Autoimmune ILD subgroup results
FVC DECLINE
JASCAYD® 18 mg demonstrated a consistent reduction in FVC decline across patient populations at week 521
FVC, forced vital capacity; ILD, interstitial lung disease.
SECONDARY ENDPOINT
In patients with autoimmune ILDs, JASCAYD® 18 mg improved survival as shown by a nominally significant reduction in the risk of death vs placebo at the end of trial analysis3
The key secondary endpoint (time to first acute ILD exacerbation, first hospitalization for respiratory cause, or death over duration of trial) was not met. The analyses of the secondary and further endpoints of time to death and time to progression were not part of confirmatory testing and are explorative in nature.1
In patients with autoimmune ILDs, JASCAYD® improved survival as demonstrated by an early and sustained reduction in risk of death vs placebo at the end of trial analysis3
SAFETY AND TOLERABILITY
JASCAYD® had a favorable tolerability and safety profile3
- No required liver or lab monitoring2
ADVERSE EVENTS IN ≥10% OF JASCAYD® PATIENTS AND MORE OFTEN THAN PLACEBO IN AUTOIMMUNE ILD PATIENTS3
Placebo (n=100) | JASCAYD® 18 mg (n=113) | |
|---|---|---|
| Diarrhea | 24% | 31% |
| Anxiety | 11% | 15% |
| Weight decreased | 6% | 15% |
| Nausea | 4% | 14% |
| Cough | 12% | 13% |
| Nasopharyngitis | 11% | 13% |
| Depression | 11% | 13% |
| Decreased appetite | 7% | 12% |
| Arthralgia | 4% | 11% |
ADVERSE EVENTS IN ≥10% OF JASCAYD® PATIENTS AND MORE OFTEN THAN PLACEBO IN AUTOIMMUNE ILD PATIENTS3
Placebo (n=100) | JASCAYD® 9 mg (n=112) | |
|---|---|---|
| Diarrhea | 24% | 29% |
| Cough | 12% | 13% |
| Pneumonia | 16% | 10% |
| Anxiety | 11% | 10% |
| Nasopharyngitis | 11% | 15% |
| Depression | 11% | 8% |
| Condition aggravated | 17% | 8% |
| COVID-19 | 11% | 7% |
| Weight decreased | 6% | 11% |
| Decreased appetite | 7% | 4% |
| Arthralgia | 4% | 10% |
| Nausea | 4% | 5% |
Only 2 patients receiving JASCAYD® discontinued due to diarrhea compared to 0 patients on placebo3
RISK OF INFECTION
JASCAYD® demonstrated no increased risk of upper respiratory tract infection compared to placebo3
In autoimmune ILD subgroup
Placebo (n=100) | JASCAYD® 18 mg (n=113) | |
|---|---|---|
| Risk of upper respiratory tract infection | 19% | 20% |
In autoimmune ILD subgroup
Placebo (n=100) | JASCAYD® 9 mg (n=112) | |
|---|---|---|
| Risk of upper respiratory tract infection | 19% | 12% |
Quicklinks
References
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Maher TM, Assassi S, Azuma A, et al. FIBRONEER-ILD Trial Investigators. Nerandomilast in patients with progressive pulmonary fibrosis. N Engl J Med. 2025;392(22):2203-2214.
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JASCAYD® UAE Local SmPC; May 2026.
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Hoffmann-Vold AM, Assassi S, Cottin V, et al. Efficacy and safety of nerandomilast in patients with autoimmune disease-related progressive pulmonary fibrosis: subgroup analysis of the FIBRONEER-ILD trial. October 2025; Chicago, Illinois. Poster available from: https://www.usscicomms.com/respiratory/ACR2025/Hoffmann-Vold.
MLR ID: PC-AE-102895
Expiry Date: 10/05/2028