The safety profile of nintedanib was consistent with that reported in a previous trial<\/p>\n
Introduction<\/strong><\/p>\n Systemic sclerosis is an autoimmune disease that causes abnormalities in the skin, joints, and internal Involvement of lung tissue often develops early in the disease. This so called systemic sclerosis- Results from a previous trial showed that a drug called nintedanib reduced the rate of decline in people\u2019s What did the authors hope to find?<\/strong><\/p>\n The authors wanted to monitor people\u2019s FVC and the picture of adverse events (side effects) during a Who was studied?<\/strong><\/p>\n The study looked at 473 people with SSc-ILD. Everyone had already taken part in an earlier trial, where How was the study conducted?<\/strong><\/p>\n This was an open-label extension study. This means that both patients and their doctors knew which In the original trial, people had been divided (\u201crandomised\u201d) to receive either nintedanib 150 mg twice per The authors compared the long-term FVC results between these two groups. They also evaluated What was the main finding?<\/strong><\/p>\n The main finding was that the adverse events and side effects of nintedanib in the extension study were Are these findings new?<\/strong><\/p>\n Yes, these are new findings.<\/p>\n What are the limitations of this study?<\/strong><\/p>\n One limitation is that efficacy cannot be accurately measured in this kind of open-label study due to a What do the authors plan to do with this information?<\/strong><\/p>\n The authors suggest that in clinical practice nintedanib should be started quickly in people with SSc-ILD What does this mean for me?<\/strong><\/p>\n If you have SSc-ILD, there are new treatment options on the horizon. The right treatment decision for If you have any questions about your disease or its treatment, speak to your healthcare team.<\/p>\n Disclaimer:<\/strong> This is a summary of a scientific article written by a medical professional (\u201cthe Original Article\u201d). The Summary is written to assist non medically trained readers to understand general points of the Original Article. It is supplied \u201cas is\u201d without any warranty. You should note that the Original Article (and Summary) may not be fully relevant nor accurate as medical science is constantly changing and errors can occur. It is therefore very important that readers not rely on the content in the Summary and consult their medical professionals for all aspects of their health care and only rely on the Summary if directed to do so by their medical professional. Please view our full Website Terms and Conditions<\/a>.<\/p>\n Date prepared: <\/strong>July 2023 Copyright \u00a9 2023 BMJ Publishing Group Ltd & European League Against Rheumatism. Medical professionals may print copies for their and their patients and students non commercial use. Other individuals may print a single copy for their personal, non commercial use. For other uses please contact our Rights and Licensing Team<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":" 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 […]<\/p>\n
\norgans, including the lungs. It is associated with changes in blood vessels that causes scarring or
\nthickening in affected tissues, such as the skin and lungs. Systemic sclerosis is more common in women
\nthan men, and most often develops between the ages of 30\u201350 years.<\/p>\n
\nassociated interstitial lung disease (shortened to SSc-ILD) has a variable course and can worsen over
\ntime in some people. SSc-ILD is characterised by an increase in scarring and a decline in a measure of
\nlung function called forced vital capacity (shortened to FVC). This is the maximum amount of air you can
\npush out from your lungs after taking a full breath.<\/p>\n
\nFVC over 1 year. Nintedanib inhibits a protein within cells called tyrosine kinase, and therefore has anti-
\ninflammatory properties, as well as being anti-scarring or anti-fibrotic.<\/p>\n
\nlonger period of treatment than the 1 year of the original study.<\/p>\n
\nthey had received either nintedanib or placebo for at least 1 year, and then transitioned into a second
\nyear of treatment.<\/p>\n
\ngroup they were in.<\/p>\n
\nday or placebo for 1 year. In the extension, everyone received nintedanib for a further year. This means
\npeople were in one of two groups \u2013 the continuers, who received the drug for a full 2-year period, and
\nthe initiators, who received placebo in the original trial, and then were switched to nintedanib in the
\nextension period.<\/p>\n
\nadverse events and side effects.<\/p>\n
\nconsistent with those reported in the original trial. Diarrhoea was reported in about 70% of both
\ncontinuers and initiators. Overall, nintedanib had to be permanently stopped in 5% of continuers and
\n22% of initiators.
\nThe change in FVC was also similar to that observed in the nintedanib group in the original trial. Mean
\nchanges were a decrease of 58 millilitres in the volume that could be forced out of the lungs for
\ncontinuers, and a decrease of 44 millilitres for initiators. Both these declines were much less than what
\nhad been seen for people taking placebo in the original trial.<\/p>\n
\nlack of a placebo group, so long-term efficacy will have to be further investigated. Further limitations of
\nthe analyses include the gradual loss of patients over the course of the trial and the selection bias
\npotentially related to the fact that people who agreed to take part may have had fewer adverse events or
\nbetter lung function in the first place.<\/p>\n
\nto slow the usual decline in lung function that is seen in this disease.<\/p>\n
\nyou 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
\npreferences.<\/p>\n
\nSummary based on research article published on: <\/strong>November 10, 2022
\nFrom: <\/strong>Allanone Y, et al. Continued treatment with nintedanib in patients with systemic sclerosis-
\nassociated interstitial lung disease: data from SENSCIS-ON. Ann Rheum Dis 2022;81(12):1722\u20139. doi:10.1136\/annrheumdis-2022-222564<\/p>\n