In newly diagnosed people undergoing rapid glucocorticoid tapering, tocilizumab was superior to placebo
INTRODUCTION
Polymyalgia rheumatica (shortened to PMR) is the second most common inflammatory rheumatic disease in people over the age of 50. Symptoms include pain in the neck, shoulders, and hips, as well as morning stiffness. PMR can be treated with glucocorticoids (also called steroids). Many people respond quickly to these medicines, but there are side effects linked to long-term use of steroids, so doctors often try to reduce the dose and gradually get people back off treatment (often called tapering). However, around half of people have a relapse when trying to come off or reduce their steroid dose. Since PMR is an inflammatory disease, it might be possible to reduce the amount of steroids people need to take by using different types of medicines instead. Tocilizumab is one of a group of medicines called a biologic disease-modifying antirheumatic drug (sometimes also referred to as a bDMARD). It works by targeting one of the molecules involved in the underlying inflammation.
WHAT DID THE AUTHORS HOPE TO FIND?
The authors hoped to prove that tocilizumab works to treat people with newly diagnosed PMR. They wanted to show that this treatment might be a new option to help reduce the use of steroids.
WHO WAS STUDIED?
The study looked at 36 people with PMR. Everyone taking part had been diagnosed with PMR within the last 2 weeks. This is referred to as new-onset disease.
HOW WAS THE STUDY CONDUCTED?
This was a randomised, double-blind, placebo-controlled trial. This means that patients were assigned by chance to one of two treatment groups to receive either tocilizumab or placebo. Using chance in this way means that the groups are similar and allows the treatments to be compared objectively. During the treatment neither patients nor their doctors knew which group they were in. Overall, the study lasted for 24 weeks. For the first 16 weeks tocilizumab or placebo was given as an injection once a week. People were then monitored for the next 8 weeks to see how they did. Everyone taking part also received glucocorticoids, and these were rapidly tapered. The aim was to investigate whether treatment with tocilizumab resulted in higher rates of glucocorticoid-free remission (no signs or symptoms) after 16 weeks.
WHAT WERE THE MAIN FINDINGS OF THE STUDY?
The main finding was that tocilizumab was superior to placebo for achieving sustained glucocorticoid-free remission. Overall, 63.2% in the tocilizumab group and 11.8% in the placebo group achieved glucocorticoid-free remission after 16 weeks of treatment. Over the 8 weeks of follow-up, over 90% of people who had been taking tocilizumab maintained their remission status off-treatment. People taking tocilizumab also had a longer time to relapse than those taking placebo. The average time to first relapse was 130 days in the tocilizumab group, and 82 days in the placebo group. People on tocilizumab also needed to take less glucocorticoids than those in the placebo group. Over 16 weeks the total dose needed was 727 mg compared to 935 mg. Finally, there were fewer total side effects in the tocilizumab group than for people taking placebo.
ARE THESE FINDINGS NEW?
Yes. These results prove for the first time in a randomised, placebo-controlled study that tocilizumab can be used in newly diagnosed PMR to help achieve glucocorticoid-free remission in people undergoing rapid glucocorticoid tapering.
WHAT ARE THE LIMITATIONS OF THE STUDY?
One limitation is that this study did not look at whether the effect of tocilizumab lasts for longer than 8 weeks after stopping it. Future studies will be needed to see if drug-free remission could be maintained for longer than this.
WHAT DO THE AUTHORS PLAN ON DOING WITH THIS INFORMATION?
The authors plan to continue to follow the people in this study, and see how many in each group relapse over time.
WHAT DOES THIS MEAN FOR ME?
If you have PMR, you may be prescribed glucocorticoids. These medicines can help reduce your symptoms. In the future, other medicines such as tocilizumab might be used to help achieve steroid-free remission. If you have any concerns about your disease or its treatment, you should speak to your doctor.
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Date prepared: April 2022
Summary based on research article published on: 24 February 2022
From: Bonelli M, et al. Tocilizumab in patients with new onset polymyalgia rheumatica (PMR-SPARE): a phase 2/3 randomised controlled trial. Ann Rheum Dis 2022;81:838–44. doi:10.1136/annrheumdis-2021-221126
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