***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    ***EXAMPLES*** 
    Input: BACKGROUND The therapeutic options for patients with polymyositis or dermatomyositis that is resistant to corticosteroids are limited , unproved , and often toxic . Uncontrolled trials concluded that both plasma exchange and leukapheresis are beneficial , but despite the considerable use of these approaches , proof of their efficacy is lacking . METHODS Thirty-nine patients with definite polymyositis or dermatomyositis were r and omly assigned to receive plasma exchange ( replacement of one volume of plasma with 5 percent albumin in saline ) , leukapheresis ( removal of 5 x 10(9 ) to 10 x 10(9 ) lymphocytes ) , or sham apheresis in a double-blind manner , with 12 treatments given over a one-month period . Muscle strength , functional capacity , and serum levels of muscle-associated enzymes were measured before and after the 12 procedures . RESULTS In each group 3 of 13 patients had improvements in strength and functional capacity . The condition of 3 patients treated with leukapheresis and 1 treated with plasma exchange deteriorated , and it was unchanged in the other 26 patients . Adverse effects of apheresis included the need for a central venous catheter ( 9 patients ) , major vasovagal episodes ( 3 patients ) , and severe citrate reactions ( 2 patients ) . Despite the occurrence of significant reductions in the serum levels of muscle enzymes with plasma exchange ( P less than 0.001 ) and significant decreases in lymphocyte counts with leukapheresis ( P = 0.002 ) , there were no significant differences among the three treatment groups in the final muscle strength or functional capacity of the patients . CONCLUSIONS As treatments for corticosteroid-resistant polymyositis or dermatomyositis , leukapheresis and plasma exchange are no more effective than sham apheresis BACKGROUND Dermatomyositis is a clinical ly distinct myopathy characterized by rash and a complement-mediated microangiopathy that results in the destruction of muscle fibers . In some patients the condition becomes resistant to therapy and causes severe physical disabilities . METHODS We conducted a double-blind , placebo-controlled study of 15 patients ( age , 18 to 55 years ) with biopsy-proved , treatment-resistant dermatomyositis . The patients continued to receive prednisone ( mean daily dose , 25 mg ) and were r and omly assigned to receive one infusion of immune globulin ( 2 g per kilogram of body weight ) or placebo per month for three months , with the option of crossing over to the alternative therapy for three more months . Clinical response was gauged by assessing muscle strength , neuromuscular symptoms , and changes in the rash . Changes in immune-mediated muscle abnormalities were determined by repeated muscle biopsies . RESULTS The eight patients assigned to immune globulin had a significant improvement in sores of muscle strength ( P < 0.018 ) and neuromuscular symptoms ( P < 0.035 ) , whereas the seven patients assigned to placebo did not . With crossovers a total of 12 patients received immune globulin . Of these , nine with severe disabilities had a major improvement to nearly normal function . Their mean muscle-strength scores increased from 74.5 to 84.7 , and their neuromuscular symptoms improved . Two of the other three patients had mild improvement , and one had no change in his condition . Of 11 placebo-treated patients , none had a major improvement , 3 had mild improvement , 3 had no change in their condition , and 5 had worsening of their condition . Repeated biopsies in five patients of muscles whose strength improved to almost normal showed an increase in muscle-fiber diameter ( P < 0.04 ) , an increase in the number and a decrease in the diameter of capillaries ( P < 0.01 ) , resolution of complement deposits on capillaries , and a reduction in the expression of intercellular adhesion molecule 1 and major-histocompatibility-complex class I antigens . CONCLUSIONS High-dose intravenous immune globulin is a safe and effective treatment for refractory dermatomyositis High-dose intravenous immunoglobulin ( IVIG ) therapy has been effective in treating various autoimmune and systemic inflammatory diseases . Here , we assessed the efficacy and safety of IVIG therapy with polyethylene glycol-treated human IgG ( drug code GB-0998 ) for patients with corticosteroid-refractory polymyositis ( PM ) and dermatomyositis ( DM ) by means of a r and omized , double-blind , placebo-controlled study . We r and omly assigned 26 subjects ( 16 PM and 10 DM ) to