ; EULAR 2002
2.5-YEAR TREATMENT RESULTS WITH ADALIMUMAB (D2E7), THE FIRST FULLY HUMAN ANTI-TNF MONOCLONAL ANTIBODY, IN COMBINATION WITH METHOTREXATE IN ACTIVE RHEUMATOID ARTHRITIS; ; EULAR 2002
First published: 6/24/2002