New drug increases options for arthritis patients

Drugs that suppress the immune system have been a major breakthrough in the treatment of rheumatoid arthritis. Unfortunately, these drugs don't work for everyone, and not all patients can put up with the side effects. A new drug, called golimumab, has now been shown by researchers to help people who haven't benefited from other medicines.

What do we know already?

Rheumatoid arthritis is a painful condition that affects your joints. It happens when your immune system malfunctions and attacks healthy tissue in your joints, making them swollen and painful.

There are lots of treatments for people with rheumatoid arthritis, but often a drug that helps one person won't work for someone else. Doctors often suggest ibuprofen and similar drugs to help with pain and swelling. However, these drugs don't prevent further damage to the joints.

Drugs that do protect the joints are called disease-modifying drugs. A common one is called methotrexate. Steroids can also be used to reduce pain and protect your joints.

Several new arthritis drugs have been launched in recent years, increasing the options for people who haven't found a combination of treatments that suits them. The newest drugs alter the way someone's immune system works, making it less able to damage the joints. Drugs that do this are called biologics.

A new biologic, called golimumab, was launched in the United States in April this year. Last week, the committee that checks the safety of drugs in Europe recommended that golimumab be made available on the European market, although it's too soon to say when it will be launched in Britain.

Golimumab is given as a monthly injection, and intended for use alongside methotrexate. It belongs to a class of drugs called TNF inhibitors. A new study has looked at how effective golimumab is when other drugs have failed.

What does the new study say?

The study looked at 461 people, all of whom had given up on a previous TNF inhibitor, either because it hadn't worked or caused side effects. People were given a high or low dose of golimumab, or an inactive placebo. All patients continued with their other medicines, which usually meant methotrexate.

Everyone's symptoms were given a score. After 14 weeks, the researchers looked at whether people's scores had improved by at least 20 percent. Thirty-eight percent of people who took the higher dose of golimumab had improved, compared with 35 percent of people who took the lower dose, and only 18 percent of people who took a placebo.

The study didn't find many side effects, but golimumab works by suppressing your immune system, so it can potentially cause serious problems. The US drug regulator says possible side effects include dangerous infections, heart failure and a type of cancer called lymphoma, although these are likely to be rare. The most common side effects are cold and flu symptoms, and irritation at the spot where you have the injection.

How reliable are the findings?

The study was carefully done, but only lasted 24 weeks. So, we don't know how well golimumab works over the long term, or whether it has long-term side effects. That's an important issue, as we already know that similar drugs carry serious risks.

Another weakness is that the study compared golimumab to a placebo, and not another TNF inhibitor. There are several drugs in this class now, so it would be useful for doctors to know how they compare to each other. It can also be unfair to patients in the study if they're given a placebo when we already know there are already effective drugs available. In this case, patients in the placebo group were given "rescue" medication after the study ended.

Where does the study come from?

The study was done by researchers from several countries, including Austria, the Netherlands, and the United States. It appeared in The Lancet, a medical journal published by a company called Elsevier.

The study was funded by Centocor and Schering-Plough, the companies that market golimumab.
What does this mean for me?

Golimumab isn't available in the UK yet. The committee that advises the European drug regulator has recommended that the drug be licensed throughout Europe, which would allow it to be used in the UK. Assuming the drug gets a licence, it would also need approval from NICE before it became a standard NHS treatment.

Several other TNF inhibitors are already in use in the UK. They're called etanercept (brand name Enbrel) infliximab (Remicade) and adalimumab (Humira). They only tend to be used if other drugs haven't helped.

What should I do now?

If you have rheumatoid arthritis and your treatment isn't helping, make an appointment to see your doctor. He or she can help you find a drug or combination of drugs that works for you.

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