receive either GB-0998 or placebo . Intragroup comparison in the GB-0998 group showed statistically significant improvements due to GB-0998 administration in the primary endpoint ( manual muscle test score ) and secondary endpoints ( serum creatine kinase level and activities of daily living score ) . However , significant improvements were also found in the placebo group , and comparison of the GB-0998 group with the placebo group did not show any significant difference between the groups . We discuss possible reasons for the absence of a clear intergroup difference in efficacy . Nineteen adverse drug reactions were observed in 11 of 26 subjects ( 42.3 % ) , of which 2 events ( decreased muscle strength and increased serum creatine kinase ) were assessed as serious ; however , they are previously known events . These results indicate that GB-0998 can be safely used with the same pre caution s as other current IVIG therapy Objective . Ciclosporin and MTX are used in idiopathic inflammatory myopathies ( DM and PM ) when patients incompletely respond to glucocorticoids . Their effectiveness is unproved in r and omized controlled trials ( RCTs ) . We evaluated their benefits in a placebo-controlled factorial RCT . Methods . A 56-week multicentre factorial- design double-blind placebo-controlled RCT compared steroids alone , MTX ( 15–25 mg weekly ) plus steroids , ciclosporin ( 1–5 mg/kg/day ) plus steroids and all three treatments . It enrolled adults with myositis ( by Bohan and Peter criteria ) with active disease receiving corticosteroids . Results . A total of 359 patients were screened and 58 r and omized . Of the latter , 37 patients completed 12 months of treatment , 7 were lost to follow-up and 14 discontinued treatment . Patients completing 12 months of treatment showed significant improvement ( P < 0.001 on paired t-tests ) in manual muscle testing ( 14 % change ) , walking time ( 22 % change ) and function ( 9 % change ) . Intention to treat and completer analyses indicated that ciclosporin monotherapy , MTX monotherapy and ciclosporin/MTX combination therapy showed no significant treatment effects in comparison with placebo . Conclusion . Neither MTX nor ciclosporin ( by themselves or in combination ) improved clinical features in myositis patients who had incompletely responded to glucocorticoids . Trial Registration : International St and ard R and omized Controlled Trial Number Register ; http://www.controlled-trials.com/ ; IS RCT OBJECTIVES To test the utility of a new , easy to administer instrument for assessing activities of daily living in patients with amyotrophic lateral sclerosis ( ALS ) , to vali date its accuracy , and to assess its ability to record disease progression in patients with ALS against other functional scales , quantitative isometric muscle testing , and global assessment scales . DESIGN Serial assessment s of patients who presented to four ALS treatment centers in two multicenter studies . PATIENTS Study 1 ( cross-sectional ) evaluated 75 consecutive patients who presented to four ALS treatment centers during a 2-month period . Study 2 ( longitudinal ) evaluated the progression of 53 patients who were enrolled in a multicenter , phase I-II clinical trial of recombinant human ciliary neurotrophic factor for treatment of ALS . OUTCOME MEASURES The ALS Functional Rating Scale ( ALSFRS ) was compared with quantitative myometry and with other measures of daily function in patients with ALS both cross-sectionally and longitudinally . RESULTS The first study of 75 patients evaluated the internal consistency , the test-retest reliability , and the construct validity of the ALSFRS . Internal consistency and test-retest reliability were high . Patient self-rating of upper- and lower-extremity-dependent tasks were highly correlated with measures of upper- and lower-extremity strength , respectively . Thus , the ALSFRS has good construct validity . In the second study , ALSFRS scores declined in t and em with deterioration in motor and pulmonary function , indicating its sensitivity to change . CONCLUSIONS The ALSFRS is a useful instrument for evaluation of functional status and functional change in patients with ALS . Its results are in close agreement with objective measures of muscle strength and pulmonary function . The ALSFRS may be used as a screening measure for entry into clinical trials , as a surrogate measure of function in situations in which muscle strength can not be measured directly , or as an adjunct to myometry To determine if high-dose pulsed dexamethasone is more effective and safer