human
***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 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND & AIMS Tumor necrosis factor blockade has been shown to be an effective treatment strategy in Crohn 's disease ( CD ) . Adalimumab is a human immunoglobulin G1 ( IgG(1 ) ) monoclonal antibody targeting tumor necrosis factor ( TNF ) . A r and omized , double-blind , placebo-controlled , dose-ranging trial was performed to evaluate the efficacy of adalimumab induction therapy in patients with CD . METHODS A total of 299 patients with moderate to severe CD naive to anti-TNF therapy  were r and omized to receive subcutaneous injections at weeks 0 and 2 with adalimumab 40 mg/20 mg , 80 mg/40 mg , or 160 mg/80 mg or placebo . The primary endpoint was demonstration of a significant difference in the rates of remission at week 4 ( defined as a Crohn 's Disease Activity Index score < 150 points ) among the 80 mg/40 mg , 160 mg/80 mg , and placebo groups . RESULTS The rates of remission at week 4 in the adalimumab 40 mg/20 mg , 80 mg/40 mg , and 160 mg/80 mg groups were 18 % ( P = .36 ) , 24 % ( P = .06 ) , and 36 % ( P = .001 ) , respectively , and 12 % in the placebo group . Adverse events occurred at similar frequencies in all 4 treatment groups except injection site reactions , which were more common in adalimumab-treated patients . CONCLUSIONS Adalimumab was superior to placebo for induction of remission in patients with moderate to severe Crohn 's disease naive to anti-TNF therapy . The optimal induction dosing regimen for adalimumab in this study was 160 mg at week 0 followed by 80 mg at week 2 . Adalimumab was well tolerated BACKGROUND Studies in animals and an open-label trial have suggested a role for antibodies to tumor necrosis factor alpha , specifically chimeric monoclonal antibody cA2 , in the treatment of Crohn 's disease . METHODS We conducted a 12-week multicenter , double-blind , placebo-controlled trial of cA2 in 108 patients with moderate-to-severe Crohn 's disease that was resistant to treatment . All had scores on the Crohn 's Disease Activity Index between 220 and 400 ( scores can range from 0 to about 600 , with higher scores indicating more severe illness ) . Patients were r and omly assigned to receive a single two-hour intravenous infusion of either placebo or cA2 in a dose of 5 mg per kilogram of body weight , 10 mg per kilogram , or 20 mg per kilogram . Clinical response , the primary end point , was defined as a reduction of 70 or more points in the score on the Crohn 's Disease Activity Index at four weeks that was not accompanied by a change in any concomitant medications . RESULTS At four weeks , 81 percent of the patients given 5 mg of cA2 per kilogram ( 22 of 27 patients ) , 50 percent of those given 10 mg of cA2 per kilogram ( 14 of 28 ) , and 64 percent of those given 20 mg of cA2 per kilogram ( 18 of 28 ) had had a clinical response , as compared with 17 percent of patients in the placebo group ( 4 of 24 ) ( p<0.001 for the comparison of the cA2 group as a whole with placebo ) . Thirty-three percent of the patients given cA2 went into remission ( defined as a score below 150 on the Crohn 's Disease Activity Index ) , as compared with 4 percent of the patients given placebo ( P=0.005 ) . At 12 weeks , 41 percent of the cA2-treated patients ( 34 of 83 ) had had a clinical response , as compared with 12 percent of the patients in the placebo group ( 3 of 25 ) ( P=0.008 ) . The rates of adverse effects were similar in the groups . CONCLUSIONS A single infusion of cA2 was an effective short-term treatment in many patients with moderate-to-severe , treatment-resistant Crohn 's disease Needing a single index of degree of illness in Crohn 's disease , the National Cooperative Crohn 's Disease Study group collected data prospect ively from 187 visits of 112 patients with Crohn 's disease of the small bowel , colon , or both . Information on 18 predictor variables was gathered at each visit . In addition , the attending physician rated his over-all evaluation of how well the patient was doing and compared the patient 's status with that at the previous visit . A multiple regression computer program was utilized to derive an equation for prediction of the physician 's over-all ratings from a subset of the predictor variables fulfilling a combination of constraints . This equation , numerically simplified and utilizing eight selected variables , is the Crohn 's Disease Activity Index . Index values of 150 and below are associated with quiescent disease ; values above that indicate active disease , and values above 450 are seen with extremely severe disease Clinical and laboratory observations of 133 children and adolescents with Crohn 's disease were used to vali date an index of severity of illness previously developed by a group of senior pediatric gastroenterologists at a research forum in April 1990 . This pediatric Crohn 's disease activity index ( PCDAI ) included ( a ) subjective reporting of the degree of abdominal pain , stool pattern , and general well-being ; ( b ) presence of extraintestinal manifestations , such as fever , arthritis , rash , and uveitis ; ( c ) physical examination findings ; ( d ) weight and height ; and ( e ) hematocrit , erythrocyte sedimentation rate , and serum albumin . Independent evaluation of each patient by two physician-observers was performed at the time of