Introduction

The drug sarilumab (trade name: Kevzara) has been approved in Germany since June 2017 for the treatment of moderate to severe rheumatoid arthritis in adults. It is an option if previous treatments weren't effective enough or weren't well tolerated.

There are many different rheumatic diseases, but rheumatoid arthritis is probably the best known. In this condition, several joints are permanently inflamed and may become deformed and stiff over time. Muscles also become weaker.

In advanced rheumatoid arthritis, stiff joints can make daily tasks difficult. Other symptoms such as pain and fatigue can be a big problem too.

Various kinds of medications are used in the treatment of rheumatoid arthritis to relieve the symptoms, reduce the inflammation and keep the joints mobile for as long as possible. There are two main types of treatments, known as disease-modifying therapy and symptomatic therapy.

Disease-modifying therapy aims to stop the progression of rheumatoid arthritis. Patients are first given conventional disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate, azathioprine, leflunomide, or sulfasalazine. If these are no longer effective enough, medications produced using biotechnology (biological drugs, or biologics) can be used instead. These include the drugs abatacept, etanercept, certolizumab pegol, golimumab, adalimumab and tocilizumab.

Sarilumab is an antibody that is used on its own or in combination with methotrexate to reduce inflammation and relieve symptoms.

Application

The drug is injected into the skin once every two weeks. For this purpose, pre-filled pens or pre-filled syringes are available at doses of 150 or 200 mg. The recommended dose is 200 mg. The dose can be individually adjusted if necessary.

Other treatments

Depending on the course of the disease or previous treatments, patients with moderate to severe rheumatoid arthritis can use the following standard medications:

  • Group 1: People whose condition isn't expected to get worse quickly, and who have had previous treatment with a single conventional DMARD that wasn’t effective enough, can switch to either a different conventional DMARD or to a combination of several conventional DMARDs. The same applies if treatment with a single conventional DMARD wasn't tolerated.
  • Group 2: People whose condition is expected to get worse quickly, and who have had previous treatment with a single conventional DMARD (e.g. methotrexate or azathioprine) that wasn’t effective enough, can use biological drugs combined with methotrexate. If methotrexate isn’t well tolerated, the biological drug can be used on its own.
  • Group 3: If a biological drug isn’t effective enough when used alone or in combination therapy, patients can switch to a different biological drug in combination with methotrexate. If methotrexate isn’t well tolerated, the biological drug can be used on its own. In severe rheumatoid arthritis, rituximab is another option.

Assessment

In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of sarilumab compared with the standard treatments for moderate to severe rheumatoid arthritis.

The manufacturer didn't provide data on the patient groups 1 and 3. It is therefore not possible to determine whether the new drug sarilumab has any advantages or disadvantages for these people when compared to the standard treatments.

The manufacturer provided one study involving people who had moderate to severe rheumatoid arthritis which could be used to look into the effect of treatments in patient group 2. This study involved people whose condition is expected to get worse quickly, and who have had treatment with one or several conventional DMARDs which wasn’t effective enough. To seek answers to their questions, the researchers at IQWiG analyzed the data of 169 patients. Half of the participants received the standard treatment adalimumab, while the other half had treatment with sarilumab. The study only included people who hadn't tolerated the drug methotrexate. Because of this, it didn't compare combined treatment using sarilumab and methotrexate with the standard treatment. The study lasted about 24 weeks. The following results were found.

What are the advantages of sarilumab?

  • Low disease activity: The study suggests that sarilumab has an advantage here. About 45 to 46 out of 100 people who had treatment with sarilumab had low disease activity, compared to only 10 to 20 out of 100 people who had the standard treatment. This advantage was also reflected in the patients’ perception: Those patients who had treatment with sarilumab reported a bigger subjective improvement in disease activity than those who had the standard treatment.
  • Pain: Here too, the study suggests that sarilumab has an advantage compared with the standard treatment.
  • Health-related quality of life: The study suggests that the new treatment offers an advantage regarding physical quality of life. There were no differences between the treatments in terms of emotional quality of life.
  • Physical functioning: Here too, there was weak evidence that sarilumab has an advantage when compared with the standard treatment adalimumab: Physical functioning improved in about 67 out of 100 people who had treatment with sarilumab, compared to about 49 out of 100 people who had the standard treatment.

No difference

  • Rheumatoid arthritis remission: Remission means that the symptoms almost go away permanently, or at least temporarily. There were no differences between the treatments here.
  • Serious side effects: About 5 to 6 out of 100 people were affected in both treatment groups.
  • There was also no difference between the treatment groups in terms of the following:
    • Number of joints that were painful to the touch and swollen
    • Joint stiffness in the morning
    • General health
    • Exhaustion
    • Treatment stopped due to side effects
    • Infections and severe infections

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of sarilumab (Kevzara).