TOUCH® Patient Reported Outcomes Study: The Impact of Natalizumab on Crohnʼs Disease Severity

Abstract

BACKGROUND: Natalizumab (NAT) is an integrin receptor antagonist indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha. METHODS: The study sample was comprised of patients enrolled in the TYSABRI Outreach: Unified Commitment to Health (TOUCHV ) prescribing program that were apprised of the project and agreed to study participation. Patients completed online or phone surveys regarding demographic characteristics, CD history and CD severity as defined by ACG Practice Guidelines (Lichtenstein GR, Hanauer SB, Sandborn WJ. Management of Crohn's disease in adults: ACG practice guidelines. Am J Gastroenterol. 2009;104:465-483) and measured by patient selfreports based on disease status descriptors and the patient reported components of the Harvey-Bradshaw index (HBI). Data were collected prior to the initiation of NAT therapy and at month 3 of treatment. RESULTS: At the end of the study, 61 patients have provided baseline data. Females comprised 61% of the sample, with a mean age of 42 years and mean time from diagnosis of 13 years. CD complications had been experienced by a high percentage of the patients (66% fistula, 54% bowel obstruction, 52% abscess) and 25% reported having had an ostomy. Seventy-percent of patients who were administered the hospital anxiety and depression scale were diagnosed with depression and anxiety. Of the 24 patients that have completed the 3- month follow-up, 83.3% identified their disease severity as moderate to severe at baseline. At the month 3 measure, 41.7% rated their disease status as moderate to severe (P = 0.001). Significant reductions in disease severity were also seen across the 2 patient reported components of the HBI (mean well-being 2.0 vs. 1.0, P = 0.01; mean abdominal pain 2.0 vs. 1.0, P = 0.001; and mean number of liquid stools 14.9 vs. 13.7). The patients reported experiencing a mean of 6.8 CD relapses in the 3 months prior to treatment initiation vs. 4.0 in the 3 months after (P = 0.004). CONCLUSION(S): The demographics of the sample appear to be consistent with product labeling pointing to patients who have moderate to severe CD despite attempts at control through the use of conventional and anti-TNF therapies. The disease history of patients entering into therapy with NAT in this naturalistic study indicates a high percentage of patients with CD complications and concomitant psychiatric disturbances. Among patients who completed a follow- up interview, there was significant improvement in disease activity. However, it is not possible to know the true response rate as patients who did not complete the follow-up survey may have been more likely to be nonresponders.