a visit , and each physician completed a PCDAI index and a modified Harvey-Bradshaw index and made a " global assessment " of disease activity as none , mild , moderate , or severe . Excellent interobserver agreement was noted for the PCDAI , modified Harvey-Bradshaw index , and global assessment . There was a strong correlation between global assessment and both the PCDAI or modified Harvey-Bradshaw . Increasing PCDAI scores were noted with increasing disease severity , and significant differences in scores were noted between the severity groups . We propose that the PCDAI could be used in multicenter projects to facilitate patient stratification by disease severity and that longitudinal PCDAI scores might provide a numerical measure of response to therapeutic regimens BACKGROUND Certolizumab pegol is a pegylated humanized Fab ' fragment that binds tumor necrosis factor alpha . METHODS In a r and omized , double-blind , placebo-controlled trial , we evaluated the efficacy of certolizumab pegol in 662 adults with moderate-to-severe Crohn 's disease . Patients were stratified according to baseline levels of C-reactive protein ( CRP ) and were r and omly assigned to receive either 400 mg of certolizumab pegol or placebo subcutaneously at weeks 0 , 2 , and 4 and then every 4 weeks . Primary end points were the induction of a response at week 6 and a response at both weeks 6 and 26 . RESULTS Among patients with a baseline CRP level of at least 10 mg per liter , 37 % of patients in the certolizumab group had a response at week 6 , as compared with 26 % in the placebo group ( P=0.04 ) . At both weeks 6 and 26 , the corresponding values were 22 % and 12 % , respectively ( P=0.05 ) . In the overall population , response rates at week 6 were 35 % in the certolizumab group and 27 % in the placebo group ( P=0.02 ) ; at both weeks 6 and 26 , the response rates were 23 % and 16 % , respectively ( P=0.02 ) . At weeks 6 and 26 , the rates of remission in the two groups did not differ significantly ( P=0.17 ) . Serious adverse events were reported in 10 % of patients in the certolizumab group and 7 % of those in the placebo group ; serious infections were reported in 2 % and less than 1 % , respectively . In the certolizumab group , antibodies to the drug developed in 8 % of patients , and antinuclear antibodies developed in 2 % . CONCLUSIONS In patients with moderate-to-severe Crohn 's disease , induction and maintenance therapy with certolizumab pegol was associated with a modest improvement in response rates , as compared with placebo , but with no significant improvement in remission rates . ( Clinical Trials.gov number , NCT00152490 [ Clinical Trials.gov ] . ) 
    Output:
    
agent
***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 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND & AIMS Tumor necrosis factor blockade has been shown to be an effective treatment strategy in Crohn 's disease ( CD ) . Adalimumab is a human immunoglobulin G1 ( IgG(1 ) ) monoclonal antibody targeting tumor necrosis factor ( TNF ) . A r and omized , double-blind , placebo-controlled , dose-ranging trial was performed to evaluate the efficacy of adalimumab induction therapy in patients with CD . METHODS A total of 299 patients with moderate to severe CD naive to anti-TNF therapy  were r and omized to receive subcutaneous injections at weeks 0 and 2 with adalimumab 40 mg/20 mg , 80 mg/40 mg , or 160 mg/80 mg or placebo . The primary endpoint was demonstration of a significant difference in the rates of remission at week 4 ( defined as a Crohn 's Disease Activity Index score < 150 points ) among the 80 mg/40 mg , 160 mg/80 mg , and placebo groups . RESULTS The rates of remission at week 4 in the adalimumab 40 mg/20 mg , 80 mg/40 mg , and 160 mg/80 mg groups were 18 % ( P = .36 ) , 24 % ( P = .06 ) , and 36 % ( P = .001 ) , respectively , and 12 % in the placebo group . Adverse events occurred at similar frequencies in all 4 treatment groups except injection site reactions , which were more common in adalimumab-treated patients . CONCLUSIONS Adalimumab was superior to placebo for induction of remission in patients with moderate to severe Crohn 's disease naive to anti-TNF therapy . The optimal induction dosing regimen for adalimumab in this study was 160 mg at week 0 followed by 80 mg at week 2 . Adalimumab was well tolerated BACKGROUND Studies in animals and an open-label trial have suggested a role for antibodies to tumor necrosis factor alpha , specifically chimeric monoclonal antibody cA2 , in the treatment of Crohn 's disease . METHODS We conducted a 12-week multicenter , double-blind , placebo-controlled trial of cA2 in 108 patients with moderate-to-severe Crohn 's disease that was resistant to treatment . All had scores on the Crohn 's Disease Activity Index between 220 and 400 ( scores can range from 0 to about 600 , with higher scores indicating more severe illness ) . Patients were r and omly assigned to receive a single two-hour intravenous infusion of either placebo or cA2 in a dose of 5 mg per kilogram of body weight , 10 mg per kilogram , or 20 mg per kilogram . Clinical response , the primary end point , was defined as a reduction of 70 or more points in the score on the Crohn 's Disease Activity Index at four weeks that was not accompanied by a change in any concomitant medications . RESULTS At four weeks , 81 percent of the patients given 