The safety profile of nintedanib was consistent with that reported in a previous trial

Introduction

Systemic sclerosis is an autoimmune disease that causes abnormalities in the skin, joints, and internal
organs, including the lungs. It is associated with changes in blood vessels that causes scarring or
thickening in affected tissues, such as the skin and lungs. Systemic sclerosis is more common in women
than men, and most often develops between the ages of 30–50 years.

Involvement of lung tissue often develops early in the disease. This so called systemic sclerosis-
associated interstitial lung disease (shortened to SSc-ILD) has a variable course and can worsen over
time in some people. SSc-ILD is characterised by an increase in scarring and a decline in a measure of
lung function called forced vital capacity (shortened to FVC). This is the maximum amount of air you can
push out from your lungs after taking a full breath.

Results from a previous trial showed that a drug called nintedanib reduced the rate of decline in people’s
FVC over 1 year. Nintedanib inhibits a protein within cells called tyrosine kinase, and therefore has anti-
inflammatory properties, as well as being anti-scarring or anti-fibrotic.

What did the authors hope to find?

The authors wanted to monitor people’s FVC and the picture of adverse events (side effects) during a
longer period of treatment than the 1 year of the original study.

Who was studied?

The study looked at 473 people with SSc-ILD. Everyone had already taken part in an earlier trial, where
they had received either nintedanib or placebo for at least 1 year, and then transitioned into a second
year of treatment.

How was the study conducted?

This was an open-label extension study. This means that both patients and their doctors knew which
group they were in.

In the original trial, people had been divided (“randomised”) to receive either nintedanib 150 mg twice per
day or placebo for 1 year. In the extension, everyone received nintedanib for a further year. This means
people were in one of two groups – the continuers, who received the drug for a full 2-year period, and
the initiators, who received placebo in the original trial, and then were switched to nintedanib in the
extension period.

The authors compared the long-term FVC results between these two groups. They also evaluated
adverse events and side effects.

What was the main finding?

The main finding was that the adverse events and side effects of nintedanib in the extension study were
consistent with those reported in the original trial. Diarrhoea was reported in about 70% of both
continuers and initiators. Overall, nintedanib had to be permanently stopped in 5% of continuers and
22% of initiators.
The change in FVC was also similar to that observed in the nintedanib group in the original trial. Mean
changes were a decrease of 58 millilitres in the volume that could be forced out of the lungs for
continuers, and a decrease of 44 millilitres for initiators. Both these declines were much less than what
had been seen for people taking placebo in the original trial.

Are these findings new?

Yes, these are new findings.

What are the limitations of this study?

One limitation is that efficacy cannot be accurately measured in this kind of open-label study due to a
lack of a placebo group, so long-term efficacy will have to be further investigated. Further limitations of
the analyses include the gradual loss of patients over the course of the trial and the selection bias
potentially related to the fact that people who agreed to take part may have had fewer adverse events or
better lung function in the first place.

What do the authors plan to do with this information?

The authors suggest that in clinical practice nintedanib should be started quickly in people with SSc-ILD
to slow the usual decline in lung function that is seen in this disease.

What does this mean for me?

If you have SSc-ILD, there are new treatment options on the horizon. The right treatment decision for
you will be made on a case-by-case basis, taking into account the severity of your lung disease, risk factors for progression, any other manifestations of your systemic sclerosis, and your personal
preferences.

If you have any questions about your disease or its treatment, speak to your healthcare team.

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Date prepared: July 2023
Summary based on research article published on: November 10, 2022
From: Allanone Y, et al. Continued treatment with nintedanib in patients with systemic sclerosis-
associated interstitial lung disease: data from SENSCIS-ON. Ann Rheum Dis 2022;81(12):1722–9. doi:10.1136/annrheumdis-2022-222564

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