CIMZIA® (certolizumab pegol) significantly impacted health-related quality of life5,14
- The primary endpoint in PRECiSE 2 was a clinical Crohn's Disease Activity Index (CDAI) response at week 26 (defined as a decrease from baseline in CDAI score of ≥100) in patients with a baseline C-reactive protein (CRP) level of at least 10 mg/L14
PRECiSE 2—Inflammatory Bowel Disease Questionnaire (IBDQ) response (≥16 points) in patients with CRP ≥10 mg/L at baseline (ITT)1,14
Clinically meaningful improvement in health-related quality of life was evaluated using a patient-reported outcome instrument called the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ is a widely used 32-question, self-administered, disease-specific instrument that has been validated in Crohn's disease. Four domains are evaluated: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). A minimum clinically important difference was defined as an increase of ≥16 points. In PRECiSE 2, IBDQ response at week 26 was a key secondary endpoint.17
IBDQ scores revealed improvement in health-related quality of life, which evaluated17:
- Emotional function
- Social function
- Bowel symptoms
- Systemic symptoms
- CIMZIA 400 mg q4w
- Placebo q4w
- Baseline IBDQ score was 123 in both CIMZIA and placebo groups.
- IBDQ response was defined as an increase of ≥16 points in the total score
- All patients received a loading dose of CIMZIA 400 mg at weeks 0, 2, and 4
- ITT: intent-to-treat
- Concurrent administration of CIMZIA with certain biological DMARDs, including anakinra, abatacept, and rituximab, is not recommended due to an increased risk of serious infections.
- In premarketing controlled trials of all patient populations combined the most common adverse reactions (≥8%) were upper respiratory infections (18%), rash (9%) and urinary tract infections (8%).