Belimumab (Benlysta) for the treatment of systemic lupus erythematosus in children and teenagers

Introduction

Belimumab (trade name: Benlysta) has been approved in Germany since July 2011 for the treatment of active, autoantibody-positive systemic lupus erythematosus (SLE) in adults. This drug can be used as an add-on treatment during a phase of high disease activity if the standard treatment hasn't helped. Since October 2019, it has also been approved for this purpose in children aged 5 years and older, as well as in teenagers.

SLE is an autoimmune disease: The immune system attacks the body by producing antibodies against the body’s own proteins (autoantibodies). These autoantibodies enter the bloodstream and cause inflammations in various organs. This results in organ damage, especially in the kidneys.

SLE can lead to a wide range of symptoms. It often causes a reddish facial rash, joint and muscle pain, and exhaustion.

SLE often comes and goes in episodes. That means that acute phases of disease activity alternate with periods with hardly any symptoms.

Belimumab is an antibody that is thought to relieve the symptoms of SLE by inhibiting the body's .

Application

Belimumab is given through an infusion into a vein (an intravenous drip). In children and teenagers, the dose is based on body weight. The drip is given 14 and 28 days after the first use, and then every four weeks after that.

Belimumab is also available in pre-filled pens or syringes, but only for adults.

If the disease activity hasn't improved after half a year, the treatment should be stopped.

Other treatments

Children and teenagers aged 5 and over who have active, autoantibody-positive systemic lupus erythematosus receive optimized individual therapy if the standard treatments are not effective enough. What exactly this therapy involves will depend on things like which treatments have been tried before, which organs are affected and how severe the episode is.

The treatment is individually tailored by the doctor. It might include the use of the drugs hydroxychloroquine, chloroquine, NSAIDs, glucocorticoids, azathioprine and mycophenolate mofetil (if the kidneys are severely inflamed).

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into whether belimumab has any advantages or disadvantages when used as add-on therapy for autoantibody-positive systemic lupus erythematosus (SLE) compared with the standard treatments for the following group of people: children and teenagers aged 5 and older who still have high disease activity despite receiving the standard treatment.

But the manufacturer didn’t provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of a review by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The IQWiG 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 belimumab (Benlysta).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Belimumab (systemic lupus erythematosus in children and teenagers) – Benefit assessment according to § 35a Social Code Book V. Dossier assessment; Commission 19-94. February 13, 2020. (IQWiG reports; Volume 882).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on March 12, 2020
Next planned update: 2023

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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