than daily high-dose prednisolone in treatment-naive adult patients with inflammatory myopathies ( sporadic inclusion body myositis excluded ) we performed a multicenter , double-blind r and omised controlled clinical trial with 18 months follow-up . Sixty-two patients were r and omised into 28-day cycles of oral high-dose dexamethasone or daily high-dose prednisolone . Primary outcome measures included ( 1 ) seven point composite score of six clinical ly relevant outcomes and ( 2 ) ( time-to ) remission and ( time-to ) relapse . No difference between both treatment groups on the composite score was found . Side-effects occurred significantly less frequently in the dexamethasone group . Median time to relapse was 60 ( 2.9 ) weeks in the prednisolone and 44 ( 4.7 ) weeks in the dexamethasone group ( log-rank test p=0.03 ) . In conclusion , pulsed high-dose oral dexamethasone is not superior to daily prednisolone as first-line treatment of idiopathic inflammatory myopathies , but is a good alternative by causing substantially fewer side-effects Two groups of patients with polymyositis have been followed for approximately 3 years . One group was treated with prednisone alone and the other with prednisone plus azathioprine . Although the polymyositis of both groups has improved , no statistically significant difference was noted at the end of 3 months , as previously reported . Longer followup , however , has shown that the group given prednisone plus azathioprine has improved more with respect to functional disability ; this group also requires less prednisone for disease control A controlled , prospect i ve , double-blind , therapeutic trial of azathioprine was conducted in the initial therapy of polymyositis . Sixteen patients received 60 mg prednisone per day plus either azathioprine ( 2 mg/kg of body weight per day ) or placebo for a period of 3 months .  Creatine phosphokinase ( CPK ) levels fell to normal slightly sooner in the placebo group , but not significantly so . The azathioprine group did not become significantly stronger ( P = 0.58 ) and did not manifest significantly greater improvement of histopathologic features of muscle ( P = 0.80 ) than the placebo group . Initial CPK elevations were significantly related to the degree of muscle inflammation ( P = 0.037 ) , but this was not the case at 3 months ( P greater than 0.05 ) . Normalization of the CPK could not be equated with disease control . Type II fiber atrophy , attributed to steroid therapy , was more marked in women than in men ( P less than 0.03 ) OBJECTIVE To assess the safety and efficacy of rituximab in a r and omized , double-blind , placebo-phase trial in adult and pediatric myositis patients . METHODS Adults with refractory polymyositis ( PM ) and adults and children with refractory dermatomyositis ( DM ) were enrolled . Entry criteria included muscle weakness and ≥2 additional abnormal values on core set measures ( CSMs ) for adults . Juvenile DM patients required ≥3 abnormal CSMs , with or without muscle weakness . Patients were r and omized to receive either rituximab early or rituximab late , and glucocorticoid or immunosuppressive therapy was allowed at study entry . The primary end point compared the time to achieve the International Myositis Assessment and Clinical Studies Group preliminary definition of improvement ( DOI ) between the 2 groups . The secondary end points were the time to achieve ≥20 % improvement in muscle strength and the proportions of patients in the early and late rituximab groups achieving the DOI at week 8 . RESULTS Among 200 r and omized patients ( 76 with PM , 76 with DM , and 48 with juvenile DM ) , 195 showed no difference in the time to achieving the DOI between the rituximab late ( n = 102 ) and rituximab early ( n = 93 ) groups ( P = 0.74 by log rank test ) , with a median time to achieving a DOI of 20.2 weeks and 20.0 weeks , respectively . The secondary end points also did not significantly differ between the 2 treatment groups . However , 161 ( 83 % ) of the r and omized patients met the DOI , and individual CSMs improved in both groups throughout the 44-week trial . CONCLUSION Although there were no significant differences in the 2 treatment arms for the primary and secondary end points , 83 % of adult 
    Output:
    
Although no treatment can be recommended on the basis of this review , improved outcomes were demonstrated with a number of agents including methotrexate , azathioprine , ciclosporin , rituximab , and intravenous immunoglobulin .
Plasmapheresis and leukapheresis were of no apparent benefit .