Nintedanib slows lung disease progression in systemic sclerosis over 100 weeks: SENSCIS trial
USA: Nintedanib provided a sustained benefit of slowing systemic sclerosis-associated interstitial lung disease (SSc-ILD) progression over 100 weeks with manageable adverse events, according to recent data from the SENSCIS trial. The findings of the study were published in ACR Open Rheumatology.
Participants with systemic sclerosis-associated interstitial lung disease were randomized to receive nintedanib or placebo in the SENSCIS trial until the last participant reached week 52 but for 100 weeks or less. It was found that nintedanib reduced the rate of decline in forced vital capacity (FVC) (ml/year) over 52 weeks by 44% (41 ml) versus placebo.
In the study, Shervin Assassi, University of Texas McGovern Medical School, Houston, and colleagues examined the effect of nintedanib over the entire SENSCIS trial.
For this purpose, the researchers descriptively assessed the annual rate of decline in FVC (ml/year) over the whole trial using 1) on-treatment data plus off-treatment data from participants who prematurely discontinued treatment (intent-to-treat analysis) and 2) only on-treatment data to assess the effect of nintedanib in participants who remained on treatment.
Based on the study, the researchers found the following:
- In the intent-to-treat analysis, the adjusted mean (SE) annual rate of decline in FVC over 100 weeks was −54.9 and −88.8 ml/year in the nintedanib (n = 287) and placebo (n = 288) groups, respectively (difference 34.0 ml/year).
- In the on-treatment analysis, the adjusted mean (SE) annual rate of decline in FVC over 100 weeks was −55.1 and −94.0 ml/year in the nintedanib (n = 286) and placebo (n = 288) groups, respectively (difference 38.9 ml/year).
- The adverse event profile of nintedanib over 100 weeks was consistent with that observed over 52 weeks.
"Analyses suggest that the effect of nintedanib on slowing the progression of SSc-ILD observed over 52 weeks persisted over the duration of the SENSCIS trial," the authors wrote.
"The results of the SENSCIS trial suggest that nintedanib provides a sustained benefit on slowing Sc-ILD progression, with adverse events that are manageable for most patients," they conclude.
Reference:
Assassi S, Distler O, Allanore Y, Ogura T, Varga J, Vettori S, Crestani B, Voss F, Alves M, Stowasser S, Maher TM; SENSCIS trial investigators. Effect of Nintedanib on Progression of Systemic Sclerosis-Associated Interstitial Lung Disease Over 100 Weeks: Data From a Randomized Controlled Trial. ACR Open Rheumatol. 2022 Jul 19. doi: 10.1002/acr2.11483. Epub ahead of print. PMID: 35852465.
