MHRA Approves Guselkumab for Inflammatory Bowel Disease
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved guselkumab (Tremfya, Janssen-Cilag Limited) for use in adults with Crohn's disease and ulcerative colitis (UC).
The drug is already licensed in the UK for plaque psoriasis and psoriatic arthritis.
The new indication covers patients with moderately to severely active Crohn's disease or UC who have not responded to other treatments or have experienced unacceptable side effects.
Guselkumab is a monoclonal antibody (IgG1-lambda) that inhibits interleukin-23 (IL-23)—a natural cytokine associated with inflammatory and immune responses—by selectively binding to its p19 subunit. This inhibits the proinflammatory actions of IL-23, thereby decreasing cytokine and chemokine release.
The European Medicines Agency extended the drug's indications in March.
Crohn's Disease: Remission in More Than Half of Patients
The MHRA said that clinical trials showed that guselkumab reduced symptoms such as diarrhoea and abdominal pain in patients with Crohn's disease.
Three studies involving around 1400 patients found that up to 56% achieved clinical remission after 12 weeks of treatment. In comparison, 15%-22% of patients on placebo reached remission.
Endoscopic response, indicating reduced intestinal inflammation, was seen in up to 41% of patients treated with guselkumab versus 11%-21% in the placebo group.
A follow up study published last year showed that 57%-75% of patients maintained remission to week 48, depending on the dose. Endoscopic remission at week 48 was reported in 17%-33% of treated patients.
Initial induction treatment is given by either intravenous infusion or injection every 4 weeks for three cycles. This is followed by maintenance therapy with subcutaneous injections every 4 or 8 weeks, depending on the induction phase response.
Pre-filled syringes or pens are available for self-administration.
Ulcerative Colitis: Long-Term Remission Achievable
In UC, guselkumab helps to reduce abdominal pain and inflammation of the intestinal lining, reducing fatigue and helping patients maintain normal activities.
According to the MHRA, 23% of patients receiving guselkumab achieved clinical remission after 12 weeks of induction treatment, compared with 8% on placebo.
With continued treatment, remission was reported in up to 50% of patients by week 44. In the placebo group, the remission rate was 19%.
A study extension, presented by the manufacturer at Digestive Disease Week this month, showed 72% of patients in clinical remission, with 99% of them remaining corticosteroid free for 8 or more weeks through to week 92. Among the 43% of trial patients in endoscopic remission at week 44, most (84%) maintained this outcome through to week 92.
Induction treatment for UC involves monthly intravenous infusions. Maintenance treatment is delivered by subcutaneous injection.
Treatment should be discontinued if there is no clinical response after 24 weeks.
Adverse Effects and Safety Monitoring
Guselkumab is associated with an increased risk of infections, particularly of the upper respiratory tract. Fungal and viral infections, such as tinea and herpes simplex, are also common.
Patients should be screened for tuberculosis before initiating treatment. Live vaccines are contraindicated during therapy.
Other commonly reported side effects include headache, injection site reactions, arthralgia, elevated liver enzymes, diarrhoea, and gastroenteritis.
Julian Beach, interim executive director of healthcare quality and access at the MHRA, said in a press release: 'We're assured that the appropriate regulatory standards of safety, quality, and efficacy for the approval of this new formulation have been met."
He added that the safety of guselkumab will be kept under close review. Healthcare professionals and patients are encouraged to report adverse reactions via the Yellow Card scheme.
A full list of side effects will be included in the Patient Information Leaflet and the Summary of Product Characteristics, available on the MHRA website within 7 days of approval.
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