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50 20 mg weekly, single or divided doses
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20 50 mg weekly; 1 day a week dosing 15 2 mg/kg/d,; single am dose
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1 g/m2 4 6 mg/d; single am dose 4 6 mg/kg/d, split into two daily doses
Daily to weekly blood count and urinalysis Monthly blood count and liver enzymes Blood pressure, monthly cyclosporine level, creatinine/BUN, and liver enzymes Blood counts are performed weekly 1 month, twice monthly for the second and third month, and once a month for the rst year Heart rate, blood pressure, and creatinine/BUN
Mycophenolate mofetil
Adults (1 g BID to 15 g BID) Children (600 mg/m2 / dose BID) (no more than 1 g/d in patients with renal failure) 2 g/kg over 2 5 d; then every 4 8 weeks as needed
Intravenous immunoglobulin
Modi ed with permission from Amato AA, Barohn RJ Idiopathic in ammatory myopathies Neurol Clin 1997;15:615 648
or lower serum CK levels were de ned as positive responses rather than the more important objective improvement in muscle strength and function42,199 There are only a few published prospective, double-blinded, placebo-controlled trials in the treatment of PM,82,200 DM,201 and IBM202 207 Nevertheless, there has been a trend in recent years to perform more rigorous studies Despite the paucity of prospective, double-blinded, placebo-controlled trials, it is clear to experienced clinicians that various modes of immunotherapy are helpful
in DM and PM in improving muscle strength and function In contrast, IBM is generally refractory to immunosuppressive therapy
Prednisone is our and PM1,15,82 In initiate treatment Solumedrol (1 g rst-line treatment of choice for DM patients with severe weakness, we with a short course of intravenous daily for 3 days) prior to starting
oral agents High-dose prednisone appears to reduce morbidity and improve muscle strength and function21,42,66,67,208 Retrospective series report that 58 100% of patients with DM at least partially improve, while 30 66% respond completely with prednisone2,42 Over 80% of patients with PM at least partially improve, but only 10 33% completely respond to prednisone2,42 Noticeable clinical improvement begins within 3 6 months of starting prednisone in most patients with DM or PM2,21 When no response is noted after an adequate trial of high-dose prednisone, other alternative diagnoses (eg, IBM or an in ammatory muscular dystrophy) and repeat muscle biopsy should be considered Others and we have found minimal, if any, clinically signi cant improvement in strength of function with prednisone or other second-line agents in patients with IBM2,4,82,94,106,209 However, a few retrospective, unblinded studies reported mild or transient improvement with prednisone42,199 A partial response to prednisone was noted in 40 58% of patients with IBM, although none had complete return of strength Careful review of these retrospective, unblinded studies shows that the investigators considered subjective improvement or lower serum CK levels with treatment a positive response No demonstration of objective improvement in muscle strength was evident These same investigators performed a small (11 patients) unblinded, prospective, cross-over designed study comparing prednisone plus azathioprine plus oral methotrexate with prednisone plus intravenous methotrexate199 There was no clinically signi cant change in strength over the 6-month treatment period in both study arms, although they found that the serum CK levels decreased in 66 70% of the patients On this basis, the investigators concluded that the combination of immunosuppressive medications stabilized the disease process As IBM is slowly progressive and the study was neither unblinded nor placebo controlled, any assertion of treatment ef cacy would be premature after a trial of only 6 months duration In patients with DM, PM, presumed autoimmune necrotizing myopathy, and other idiopathic in ammatory myositides other than IBM (ie, sarcoidosis), we initiate treatment with single-dose prednisone (15 mg/kg up to 100 mg) every morning15,82 After 2 4 weeks of daily prednisone, we switch directly to alternate-day dosing (ie, 100 mg every other day) Patients with more severe disease may need to be slowly tapered to alternate-day dosing over 2 3 months (eg, decrease alternate dose by 10 mg every week until they are on 100 mg every other day) Patients are followed initially at least every 2 4 weeks We maintain the high-dose prednisone until patients are back to normal strength or until improvement in strength has reached a plateau (usually 4 6 months) Subsequently, we slowly taper the prednisone by 5 mg every 2 3 weeks Once the dose is reduced to 20 mg every other day, we taper prednisone no faster than 25 mg every 2 weeks
We add on the second-line agents (methotrexate, azathioprine, mycophenolate, or IVIG) in patients who do not signi cantly improve after 4 6 months of prednisone, or if there is an exacerbation during the taper15,82 In patients who relapse during the taper, we double the dose of prednisone and return to daily treatment (no more than 100 mg/d) for at least 2 weeks before switching back to every other day dosing Once a patient has regained their strength, we resume the prednisone taper at a slower rate We monitor the serum CK levels; however, adjustments of prednisone and other immunosuppressive agents should be based on the objective clinical examination and not the CK levels or the patients subjective response Serum CKs can be elevated in patients with no objective weakness or can be normal or only mildly elevated in patients with active disease An increasing serum CK can herald a relapse, but, without objective clinical deterioration, we would not increase the dose of the immunosuppressive agent However, we may hold the dose or the slow the taper A maintenance dose of prednisone may be required to sustain the clinical response Some authorities advocate initiating and maintaining treatment with daily prednisone rather than switching to alternate-day therapy and splitting the daily dose of prednisone (eg, three times a day) instead of consolidating the prednisone into a single morning dose210 We have found no advantage in splitting the dose of prednisone or maintaining daily dosing We feel that alternate-day dosing of prednisone is as effective and is associated with less side effects than daily prednisone in most patients211 However, daily dosing of prednisone is often necessary in patients with diabetes due to marked uctuation in glucose control with alternate-day therapy and those few patients who do not have a good response to alternate-day regimen Relapse of the myositis needs to be distinguished from steroid myopathy This quandary may occur in patients who initially improved but then start developing progressive muscle weakness following long-term corticosteroid treatment because it can cause type 2 muscle ber atrophy Features that would suggest a steroid myopathy as opposed to relapse of myositis would be a normal serum CK, and absense of muscle membrance irritability on EMG In contrast, patients who become weaker during prednisone taper, have increasing serum CK levels, and abnormal spontaneous activity on EMG are more likely experiencing a are of the myositis
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