5 mg of cA2 per kilogram ( 22 of 27 patients ) , 50 percent of those given 10 mg of cA2 per kilogram ( 14 of 28 ) , and 64 percent of those given 20 mg of cA2 per kilogram ( 18 of 28 ) had had a clinical response , as compared with 17 percent of patients in the placebo group ( 4 of 24 ) ( p<0.001 for the comparison of the cA2 group as a whole with placebo ) . Thirty-three percent of the patients given cA2 went into remission ( defined as a score below 150 on the Crohn 's Disease Activity Index ) , as compared with 4 percent of the patients given placebo ( P=0.005 ) . At 12 weeks , 41 percent of the cA2-treated patients ( 34 of 83 ) had had a clinical response , as compared with 12 percent of the patients in the placebo group ( 3 of 25 ) ( P=0.008 ) . The rates of adverse effects were similar in the groups . CONCLUSIONS A single infusion of cA2 was an effective short-term treatment in many patients with moderate-to-severe , treatment-resistant Crohn 's disease Needing a single index of degree of illness in Crohn 's disease , the National Cooperative Crohn 's Disease Study group collected data prospect ively from 187 visits of 112 patients with Crohn 's disease of the small bowel , colon , or both . Information on 18 predictor variables was gathered at each visit . In addition , the attending physician rated his over-all evaluation of how well the patient was doing and compared the patient 's status with that at the previous visit . A multiple regression computer program was utilized to derive an equation for prediction of the physician 's over-all ratings from a subset of the predictor variables fulfilling a combination of constraints . This equation , numerically simplified and utilizing eight selected variables , is the Crohn 's Disease Activity Index . Index values of 150 and below are associated with quiescent disease ; values above that indicate active disease , and values above 450 are seen with extremely severe disease Clinical and laboratory observations of 133 children and adolescents with Crohn 's disease were used to vali date an index of severity of illness previously developed by a group of senior pediatric gastroenterologists at a research forum in April 1990 . This pediatric Crohn 's disease activity index ( PCDAI ) included ( a ) subjective reporting of the degree of abdominal pain , stool pattern , and general well-being ; ( b ) presence of extraintestinal manifestations , such as fever , arthritis , rash , and uveitis ; ( c ) physical examination findings ; ( d ) weight and height ; and ( e ) hematocrit , erythrocyte sedimentation rate , and serum albumin . Independent evaluation of each patient by two physician-observers was performed at the time of a visit , and each physician completed a PCDAI index and a modified Harvey-Bradshaw index and made a " global assessment " of disease activity as none , mild , moderate , or severe . Excellent interobserver agreement was noted for the PCDAI , modified Harvey-Bradshaw index , and global assessment . There was a strong correlation between global assessment and both the PCDAI or modified Harvey-Bradshaw . Increasing PCDAI scores were noted with increasing disease severity , and significant differences in scores were noted between the severity groups . We propose that the PCDAI could be used in multicenter projects to facilitate patient stratification by disease severity and that longitudinal PCDAI scores might provide a numerical measure of response to therapeutic regimens BACKGROUND Certolizumab pegol is a pegylated humanized Fab ' fragment that binds tumor necrosis factor alpha . METHODS In a r and omized , double-blind , placebo-controlled trial , we evaluated the efficacy of certolizumab pegol in 662 adults with moderate-to-severe Crohn 's disease . Patients were stratified according to baseline levels of C-reactive protein ( CRP ) and were r and omly assigned to receive either 400 mg of certolizumab pegol or placebo subcutaneously at weeks 0 , 2 , and 4 and then every 4 weeks . Primary end points were the induction of a response at week 6 and a response at both weeks 6 and 26 . RESULTS Among patients with a baseline CRP level of at least 10 mg per liter , 37 % of patients in the certolizumab group had a response at week 6 , as compared with 26 % in the placebo group ( P=0.04 ) . At both weeks 6 and 26 , the corresponding values were 22 % and 12 % , respectively ( P=0.05 ) . In the overall population , response rates at week 6 were 35 % in the certolizumab group and 27 % in the placebo group ( P=0.02 ) ; at both weeks 6 and 26 , the response rates were 23 % and 16 % , respectively ( P=0.02 ) . At weeks 6 and 26 , the rates of remission in the two groups did not differ significantly ( P=0.17 ) . Serious adverse events were reported in 10 % of patients in the certolizumab group and 7 % of those in the placebo group ; serious infections were reported in 2 % and less than 1 % , respectively . In the certolizumab group , antibodies to the drug developed in 8 % of patients , and antinuclear antibodies developed in 2 % . CONCLUSIONS In patients with moderate-to-severe Crohn 's disease , induction and maintenance therapy with certolizumab pegol was associated with a modest improvement in response rates , as compared with placebo , but with no significant improvement in remission rates . ( Clinical Trials.gov number , NCT00152490 [ Clinical Trials.gov ] . ) 
    Output:
    