Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn’s Disease

Crohn’s disease (CD) leads to a poor health-related quality of life (HRQoL). This review aimed to investigate the effect of biological agents and small-molecule drugs in improving the HRQoL of patients with moderate to severe CD. We adopted a systematic protocol to search PubMed and Cochrane Central Register of Controlled Trials (CENTRAL), which was supplemented with manual searches. Eligible studies were RCTs that matched the research objective based on population, intervention, comparison and outcomes. Studies in paediatric populations, reviews and conference abstracts were excluded. Covidence was used for screening and data extraction. We assessed all research findings using RoB2 and reported them narratively. We included 16 multicentre, multinational RCTs in this review. Of the 15 studies that compared the effect of an intervention to a placebo, 9 were induction studies and 6 investigated maintenance therapy. Of these, 13 studies showed a significant (p < 0.05) improvement in the HRQoL of patients with CD. One non-inferiority study compared the intervention with another active drug and favoured the intervention. This systematic review reported a substantial improvement in the HRQoL of patients with CD using biological agents and small-molecule drugs. These pharmaceutical substances have the potential to improve the HRQoL of patients with CD. However, further large clinical trials with long-term follow-up are essential to validate these findings.

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“…Four studies met the inclusion criteria. However, we excluded those studies as there was no data about HRQoL outcomes [27][28][29][30].…”

Section: Resultsmentioning

confidence: 99%

Health-Related Quality of Life of Patients Treated with Biological Agents and New Small-Molecule Drugs for Moderate to Severe Crohn’s Disease: A Systematic Review

Aladraj

Abdulla

Guraya

et al. 2022

JCM

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“…In a phase 2 study of moderate-to-severe CD (SERENITY), at 12 weeks, mirikizumab at 600 and 1,000 mg had significantly higher endoscopic response rates than that of the placebo (p = 0.003, p < 0.001, respectively). The endoscopic response remained evident at 52 weeks [85].…”

Section: Promising Biologics and Smds In Late-phase Developmentmentioning

confidence: 89%

Management of inflammatory bowel disease beyond tumor necrosis factor inhibitors: novel biologics and small-molecule drugs

Kim

2022

Korean J Intern Med

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The incidence and prevalence of inflammatory bowel disease (IBD), comprising Crohn's disease and ulcerative colitis, have increased in Asia and developing countries. In the past two decades, anti-tumor necrosis factor (TNF) agents have revolutionized the treatment of IBD, in part by decreasing the rates of complications and surgery. Although anti-TNF agents have changed the course of IBD, there are unmet needs in terms of primary and secondary non-responses and side effects such as infections and malignancies. Novel biologics and small-molecule drugs have been developed for IBD, and the medical treatment options have improved. These drugs include sphingosine-1-phosphate receptor modulators and anti-integrins to block immune cell migration, and cytokine and Janus kinase inhibitors to block immune cell communications. In this review, we discuss the approved novel biologics and small-molecule drugs, including several of those in the late stages of development, for the treatment of IBD.

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“…Extended doses of mirikizumab (additional 12 weeks) produced a clinical response in up to 50% of patients who did not have a response post-12 weeks induction, most of whom maintained clinical response for up to 52 weeks 26 27. Another CD RCT showed statistically significant endoscopic and clinical response at week 12 for all mirikizumab groups versus placebo (200 mg: 25.8%, p=0.079; 600 mg: 37.5%, p=0.003; 1000 mg: 43.8%, p<0.001; Placebo: 10.9 %) 26–28. Several phase 3 UC trials are ongoing including LUCENT 1 (NCT03518086) and LUCENT 2 (NCT03524092).…”

Section: Novel Therapiesmentioning

confidence: 95%

“…26 27 Another CD RCT showed statistically significant endoscopic and clinical response at week 12 for all mirikizumab groups versus placebo (200 mg: 25.8%, p=0.079; 600 mg: 37.5%, p=0.003; 1000 mg: 43.8%, p<0.001; Placebo: 10.9 %). [26][27][28] Several phase 3 UC trials are ongoing including LUCENT 1 (NCT03518086) and LUCENT 2 (NCT03524092).…”

Section: Il12/il23 Inhibitorsmentioning

confidence: 99%

IBD therapeutics: what is in the pipeline?

Toskas

Akbar

2022

Frontline Gastroenterol

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Inflammatory bowel disease (IBD) is an idiopathic long-term relapsing and remitting disorder including ulcerative colitis and Crohn’s disease. The aim of therapy is to induce and maintain remission. Anti-TNF therapies dramatically improved clinical outcomes but primary failure or secondary loss is a common problem as well as potential side effects potentially limiting efficacy and long-term use. The advent of new targeted agents with the potential for greater safety is welcomed in IBD and offers the potential for different agents as the disease becomes refractory or even combination therapies to maximise effectiveness without compromising safety in the future. More data are required to understand the best positioning in pathways and longer-term safety effects.

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Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn’s Disease

Cited by 89 publications

References 20 publications

Health-Related Quality of Life of Patients Treated with Biological Agents and New Small-Molecule Drugs for Moderate to Severe Crohn’s Disease: A Systematic Review

Health-Related Quality of Life of Patients Treated with Biological Agents and New Small-Molecule Drugs for Moderate to Severe Crohn’s Disease: A Systematic Review

Management of inflammatory bowel disease beyond tumor necrosis factor inhibitors: novel biologics and small-molecule drugs

IBD therapeutics: what is in the pipeline?

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