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Clinical outcomes of golimumab as first, second or third anti-TNF agent in patients with moderate-to-severe Ulcerative Colitis

Taxonera study
Prescribing Information

SIMPONI is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.1

Download the Taxonera et al 2017 study from Inflamm Bowel Dis

Please refer to SPC for full information available at www.medicines.org.uk/emc.1

SIMPONI induces clinical response* and remission at 8 weeks as a first, second, or third anti-TNF agent in moderate-to-severe UC2

The short term primary end point was clinical response evaluated using the partial Mayo score at baseline and at week 8 (65% n=92/142, p=0.007).

Proportion of patients from each group achieving clinical response at week 8*

Clinical response graph

Proportion of patients from each group achieving clinical remission at week 8

Clinical remission graph

In conclusion, in this difficult-to-treat real-life cohort of patients with moderate-to-severe UC [SIMPONI] therapy was effective in inducing and maintaining clinical response2

*Clinical response was defined as a 3-point decrease from baseline in the partial Mayo score or a decrease of ≥50% in the partial Mayo score as well as a final partial Mayo score of ≤2.
Clinical remission was defined as a partial Mayo score of 0 or 1.

Aim
Study design
Baseline characteristics
Results
Overall short-term efficacy
Long-term efficacy
Safety
Conclusions
Induction response is a crucial indicator of long-term benefit

Abbreviations
SPC: Summary of Product Characteristics
TNF: tumour-necrosis factor-alpha
UC: Ulcerative Colitis

By study design dose escalation for secondary non-response during follow up was permitted as investigators discretion.

Real-world study data can be a useful source of information on the use of a product after licence. However, there may be limitations associated with the data obtained. These include the potential for coding and entry issues when obtaining data from databases, patients have not been randomised to medication, and prescribing bias may influence the results. Results will also be limited to the source data population.

References

  1. SIMPONI Summary of Product Characteristics.
  2. Taxonera C, Rodriguez C, Bertoletti F, et al. Clinical outcomes of golimumab as first, second or third anti-TNF agent in patients with moderate-to-severe ulcerative colitis. Inflamm Bowel Dis. 2017; 23(8):1394–1402.

For more information about SIMPONI® (golimumab):