Putting Data to Work to Answer Questions: Evaluation of Adalimumab Effectiveness in Anti-Tumor Necrosis Factor-Naïve Pediatric Patients with Crohn’s Disease in Clinical Practice

The ImproveCareNow Registry is a treasure trove of information about patients living with IBD. But, data, like Amazon gift cards, are worthless unless used. And it takes some intrepid, or at least good-with-numbers, Indiana Jones-type researchers to plunge into the depths of the jumble of figures – to put the data to work to answer questions.

Such an expedition was launched by Steve Steiner and a team of clinical researchers from across ICN. Their goal was to answer to a simple question: Just how well does adalimumab (Humira) work as initial anti-TNF (i.e., biologic) therapy for pediatric patients with Crohn’s disease?  While there are clinical trial data demonstrating the drug’s effectiveness - leading to the FDA’s approval in 2014 of adalimumab for children and adolescents (e.g., IMAgINE 1 and IMAgINE 2 studies) – these studies included not only patients new to adalimumab but also those who had prior experience with another anti-TNF therapy, infliximab (Remicade), muddying the waters when it comes to assessing the medication as a first-line anti-TNF therapy. Also, findings from research studies do not always reflect real-world experiences with a medication, so looking at the clinical response to treatment with adalimumab in pediatric patients starting an anti-TNF medication can provide a more realistic assessment of its performance.

The ICN researchers conducted a retrospective analysis, meaning they looked back through existing data to answer their question. Using the ICN registry, they reviewed the period from 2010 through 2015, to see what happened to children and adolescents with Crohn’s disease who were started on anti-TNF therapy with adalimumab first as part of routine care provided at 43 ICN centers in the United States. Of greatest interest were the rates of remission over time, defined by the Physician Global Assessment and Short Pediatric Crohn’s Disease Activity Index measures, as well as steroid–free (e.g., prednisone) remission rates. In addition, the team examined how long patients remained on adalimumab.

At the ICN centers, a total of 174 children and adolescents were treated with adalimumab as their first anti-TNF therapy and had at least one follow-up clinic visit. The mean age at the time of Crohn’s disease diagnosis was 13 years and, on average, they started adalimumab at 14.5 years of age. Some patients had more recently started the medication, so not all the 174 contributed data at every one of the time periods looked at (for example, a child started on adalimumab in mid-2015 would have less follow-up data than another child who began the medication in 2011).

Here is what the team discovered:

• At 3 months after adalimumab was started, all 174 were still on the medication, and 69-71% were in steroid-free remission
• At 6 months after adalimumab was started, of the 174 who had a clinic visit, 95% were still on the medication, and 75-77% were in steroid-free remission
• At 12 months after adalimumab was started, of the 154 who had a clinic visit, 94% were still on the medication, and 79-80% were in steroid-free remission
• At 24 months after adalimumab was started, of the 71 who had a clinic visit, 97% were still on the medication, and 91-94% were in steroid-free remission
• At 36 months after adalimumab was started, of the 39 who had a clinic visit, 80-86% were still on the medication, and 81-86% were in steroid-free remission

Therefore, overall a very high percentage of those started on adalimumab were still on the medication at each of the time points, plus the vast majority of them were in remission based on the clinical assessments used.

The study also explored whether concomitant immunomodulator therapy (e.g., adding a second medication such as: azathioprine, 6-mecaptopurine, methotrexate) had any impact on remission (about half of those who started on adalimumab were also on an immunomodulator). No positive or negative effect on remission was seen with concomitant immunomodulator therapy. However, the number of patients studied during the retrospective analysis is too small to detect all but the greatest impact of this approach.

This research study is notable for a few reasons. Foremost, the real-world response to adalimumab reported was fabulous and is a signal that this medication may be a reasonable initial anti-TNF therapy for patients with Crohn’s disease. Infliximab (Remicade) was the first anti-TNF to be approved to treat pediatric Crohn’s disease, so it is prescribed much more often than adalimumab. Had adalimumab been available first, it would likely be the go-to initial anti-TNF medication for Crohn’s disease in patients. The fact that adalimumab can be given at home by injection, rather than by infusion in a facility, punctuates the importance of further study of this medication as first-line anti-TNF therapy.  Additionally, this analysis demonstrates not only the power of the data, but also the people who have been joined together across the ImproveCareNow Network. The collaborations that ICN supports and encourages allow for important questions to be asked of the data by smart people – including researchers, clinicians (physicians, nurses, and students), patients, and parents. Together these teams can search for something more precious to patients living with IBD than any jewel or ancient artifact – knowledge.

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