The study, “Adalimumab Effectiveness Up to Six Years in Adalimumab-naïve Patients with Crohn’s Disease: Results of the PYRAMID Registry,” was published in the journal Inflammatory Bowel Diseases.
Humira is a biological therapy manufactured by AbbVie, approved by the U.S. Food and Drug Administration for the treatment of inflammatory bowel disease (IBD). It was approved to treat Crohn’s in 2007 and ulcerative colitis in 2012.
The therapy consists of an antibody that specifically binds and blocks an inflammatory protein called tumor necrosis factor alpha or TNFa. Blocking TNFa reduces inflammation and consequently IBD symptoms.
Humira induced remission in CD patients in different clinical trials, and various studies have shown that it is safe and effective when used for up to four years.
The international Pyramid registry (NCT00524537) assessed the long-term safety of Humira use in clinical practice, according to the specifications of the product label, in different countries where the treatment was approved. It enrolled patients from the U.S., Canada, Europe, South Africa, Australia, and New Zealand from Sept. 5, 2007, to Dec. 14, 2009.
In the present study, the researchers studied the efficacy and safety of the treatment in Pyramid registry participants with moderate to severe CD who had not taken Humira before enrollment and followed them for at least six years. The authors evaluated 2,057 adults with Crohn’s, of whom 58.3% were female, and 95.5% were white.
Physician’s global assessment scores were a mean of 7.5, and and 29% of patients were in remission before starting the treatment. After the first year on treatment, scores dropped to 3.9, with 68% of patients in remission, and after six years, scores were 3.3, with 75% of patients in remission, showing a significant improvement in disease outcomes.
Patients who had been diagnosed for a shorter period of time before starting the treatment showed better results. This had also been observed during the clinical trials.
Inflammatory bowel disease questionnaire scores improved from a mean of 40.72 before treatment to 51.72 after one year of therapy, and remained stable though six years. The mean work productivity and activity impairment (WPAI) questionnaire scores also showed clinically meaningful improvements that were sustained for the six-year period.
“This analysis of adalimumab-naïve patients with moderately to severely active Crohn’s disease enrolled in the PYRAMID registry demonstrated that improvements in disease activity, work productivity, and activity impairment in patients who remained in the study regardless of receiving adalimumab were achieved after 1 year in the registry and that these improvements were maintained through 6 years of the registry,” the authors wrote.
The treatment showed a safety profile similar to that reported in the clinical trials, with serious infections occurring in 11.2% of patients and severe adverse events possibly related to the treatment reported in 9.4%. The incidence of lymphoma and other cancers were low.
“Data from the PYRAMID registry support the known efficacy and safety profile of adalimumab in Crohn’s disease. Clinically meaningful improvements in disease activity, work productivity, and activity impairment were achieved in adalimumab-naïve patients with moderately to severely active Crohn’s disease and were maintained for up to 6 years. No new safety signals were observed,” the researchers concluded.
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