Effect of risankizumab on health‐related quality of life in patients with Crohn's disease: results from phase 3 MOTIVATE, ADVANCE and FORTIFY clinical trials

Abstract

Summary Background Crohn's disease has a substantial negative impact on health‐related quality of life (HRQoL). Aim To examine the effects of risankizumab on HRQoL in Crohn's disease Methods We analysed data from patients with Crohn's disease from 12‐week induction trials ADVANCE (N = 850) and MOTIVATE (N = 569) with risankizumab 600 mg or 1200 mg intravenous (IV) versus placebo IV and a 52‐week maintenance trial FORTIFY (N = 462) with risankizumab 180 or 360 mg subcutaneous (SC) versus placebo SC. Outcomes included Inflammatory Bowel Disease Questionnaire (IBDQ), Functional Assessment of Chronic Illness Therapy‐Fatigue (FACIT‐F), 36‐item Short Form Health Survey (SF‐36), EuroQol 5‐Dimension‐5‐Level (EQ‐5D‐5L) and work productivity. The mean change and percentages of patients achieving clinically meaningful improvement in all outcomes were determined at weeks 12 and 52. Results At week 12, more patients in the risankizumab 600 or 1200 mg groups achieved IBDQ response than with placebo (ADVANCE: 70.2%, 75.5% vs. 47.8%, p ≤ 0.001; MOTIVATE: 61.7%, 68.5% vs. 48.2%, p ≤ 0.01) and FACIT‐F response (ADVANCE: 51.3%, 48.0% vs. 35.7%, p ≤ 0.01; MOTIVATE: 44.2%, 49.1% vs. 33.7%, p < 0.05). These improvements persisted at week 52 with risankizumab maintenance treatment. Similar trends were observed for SF‐36 physical and mental component summary scores, EQ‐5D‐5L and activity impairment within work productivity measures. Conclusions Risankizumab induction therapy (600 or 1200 mg IV) led to clinically meaningful improvements in disease‐specific and general patient‐reported outcomes, including fatigue, in patients with moderate to severe Crohn's disease. These improvements were sustained after 52 weeks of risankizumab (180 or 360 mg SC) maintenance therapy.

Risankizumab (Skyrizi)

“…The CDAI and PRO2 correlates poorly with scores of endoscopic disease severity and with fecal (calprotectin) and serum biomarkers of inflammation CRP. [29][30][31] Thus, to detect and assess disease activity and align with current treatment target recommendations, patients should also be periodically evaluated for disease activity via fecal calprotectin testing, other non-invasive testing, and periodic endoscopic evaluation according to the Canadian Specialist Group to ensure that the therapy is controlling disease activity, not only symtpoms� 32…”

Development and validation of a scale to measure the care needs of Crohn's Disease Patients

“…While enteral nutrition improves nutritional status, prolonged tube feeding, whether in a hospital or home setting, not only increases the di culty of self-management for patients 6, but also imposes signi cant economic burdens 7,8 . Medications and surgeries provide only temporary relief of symptoms, necessitating continuous monitoring of the condition, prompting patients to seek timely medical attention 9 . Throughout the protracted course of the disease, patients have diverse needs in terms of medical, social support, and psychological aspects 10 .…”

Development and validation of a scale to measure the care needs of Crohn’s disease patients: a mixed-methods study

“…While enteral nutrition improves nutritional status, prolonged tube feeding, whether in a hospital or home setting, not only increases the difficulty of self-management for patients [ 6 ], but also imposes significant economic burdens [ 7 , 8 ]. Medications and surgeries provide only temporary relief of symptoms, necessitating continuous monitoring of the condition and prompting patients to seek timely medical attention [ 9 ]. Throughout the protracted course of the disease, patients have diverse needs in terms of medical, social support, and psychological aspects [ 10 ].…”