An observational study of the TNF blocker Simponi (golimumab) in patients with ulcerative colitis found that it is a promising short-term treatment, but a large proportion of patients needed more of it after a few months to keep its benefits.
Patients who had not previously taken drugs blocking TNF-alpha were also seen to be more likely to respond to the treatment.
Researchers at the University of Valencia in Spain — who published “Short-term effectiveness of golimumab for ulcerative colitis: Observational multicenter study” in the World Journal of Gastroenterology — recruited 33 ulcerative colitis patients from several clinics in the region. A majority, 70%, had extensive disease at the study’s start. All the patients had an endoscopic Mayo score of 2 or 3, indicating moderate to severe disease.
Simponi is an antibody that blocks the actions of the cytokine TNF-alpha. Using such a medicine is common for treating ulcerative colitis, so the research team paid particular attention to the responses of patients who had been treated with the TNF blockers Remicade (infliximab) or Humira (adalimumab). Only 27.3 percent had never received such treatment.
Among those who had been treated with TNF blockers, 25 percent stopped the treatment because their condition did not respond to it, and a 58.3 percent had a failed or lost response, meaning they did not respond to the treatment or did but the effect did not last.
Researchers measured response using the Physician Global Assessment (PGA) or improvements in the Mayo score.
After 14 weeks, 69.7% of the patients had a clinical response — defined as a decrease in the partial Mayo score — and had stopped taking steroids. Also, 51.5% reached clinical remission without corticosteroids.
Using the PGA score, the study indicated that 55% of the patients responded to treatment and 24% went into remission. Among all those who were dependent on steroids at the study’s start, 70.8% were able to stop that treatment.
Further analyses indicated that not having a history of TNF-blocking treatment resulted in a better response.
While the study showed a good level of response in the short term, it noted that 27.3% of patients needed more of the treatment at the close of 14 weeks.
“In our study, golimumab allows steroid-sparing in a high number of steroid-dependent patients. It is associated to good clinical response in the first 14 wk. It may even be more effective in anti-TNF treatment naïve patients, although it is also a compelling treatment for experienced anti-TNF patients,” the researchers wrote. “More studies should be performed and will hopefully be published soon to confirm these conclusions.”
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