This summary of a Cochrane review presents what we know from research about the effect of biologics on rheumatoid arthritis (RA).
The review shows that in people with rheumatoid arthritis;
- Golimumab improves the number of tender or swollen joints and other outcomes such as pain and disability (ACR 50).
- Golimumab increases the number of people in remission.
- Slightly more people who take Golimumab will have minor side effects (such as a minor infection), but this may be the result of chance. There is no difference in the number of people who will have a serious adverse event, compared to people who took a placebo.
We do not have precise information about side effects and complications. This is particularly true for rare but serious side effects. Possible side effects may include a serious infection or upper respiratory infection. Rare complications may include certain types of cancer.
What is rheumatoid arthritis (RA) and what are is golimumab?
When you have rheumatoid arthritis, your immune system, which normally fights infection, attacks the lining of your joints making them inflamed. This inflammation causes your joints to be hot, swollen, stiff, and painful. The small joints of your hands and feet are usually affected first. If the inflammation goes on without treatment, it can lead to damaged joints. Once the joint is damaged it cannot be repaired, so treating rheumatoid arthritis early is important.
Golimumab is an anti-tumor necrosis factor (TNF)-alpha biologic drug. Biologics are a group of medications that suppress the immune system and reduce the inflammation in the joints. Even though suppressing the immune system can make it slightly harder to fight off infections, it also helps to stabilize an overactive immune system. By reducing the inflammation, the aim is to help prevent damage to the joints. Golimumab is an injection given once a month.
Best estimate of what happens to people with rheumatoid arthritis who take golimumab:
ACR 50 (number of tender or swollen joints and other outcomes such as pain and disability)
- 23 more people out of 100 experienced improvement in the symptoms of their rheumatoid arthritis after 14-24 weeks with golimumab (23% absolute improvement).
- 38 people out of 100 who took golimumab experienced improvement.
- 15 people out of 100 who took a placebo experienced improvement.
- 18 more people out of 100 were considered to be in remission after 14-24 weeks with golimumab (18% absolute improvement).
- 22 people out of 100 were considered to be in remission with golimumab.
- 4 people out of 100 were considered to be in remission with placebo.
People who dropped out of the studies due to any reason
- 5 fewer people out of 100 who took golimumab dropped out of the studies for any reason. (2% absolute difference)
- 5 people out of 100 who took golimumab dropped out of the studies for any reason.
- 10 people out of 100 who used a placebo dropped out of the studies for any reason.
With an overall high grade of evidence, at the FDA-approved dose, golimumab is significantly more efficacious than placebo in treatment of patients with active RA , when used in combination with methotrexate. The short-term safety profile, based on short-term RCTs, is reasonable with no differences in total adverse events, serious infections, cancer, tuberculosis or deaths. Long-term surveillance studies are needed for safety assessment.
Golimumab is a humanized inhibitor of Tumor necrosis factor-alpha, recently approved by the Food and Drug Administration (FDA) for the treatment of Rheumatoid arthritis (RA).
The objective of this systematic review was to compare the efficacy and safety of golimumab (alone or in combination with DMARDs or biologics) to placebo (alone or in combination with DMARDs or biologics) in randomized or quasi-randomized clinical trials in adults with RA.
An expert librarian searched six databases for any clinical trials of golimumab in RA, including the Cochrane Central Register of Controlled Trials (CENTRAL), OVID MEDLINE, CINAHL, EMBASE, Science Citation Index (Web of Science) and Current Controlled Trials databases.
Studies were included if they used golimumab in adults with RA, were randomized or quasi-randomized and provided clinical outcomes.
Two review authors (JS, SN) independently reviewed all titles and abstracts, selected appropriate studies for full review and reviewed the full-text articles for the final selection of included studies. For each study, they independently abstracted study characteristics, safety and efficacy data and performed risk of bias assessment. Disagreements were resolved by consensus. For continuous measures, we calculated mean differences or standardized mean differences and for categorical measures, relative risks. 95% confidence intervals were calculated.
Four RCTs with 1,231 patients treated with golimumab and 483 patients treated with placebo were included. Of these, 436 were treated with the FDA-approved dose of golimumab 50 mg every four weeks. Compared to patients treated with placebo+methotrexate, patients treated with the FDA-approved dose of golimumab+methotrexate were 2.6 times more likely to reach ACR50 (95% confidence interval (CI) 1.3 to 4.9; P=0.005 and NNT= 5, 95% confidence interval 2 to 20), no more likely to have any adverse event (relative risk 1.1, 95% Cl 0.9 to 1.2; P=0.44), and 0.5 times as likely to have overall withdrawals (95% Cl 0.3 to 0.8; P=0.005). Golimumab-treated patients were significantly more likely to achieve remission, low disease activity and improvement in functional ability compared to placebo (all statistically significant). No significant differences were noted between golimumab and placebo regarding serious adverse events, infections, serious infections, lung infections, tuberculosis, cancer, withdrawals due to adverse events and inefficacy and deaths. No radiographic data were reported.