TOUCH® PRO Study: The Impact of Natalizumab on Utilization of Healthcare Resources by the Patients and Their Associated Treatment Satisfaction

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-α. The study sample was comprised of patients enrolled in the TYSABRI Outreach: Unified Commitment to Health (TOUCH®) prescribing program that were apprised of the project and agreed to study participation. CD patients completed online or phone surveys regarding their prior biologic history, steroid use, complications over the past 3 months and healthcare utilization. Patients also completed the Treatment Satisfaction Questionnaire for Medicines (TSQM) which measures their satisfaction with treatment effectiveness, side-effects and convenience, and global treatment satisfaction. Data were collected prior to the initiation of NAT therapy and at month 3 of treatment. To date, 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. Ninety-two percent of the patients reported prior biologic use, 87% had used infliximab; 66% had used adalimumab and 21% had used certolizumab. Overall, 23% of patients had used one anti-TNF, while 56% had used 2 anti-TNFs and 13% had used all 3 anti-TNFs. Sixty-five percent of patients reported steroid use in the past 3 months prior to baseline, and during this same time, the mean number of hospital admissions was 0.8, mean days in hospital was 6.4, the mean number of emergency room (ER) visits due to CD was 1.3, and mean days of total parenteral nutrition was 6.3. Among the 24 patients providing month 3 data, there was a significant decrease in the number of CD-related ER visits (1.3 vs. 0.7, P = 0.032) and the percent of patients with CD-related complications (abscess, fistula, ostomy, obstruction (50% vs. 41%)). Significant improvements were observed in each of the four scales of the TSQM at follow-up (Effectiveness Scale 28.6 vs. 63.0, P < 0.001; Side-effects Scale 61.6 vs. 82.2, P = 0.01, Convenience Scale 63.8 vs. 70.8, P = 0.05; Global Satisfaction Scale 41.3 vs. 67.0, P < 0.001). CD patients who have failed conventional therapy and at least one anti-TNF therapy report substantial resource utilization in a three month period of time. Although there are limitations due to patient drop-out, the followup from many of these patients demonstrates significant improvement, suggesting the ability of NAT to reduce resource utilization. Further study of patient subtypes most likely to benefit in this manner is warranted.

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