Alleviating flu-like symptoms with dose titration and analgesics in MS patients on intramuscular interferon beta-1a therapy: a pilot study.

Objective: To determine the effectiveness of dose titration and choice of analgesic in reducing flu-like side effects of intramuscular interferon beta-1a (i.m. IFNbeta-1a).

Methods: Patients were randomly assigned to receive weekly i.m. IFNbeta-1a, with or without dose titration, plus acetaminophen or ibuprofen. After 27 patients had been randomized, the original formulation of i.m. IFNbeta-1a became unavailable and the remaining patients used a pre-packaged liquid formulation, necessitating a change in protocol from initially quarter-dose to half-dose titration. Patients scored presence and intensity of muscle aches, chills, and weakness, and measured body temperature; information was recorded in diaries.

Results: Forty-seven patients were enrolled; 36 completed the study. Fifteen patients received full-dose therapy plus acetaminophen, eight patients received quarter-dose titration and acetaminophen, 10 patients received quarter-dose titration and ibuprofen, eight patients received half-dose titration and acetaminophen, and six patients received half-dose titration and ibuprofen. The mean number of acetaminophen doses taken was not statistically different from the mean number of ibuprofen doses taken per patient per week in any dose-titration group over measured time intervals (p > 0.05). Symptom scores from acetaminophen and ibuprofen dose-titration groups were combined and compared with the no-titration group. The proportion of patients with a mean increase of > or = 2 from baseline in flu-like symptom score trended lower in the titrated group compared with the no-titration group at 4 hours and 12-15 hours post-injection; these differences reached statistical significance only during the first 2 weeks of treatment (p = 0.015, quarter-dose vs. no titration).

Conclusion: This study supports the findings of previous studies demonstrating no difference in the effectiveness of acetaminophen and ibuprofen in controlling flu-like symptoms associated with IFNbeta treatment in patients with relapsing-remitting MS. Trends in this small pilot study suggest that the combination of initial dose titration and analgesic administration is useful for the reduction of flu-like symptoms with IFNbeta-1a therapy.