Treatment: Biologics
Golimumab

FDA approved to treat:

• Psoriatic arthritis

• Patient must be 18 years of age or older and have active, moderate to severe psoriatic arthritis

• Also approved by the U.S. Food and Drug Administration (FDA) for treating two other diseases that affect the joints — active, moderate to severe rheumatoid arthritis and ankylosing spondylitis

What’s involved in taking golimumab?

• Patients are taught to give themselves a monthly injection.

• This injection is given under the skin.

• Two devices available: 1) Prefilled syringe or 2) a new device called an auto-injector, which received the Ease-of-Use Commendation by the Arthritis Foundation. (Both devices come pre-filled with 50 milligrams of golimumab.)

• Golimumab may be taken alone or in combination with methotrexate, another medication approved for the treatment of psoriasis and psoriatic arthritis.

• Before golimumab is prescribed, the patient has screening tests for the hepatitis B virus and latent (not causing symptoms) tuberculosis (TB).

• Patients on golimumab therapy are closely monitored and receive regular follow-up exams.

How does golimumab work? Like all biologics, golimumab works on part of the immune system. Golimumab targets and neutralizes a protein called TNF-alpha, which is made by the white blood cells and stimulates the immune system. If the body makes too much TNF-alpha, the immune system overreacts and this can lead to conditions such as psoriatic arthritis and psoriasis. By targeting and neutralizing TNF-alpha, golimumab can reduce inflammation. This, in turn, can reduce the signs and symptoms of psoriatic arthritis.

How effective is golimumab? Golimumab was tested in one of the most comprehensive clinical trials ever conducted for a medication that targets TNF-alpha. Conducted at 18 sites in United States, 18 sites in Canada, and 22 sites in Europe, the Phase 3 trial studied 405 patients with active psoriatic arthritis. The Phase 3 clinical trial, which led to FDA approval, found that patients receiving golimumab had:

• Fewer tender and swollen joints. At the beginning of the trial, all patients had at least 3 swollen joints and 3 tender joints. By week 14, the patients had received 4 doses of either golimumab or a placebo (inactive ingredient). Of those treated with golimumab, almost half (48%) saw a 20% improvement in their psoriatic arthritis. Only a few (9%) of those receiving the placebo had a 20% improvement. Some patients saw even greater improvement. By week 24, nearly 20% had a 70% improvement.
   

• Improved physical functioning and quality of life. The patients who received golimumab for 24 weeks also had significantly less morning stiffness. They reported improvements in their physical functioning and quality of life.
   

• Less psoriasis. The patients in this trial also had plaque psoriasis. About half of the patients receiving golimumab had a 75% reduction in psoriasis.
   

• Nail improvement. In people who have psoriatic arthritis, the nails may pull away from the nail bed or develop pitting, ridges, or a yellowish-orange discoloration. The patients receiving golimumab had significantly less nail disease.

Safety and side effects. During the clinical trials, both the patients receiving golimumab and the patients receiving the placebo experienced side effects. The most common side effects were mild. These side effects included upper respiratory tract infection, nausea, redness at the injection site, flu, runny nose, fever, and cold sores.

Some serious side effects also occurred in both groups of patients. In the group receiving the placebo, there were serious infections, which included 2 cases of pneumonia and 1 case of cellulitis (an infection deep within the skin).

In the patients receiving golimumab, 3 cases of cancer occurred between the beginning of the study and week 24. There were 2 cases of basal cell carcinoma (the most common form of skin cancer) and 1 case of prostate cancer. All cancers occurred in the group receiving the 100-milligram dose of golimumab once every 4 weeks. Based on this finding, the FDA-approved dose for golimumab is 50 milligrams once every 4 weeks.

Some patients in both the placebo group and the golimumab group experienced side effects that caused them to stop participating in the clinical trial. These side effects included vertigo, headache, nausea and chills, and hepatitis. Some patients who received golimumab from the beginning of the trial stopped taking golimumab due to elevated creatinine levels (indicates possible kidney disease), mumps, and signs of nerve problems (numbness, tingling, and muscle weakness).

These side effects have been reported for other FDA-approved medications that target TNF-alpha. What makes golimumab unique is that it is the first medication of its type to show that it can effectively treat the inflammation, joint destruction, and joint pain that can occur with psoriatic arthritis. Studies continue to monitor the long-term safety and side effects of golimumab.

References:
Kavanaugh A, McInnes I, Mease P et al. “Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty-four-week efficacy and safety results of a randomized, placebo-controlled study.” Arthritis & Rheumatism April 2009; 60: 976-86.