The FDA has approved golimumab (Simponi Aria, Janssen Biotech, Inc.) for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS).
Golimumab is a fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion. It first received FDA approval in 2013 for the treatment of moderately to severely active rheumatoid arthritis (RA).
The approvals of golimumab for PsA and AS are based on two large-scale, pivotal phase 3 studies involving more than 600 patients. In both studies, the primary endpoints were met, with a higher proportion of patients demonstrating significant improvement in the signs and symptoms of PsA and AS in the groups receiving treatment with golimumab compared with those receiving placebo.
In the GO-VIBRANT (PsA) study, 75% of patients receiving golimumab, compared with 22% of patients receiving placebo (P < 0.001), achieved at least a 20% improvement in the American College of Rheumatology (ACR20) response at week 14. Treatment with golimumab resulted in the inhibition of the progression of structural joint damage and improvement in physical function associated with PsA at week 24.
In the GO-ALIVE (AS) study, 73% of patients receiving golimumab, compared with 26% of patients receiving placebo (P < 0.001), achieved at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at week 16. ACR20 and ASAS20 are standard measures used to assess clinical improvement in PsA and AS, respectively.
PsA is a chronic, immune-mediated inflammatory disease characterized by both joint inflammation and the skin lesions associated with psoriasis. It is estimated that at least one million Americans are living with PsA, and up to 30% of patients living with psoriasis can develop PsA. The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any time. Though the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.
AS is a chronic, immune-mediated disease of the axial skeleton, affecting the sacroiliac joints and the spine. AS frequently also causes enthesitis, which is inflammation where ligaments and muscles attach to bones, most commonly those within the spine. It is the primary disease in a group of arthritis-related diseases known as spondyloarthritis. It is estimated that 700,000 people in the U.S. are living with AS. Peripheral joint involvement (in particular, hips and shoulders) can occur. Other organs can also be involved, including the eyes (uveitis), heart and aorta, and lungs. The disease affects men more often than women and typically manifests in early adulthood. In contrast to mechanical low back pain, low back pain and stiffness with AS worsen after a period of rest or upon waking up in the morning and improve after exercise, a hot bath, or a shower.
Golimumab is a human anti-TNF-alpha monoclonal antibody that targets both soluble and transmembrane bioactive forms of human TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation. By binding with and blocking TNF-alpha, golimumab helps control inflammation.
Source: Janssen Biotech, Inc.; October 20, 2017.