In the Journals

Humira safe, effective in Crohn’s through 6 years

Edward Loftus
Edward Loftus

Humira therapy helped improve both clinical and patient-reported Crohn’s disease outcomes for up to 6 years, according to study results published in Inflammatory Bowel Diseases.

Edward V. Loftus Jr., MD, of the Mayo Clinic in Rochester, Minnesota, and Chief Medical Editor of Healio Gastroenterology and Liver Disease, and colleagues analyzed data taken from the PYRAMID registry, an international, postmarketing registry that assessed long-term safety and effectiveness of Humira (adalimumab, AbbVie).

“For many of the biologics we prescribe, the FDA has mandated safety registries to track potential adverse events of therapies,” Loftus told Healio Gastroenterology and Liver Disease. “This paper was focused on effectiveness of adalimumab among the registry patients who were naive to adalimumab at baseline.”

In their analysis, researchers found that 2,057 adult patients with CD experienced improvement with several outcomes.

Patients had a mean Physician’s Global Assessment (a combination of Harvey Bradshaw Index [HBI] and rectal bleeding score) improvement from 7.5 at baseline to 3.9 at year 1 and 3.3 at year 6. The proportion of patients in clinical remission (defined as an HBI score less than 5) increased from 29% at baseline to 68% at year 1 and 75% at year 6. Patients who were taking immunomodulators at baseline had similar HBI rates, while patients with shorter disease duration had higher remission rates.

In terms of patient-reported outcomes, investigators found that scores in the Short Inflammatory Bowel Disease Questionnaire and Work Productivity and Activity Index (WPAI) improved at year 1. All improvements in WPAI subscores were clinically meaningful (at least 7% point change) at year 1 and were maintained through year 6.

Reports of serious infections were found in 11.1% of patients, while rates of malignancies, lymphoma and demyelinating disorders were low. Researchers observed no new safety signals.

“This study showed that adalimumab improved disease activity, work productivity and activity impairment, especially in those Crohn’s disease patients who stayed on drug,” Loftus said. “These improvements appeared to be independent of concomitant immunomodulator use. Patients with shorter disease duration had numerically higher improvements but this wasn’t statistically significant.” – by Alex Young

Disclosures: Loftus has received consulting fees from AbbVie, Allergan, Amgen, Celgene, Celltrion Healthcare, Eli Lilly, Janssen, Napo Pharmaceuticals, Pfizer, Takeda, and UCB. He has also received research support from AbbVie, Amgen, Celgene, Genentech, Gilead, Janssen, MedImmune, Robarts Clinical Trials, Seres Therapeutics, Takeda, and UCB. Please see the full study for all other authors’ relevant financial disclosures.

Edward Loftus
Edward Loftus

Humira therapy helped improve both clinical and patient-reported Crohn’s disease outcomes for up to 6 years, according to study results published in Inflammatory Bowel Diseases.

Edward V. Loftus Jr., MD, of the Mayo Clinic in Rochester, Minnesota, and Chief Medical Editor of Healio Gastroenterology and Liver Disease, and colleagues analyzed data taken from the PYRAMID registry, an international, postmarketing registry that assessed long-term safety and effectiveness of Humira (adalimumab, AbbVie).

“For many of the biologics we prescribe, the FDA has mandated safety registries to track potential adverse events of therapies,” Loftus told Healio Gastroenterology and Liver Disease. “This paper was focused on effectiveness of adalimumab among the registry patients who were naive to adalimumab at baseline.”

In their analysis, researchers found that 2,057 adult patients with CD experienced improvement with several outcomes.

Patients had a mean Physician’s Global Assessment (a combination of Harvey Bradshaw Index [HBI] and rectal bleeding score) improvement from 7.5 at baseline to 3.9 at year 1 and 3.3 at year 6. The proportion of patients in clinical remission (defined as an HBI score less than 5) increased from 29% at baseline to 68% at year 1 and 75% at year 6. Patients who were taking immunomodulators at baseline had similar HBI rates, while patients with shorter disease duration had higher remission rates.

In terms of patient-reported outcomes, investigators found that scores in the Short Inflammatory Bowel Disease Questionnaire and Work Productivity and Activity Index (WPAI) improved at year 1. All improvements in WPAI subscores were clinically meaningful (at least 7% point change) at year 1 and were maintained through year 6.

Reports of serious infections were found in 11.1% of patients, while rates of malignancies, lymphoma and demyelinating disorders were low. Researchers observed no new safety signals.

“This study showed that adalimumab improved disease activity, work productivity and activity impairment, especially in those Crohn’s disease patients who stayed on drug,” Loftus said. “These improvements appeared to be independent of concomitant immunomodulator use. Patients with shorter disease duration had numerically higher improvements but this wasn’t statistically significant.” – by Alex Young

Disclosures: Loftus has received consulting fees from AbbVie, Allergan, Amgen, Celgene, Celltrion Healthcare, Eli Lilly, Janssen, Napo Pharmaceuticals, Pfizer, Takeda, and UCB. He has also received research support from AbbVie, Amgen, Celgene, Genentech, Gilead, Janssen, MedImmune, Robarts Clinical Trials, Seres Therapeutics, Takeda, and UCB. Please see the full study for all other authors’ relevant financial disclosures.