A randomized open label study of pain medications (naproxen, acetaminophen and ibuprofen) for controlling side effects during initiation of IFN β-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis

Abstract

Multiple sclerosis (MS) patients initiating IFN beta-1a, Avonex, therapy (Group 1, n = 30) or experiencing side effects after 6 months on therapy (Group 2, n = 30) were randomized for 5 weeks open label adjunct therapy to naproxen (Aleve), acetaminophen (Tylenol) or ibuprofen (Advil). Our hypothesis was that non-prescription pain medications are effective in decreasing or alleviating the side effects associated with IFN beta-1a therapy. Contrary to the hypothesis, most patients in both groups continued to report side effects on all pain medications. After 5 weeks, headache, fever, chills and injection site pain were low in< or = 50% of patients. Moderate to significant fatigue, muscle or joint pain continued in most patients. As a quality of life measure, the Modified Fatigue Impact Scale (mFIS) improved for Group 1 on naproxen or ibuprofen with greatest improvement in physical subset (P = 0.002 for naproxen and P<0.01 for ibuprofen). Total mFIS for Group 1 on acetaminophen improved (P = 0.04) due to improved cognitive subset rather than physical subset. Group 2, with side effects initially, reported less significant fatigue (severity 5-10) but more moderate fatigue (severity 2-4) at study end for all three medications. All medications improved cognitive subset (P = 0.05). Physical mFIS subset did not improve for Group 2 on acetaminophen, but did with naproxen (P = 0.05) or ibuprofen (P = 0.03). Naproxen and ibuprofen were more effective than acetaminophen in minimizing physical side effects of IFN beta-1a. None of the three pain medications tested were as effective as hypothesized for minimizing fatigue or muscle and joint pain.

Nurses’ Perspective on Approaches to Limit Flu-Like Symptoms During Interferon Therapy for Multiple Sclerosis

“…The panel reviewed three studies 25,27,28 that attempted to determine the most effective analgesic for FLS management. When the efficacies of acetaminophen, ibuprofen, and the steroid prednisone were compared, no significant difference was found between the treatment options in the first month of therapy with IM IFNβ-1a.…”

“…27 Similarly, Reess et al 25 compared acetaminophen and ibuprofen and found them equally effective at FLS management in patients initiating IM IFNβ-1a. Leuschen et al 28 compared the efficacy of naproxen, ibuprofen, and acetaminophen and found that the first two were more effective than the last at minimizing many of the physical symptoms associated with IM IFNβ-1a. However, none of these therapies was as effective as originally hypothesized of FLS at the 4-to 6-hour time point and at the 12-to 15-hour time point was significantly reduced with both 3-week titration (P < .001 at 4-6 hours; P = .006 at 12-15 hours) and 6-week titration (P = .023 at 4-6 hours; P = .027 at 12-15 hours).…”

“…Maintenance of adequate hydration is particularly important in patients who inject during the evening, as restricting fluid intake for minimizing fatigue or for effectively managing joint and muscle pain. 28 Based on these studies, the panel recommended that patients take ibuprofen or naproxen 1 hour prior to IM IFNβ-1a injection, as both compounds were shown to be better than acetaminophen at providing overall prophylaxis of FLS. In one clinical trial a course of steroids with acetaminophen significantly reduced FLS compared to acetaminophen alone; however, patients taking steroids should be carefully monitored, and steroids should generally not be used for long-term symptom management.…”

NUB1 suppression of Huntington toxicity: mechanistic insights

“…20 Further testing of the effect of IFNβ treatment in the in vivo HD animal models using methods such as intraperitoneal injection 42 may serve as a proof of concept of potential NUB1-mediated therapy. Given the many side effects of IFNβ, [44][45][46] low-molecular-weight compounds that are easier to deliver or less toxic are more desired compared to IFNβ. Finding such compounds could be achieved by screening for transcriptional enhancers of NUB1 by minigene assays.…”

Pathogenesis and Progression of Multiple Sclerosis: The Role of Arachidonic Acid–Mediated Neuroinflammation

“…To date, NSAIDs have been administered to patients to treat flu-like symptoms without taking into consideration of their potential role in oligodendrocytes survival and myelin protection (41)(42)(43)(44)(45)(46). Nevertheless, some NSAIDs were shown to ameliorate fatigue (approximate percentage of improvement: 10-20% with aspirin, 30% with naproxen, and 20% with ibuprofen) and improve cognitive abilities (approximate fold change of improvement: 1-fold with naproxen, 0.5-fold with ibuprofen, and 2-fold with acetaminophen) (46,47). It could be hypothesized that these effects may be secondary to the attenuation of brain pathology due to NSAIDs treatment, as suggested by the following data from experimental models of multiple sclerosis.…”