Humira (adalimumab) is a biological therapy that the U.S. Food and Drug Administration approved for treating inflammatory bowel disease, or IBD. It is manufactured by AbbVie, formerly part of Abbot Laboratories.
It is approved for both types of IBD, Crohn’s disease and ulcerative colitis in adults, and for Crohn’s in children. It is also prescribed for rheumatoid arthritis, polyarticular juvenile arthritis, psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa.
How Humira works
In IBD, the immune system begins to mistakenly target healthy body tissue in the gastrointestinal tract and cause damage. Results can include swelling — or inflammation — and ulcers. The cause of the disease is unknown. The more scientists understand about the immune system, the more they are able to develop therapies that target facets of it.
Humira is an antibody, or protein designed to interact with a specific target. It works by blocking the action of a cytokine called tumor necrosis factor alpha, or TNFa. Immune cells produce TNFa, a protein that affects inflammatory response, as part of the normal immune response process. In IBD, levels of TNFa are increased, contributing to an inflammatory response that can be damaging.
By inhibiting TNF, Humira can not only alleviate symptoms of IBD, but also push the condition into remission — that is, a state of no symptoms. It can also keep the condition under control for a long time, or in what is called sustained remission.
Humira in clinical trials
Humira has been extensively tested in humans. There have been more than 500 clinical trials, many of them in Crohn’s and ulcerative colitis.
In February 2007, the FDA approved it as a treatment for moderate to severe Crohn’s after conventional treatments fail. The approval was based on three key clinical trials: CLASSIC I, CHARM (NCT00077779), and GAIN (NCT00105300). Researchers used the Crohn’s disease activity index (CDAI) to measure response to Humira.
The CLASSIC I and GAIN trials looked at patients’ response after four weeks. In both, a significantly higher number of patients who took Humira achieved remission compared with a placebo. The figures in CLASSIC I were 36 percent in the Humira group versus 12 percent in the placebo group. In GAIN, the figures were 21 percent and 7 percent.
Over half of the patients responded to Humira, with the yardstick being a reduction of at least 70 points in their CDAI score by the end of the four weeks. In addition, more than half had a significant reduction in Crohn’s symptoms.
The CHARM trial compared patients’ response to Humira versus a placebo over 56 weeks. The results, published in the journal Gastroenterology, showed that a significantly higher number of Crohn’s patients responded to treatment after 26 weeks, or entered remission after 56 weeks, than the placebo group.
In September 2012, the FDA approved Humira as a treatment for ulcerative colitis after therapies such as corticosteroids have failed. The approval was based on the findings of the ULTRA clinical trials, which demonstrated the safety and effectiveness of Humira over four years.
Researchers used patients’ Mayo and inflammatory bowel disease questionnaire (IBDQ) scores, along with measures such as mucosal healing, to calculate a remission rate. The results, published in Nature, showed that Humira significantly outperformed a placebo in putting colitis into remission. Remission occurred as early as eight weeks in some patients.
In September 2014, the FDA approved Humira for treating children ages 6 and older with Crohn’s. It based its authorization on the results of the Phase 3 IMAgINE-1 clinical trial (NCT00409682).
The results showed that Humira did a significantly better job than a placebo of putting the children’s Crohn’s into remission and keeping it in remission. By week 26 of the trial, 34 percent had achieved remission. The children also tolerated the treatment well.
A 240-week follow-up trial (NCT00686374) called IMAgINE-2 demonstrated that Humira was safe and effective over the long term. The results were published in the journal Inflammatory Bowel Diseases.
A Phase 3 clinical trial (NCT02065557) assessing Humira’s safety and effectiveness against colitis in children ages 4 to 17 is recruiting participants.
Other information
Humira is administered as an injection under the skin.
Common side effects include injection-site reactions, sinus infections, headaches, rash, and nausea. In rare cases, Humira can have serious adverse effects, including the development of infections such as tuberculosis, allergic reactions, psoriasis, nervous system problems, liver problems, heart failure, blood problems, and cancer.
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