FDA approved to treat:
Patient must be 18 years of
age or older and have active, moderate to severe psoriatic
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
Patients are taught to give
themselves a monthly injection.
This injection is given under
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.
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
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.
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;
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developed by the American Academy of Dermatology