What the trial was testing
The VOLTAIRE-CD enrolled 147 patients with crohn's disease. The study was sponsored by Boehringer Ingelheim and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
About 9 in 10 patients improved on the biosimilar, matching the original drug's results.
The lancet. Gastroenterology & hepatology · 2021 · NCT02871635
These findings — that patients on the biosimilar saw meaningful symptom reduction within 4 weeks — were published in the The lancet. Gastroenterology & hepatology and represent the headline result of the study.
Researchers tracked outcomes across 147 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with crohn's disease, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
BI 695501 is now FDA-approved as a biosimilar alternative to Humira for Crohn's disease and costs less than the original. If you're taking Humira or considering starting it, ask your doctor whether this biosimilar might work for you. The study showed patients could also safely switch from Humira to BI 695501 without losing benefits.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open crohn's disease trials
Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar
In a population of adult patients followed for Crohn's disease, who had previously agreed to replace Stelara® with a biosimilar of ustekinumab (Uzpruvo®) and were followed over a period of 12 months under usual medical practice conditions. * Main objective: To assess the maintenance of the biosimilar of ustekinumab at 12 months without returning to the reference treatment * Secondary objectives: * To describe the factors associated with the maintenance of the biosimilar * To evaluate the evolution of patients' quality of life * To assess the rate of maintenance of clinical remission at M12 * To describe the acceptability of the biosimilar treatment by patients * To evaluate patient satisfaction * To evaluate treatment tolerance * To describe the reasons for treatment discontinuation that occurred during follow-up * To describe the profile of patients who discontinued treatment upon their request.
Analysis of Barriers and Facilitators to Adapted Physical Activity for Pediatric Patients With Chronic Inflammatory Bowel Diseases
This study aims to identify perceived barriers and facilitators to regular physical activity among children and adolescents with inflammatory bowel disease (IBD) followed in pediatric gastroenterology. Approximately 60 participants aged 10-17 years will complete two self-administered questionnaires (CAPAS-Q for physical activity/sedentary behavior and IMPACT-III for health-related quality of life) and take part in a single semi-structured interview exploring experiences, obstacles, and levers to support sustainable physical activity. Relevant clinical data (disease characteristics, treatment and selected routine clinical parameters) will be extracted from the medical record. Participation is limited to one visit (about 45-60 minutes) during a routine hospital appointment, with no additional intervention or follow-up required.