From the Guidelines
Certolizumab pegol did not receive European Medicines Agency (EMA) approval for Crohn's disease due to concerns about its efficacy data, as evidenced by the AGA clinical practice guidelines which suggest that certolizumab pegol may not be effective for induction of fistula remission 1. The EMA's Committee for Medicinal Products for Human Use (CHMP) determined that the benefits of certolizumab pegol did not outweigh its risks for treating Crohn's disease based on the clinical trial results submitted. Some key points to consider in the management of Crohn's disease include:
- The use of anti-TNFα agents, such as infliximab and adalimumab, which have more robust evidence supporting their use in Crohn's disease 1.
- The use of vedolizumab and ustekinumab, which are recommended for patients who fail to achieve complete remission with anti-TNF therapy 1.
- The importance of evaluating patients for symptomatic response to therapy and modifying treatment as needed 1. The decision not to approve certolizumab pegol for Crohn's disease in Europe highlights the regulatory differences between regions, as certolizumab pegol (marketed as Cimzia) did receive approval from the US FDA for Crohn's disease. Patients in Europe with Crohn's disease should be aware that their treatment options may differ from those in other regions, and they should discuss alternative TNF-alpha inhibitors or other treatment approaches with their healthcare providers. It is also worth noting that the Canadian Association of Gastroenterology clinical practice guideline for the management of luminal Crohn's disease does not include certolizumab pegol as a recommended treatment option due to its lack of licensure in Canada and Europe 1.
From the Research
Background on Certolizumab Pegol
- Certolizumab pegol (CZP) is a tumor necrosis factor-alpha (TNF-alpha) inhibitor used for the treatment of Crohn's disease (CD) among other conditions.
- It has been approved by the Food and Drug Administration (FDA) for the treatment of CD, but its approval status with the European Medicines Agency (EMA) for this indication is not specified in the provided studies.
Efficacy of Certolizumab Pegol in Crohn's Disease
- Studies have shown that CZP is effective in inducing and maintaining clinical remission in patients with moderate to severe CD 2, 3, 4, 5.
- A study published in 2015 found that CZP was effective and well-tolerated for the treatment of CD in a large tertiary care center, with a probability of steroid-free complete response at 26 weeks of 19.9% 2.
- Another study published in 2009 reviewed the efficacy and tolerability of CZP in the treatment of CD and found that it had moderate efficacy in inducing clinical remission and response 3.
- A Cochrane review published in 2019 found that CZP was superior to placebo in achieving clinical remission and response at week 8, with moderate certainty evidence 4.
- A more recent Cochrane review published in 2022 found that CZP probably results in a large reduction in failure to maintain clinical remission and response at week 26, with moderate certainty evidence 5.
Safety of Certolizumab Pegol
- The safety profile of CZP has been evaluated in several studies, including a pooled analysis of data from clinical trials published in 2016, which found that the overall rates of adverse events, serious infections, malignancies, and psoriasis did not increase with long-term treatment 6.
- The study found that the incidence rates of serious adverse events, serious infections, and malignancies were low and similar between the CZP and placebo groups 6.
European Medicines Agency (EMA) Approval
- Unfortunately, the provided studies do not specifically address why CZP did not receive EMA approval for Crohn's disease.
- It is possible that the EMA may have had concerns regarding the efficacy or safety of CZP for this indication, but without further information, it is not possible to determine the exact reasons for the lack of approval.