Clinical remission (IBD)
Immunology· appears in 400+ cited findings in this library
What it is and how the reviews use it
Clinical remission in Inflammatory Bowel Disease (IBD) is an endpoint used in clinical trials to assess the effectiveness of treatments. It measures the absence or significant reduction of disease activity, indicating a state where patients experience minimal to no symptoms. According to the ABBVIE INC — Humira FDA Review, clinical remission based on the Pediatric Crohn's Disease Activity Index (PCDAI) is defined as a score of less than or equal to 10 points.
Regulatory reviews in this library frequently use clinical remission as a key outcome. For instance, the ABBVIE INC — Humira FDA Review reported 40.0% of patients achieved PCDAI clinical remission at Week 26 in pediatric CD. The BRISTOL — Zeposia FDA Review noted 6% of patients in the placebo group achieved clinical remission. Furthermore, the JANSSEN BIOTECH — Tremfya FDA Review showed 40% corticosteroid-free clinical remission in prior biologic and/or JAK inhibitor failure patients treated with Guselkumab 200 mg.
Real examples — cited to the source page
| Humira | PCDAI clinical remission at Week 26 (pediatric CD < 40 kg, 20 mg EOW maintenance) | 40.0 | ABBVIE INC — Humira FDA Review, p.322 |
| Zeposia | Proportion of patients in clinical remission (placebo) | 6 | BRISTOL — Zeposia FDA Review, p.57 |
| Tremfya | Corticosteroid-free clinical remission (%) in prior biologic and/or JAK inhibitor failure patients (Guselkumab 200 mg) | 40 | JANSSEN BIOTECH — Tremfya FDA Review, p.257 |
| Velsipity | Clinical Remission at Week 12 (White) | 27.7 | Pfizer Inc. — Velsipity FDA Review, p.132 |
| Omvoh | Treatment Difference in Clinical Remission (Not Hispanic or Latino) | 24.6 | Eli Lilly and Company — Omvoh FDA Review, p.332 |
| Velsipity | Sustained clinical remission responders (%) | 2.2 | Pfizer Inc. — Velsipity EMA EPAR public assessment report, p.133 |
| Stelara | Clinical remission at Week 44 among patients in clinical remission to ustekinumab at Week 0 of Maintenance (Maintenance Study 3003) | 56.4 | Johnson & Johnson — Stelara FDA Review, p.127 |
| Rinvoq | CR (Clinical Remission based on DAS28CRP<2.6) | 18.5 | AbbVie Inc. — Rinvoq EMA EPAR public assessment report, p.90 |
Different drugs were studied in different trials — these values are not head-to-head comparisons.
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Figures are as stated in the cited source documents. Educational reference only — not medical or investment advice.