NeuroTalk Support Groups - Evaluation of Topical Tx for Site Reactions

From the Ectrims site:

http://www.akm.ch/ectrims2006/

Evaluation of topical interventions in the reduction of injection-site reactions after interferon treatment for multiple sclerosis

D. Mikol for the ASSIST Study Group

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Background: Injection-site reactions (ISRs) are common in treatment with injected multiple sclerosis (MS) therapies. Although ISRs are typically mild, the risks associated with decreased adherence are important, as it is essential to maintain continuous active treatment to reduce inflammatory activity and ultimately slow disease progression.

Based on anecdotal evidence, over-the-counter (OTC) topical anti-inflammatory agents are often recommended to treat ISRs, but their efficacy has not been studied in well-controlled clinical trials.

Objective: To evaluate three OTC topical medications’ abilities to reduce ISRs in patients with relapsing-remitting MS treated with Rebif (registered trademark [r]) (interferon-beta-1a sc, tiw).

Design: This study planned to enroll 100 subjects with an interim analysis to assess patients that completed the study. Two independent, 9-week, multicentre, open-label, crossover studies were designed to compare Cortizone-10(r) (hydrocortisone) and Tucks(r) Pads (witch hazel) to Lubriderm(r) Lotion, which served as a control.

Patients with ISRs (defined as redness at least 20 mm in diameter 48-72 hours (h) post-injection) were randomly assigned to apply a test agent or Lubriderm(r) immediately post-injection for 2 weeks. Participants then switched from control to test agent or vice versa for the final 2 weeks. ISRs were measured 48-72 h and 7 days (d) post-injection. The primary outcome measure was the difference in the mean diameter of redness 48-72 h post-injection.

Results: At interim analysis (03/2006), 29 of 100 expected subjects had completed the study. Subjects were typically female (88.9%) and Caucasian (94.4%), with a mean age of 41.4 years. In the hydrocortisone/Lubriderm(r) cross-over study, average baseline diameter of injection-site redness was 37.4 mm (n = 27).

For the 22 evaluable patients, mean redness diameter at 48-72 h post-injection was 34.8 mm (standard deviation, 14.8) with hydrocortisone; 33.0 mm (10.8) with Lubriderm(r) (P = 0.55). After 7 d, respective diameters were 31.7 mm (16.3) and 31.0 mm (12.7; P = 0.89).

Although fewer patients in the witch hazel/Lubriderm(r) study were evaluable at interim, results were similar, with a slight trend toward both agents reducing redness.

Conclusions: A final analysis of data from the hydrocortisone study will be presented along with interim data from the witch hazel study. Successful reduction of ISRs may ultimately improve patient adherence to interferon-beta therapy.