***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 Oral budesonide 9 mg/day represents first-line treatment of mild-to-moderately active ileocolonic Crohn 's disease . However , there is no precise recommendation for budesonide dosing due to lack of comparative data . A once-daily ( OD ) 9 mg dose may improve adherence and thereby efficacy . METHODS An eight-week , double-blind , double-dummy r and omised trial compared budesonide 9 mg OD versus 3 mg three-times daily ( TID ) in patients with mild-to-moderately active ileocolonic Crohn 's disease . Primary endpoint was clinical remission defined as CDAI < 150 at week 8 ( last observation carried forward ) . RESULTS The final intent-to-treat population comprised 471 patients ( 238 [ 9 mg OD ] , 233 [ 3 mg TID ] ) . The confirmatory population for the primary endpoint analysis was the interim per protocol population ( n=377 ; 188 [ 9 mg OD ] , 189 [ 3 mg TID ] ) , in which the primary endpoint was statistically non-inferior with budesonide 9 mg OD versus 3 mg TID . Clinical remission was achieved in 71.3 % versus 75.1 % , a difference of -3.9 % ( 95 % CI [ -14.6 % ; 6.4 % ] ; p=0.020 for non-inferiority ) . The mean ( SD ) time to remission was 21.9 ( 13.8 ) days versus 21.4 ( 14.6 ) days with budesonide 9 mg OD versus 3 mg TID , respectively . In a sub population of 122 patients with baseline SES-CD ulcer score ≥1  , complete mucosal healing occurred in 32.8 % ( 21/64 ) on 9 mg OD and 41.4 % ( 24/58 ) on 3 mg TID ; deep remission ( mucosal healing and clinical remission ) was observed in 26.6 % ( 17/64 ) and 32.8 % ( 19/58 ) of patients , respectively . Treatment-emergent suspected adverse drug reactions were reported in 4.6 % of 9 mg OD and 4.7 % of 3 mg TID patients . CONCLUSIONS Budesonide at the recommended dose of 9 mg/day can be administered OD without impaired efficacy and safety compared to 3 mg TID dosing in mild-to-moderately active Crohn 's disease BACKGROUND & AIMS Osteoporosis frequently occurs in Crohn 's disease , often because of corticosteroids . Budesonide as controlled release capsules is a locally acting corticosteroid with low systemic bioavailability . We investigated its effects on bone compared with prednisolone . METHODS In 34 international centers , 272 patients with Crohn 's disease involving ileum and /or colon ascendens were r and omized to once daily treatment with budesonide or prednisolone for 2 years at doses adapted to disease activity . One hundred eighty-one corticosteroid-free patients had active disease ( 98 had never received corticosteroids , corticosteroid naive ; 83 had received corticosteroids previously , corticosteroid exposed ) , and 90 had quiescent disease , receiving long-term low doses of corticosteroids , corticosteroid-dependent ; in 1 patient , no efficacy data were obtained . Bone mineral density and fractures were assessed in a double-blinded fashion ; disease activity , side effects , and quality of life were monitored . RESULTS Neither the corticosteroid-free nor the corticosteroid-dependent patients treated with budesonide differed significantly in bone mineral density from those receiving prednisolone . However , corticosteroid-naive patients receiving budesonide had smaller reductions in bone mineral density than those on prednisolone ( mean , -1.04 % vs -3.84 % ; P = .0084 ) . Treatment-emergent corticosteroid side effects were less frequent with budesonide .  Efficacy was similar in both groups . CONCLUSIONS Treatment with budesonide is associated with better preserved bone mass compared with prednisolone in only the corticosteroid-naive patients with active ileocecal Crohn 's disease . In both the corticosteroid-free and corticosteroid-dependent groups , budesonide and prednisolone were equally effective for up to 2 years , but budesonide caused fewer corticosteroid side effects BACKGROUND Budesonide is a steroid with low systemic effect and high effectiveness in the treatment of Crohn 's Disease ( CD ) . Beclomethasone dipropionate ( BDP ) is also a steroid with the same systemic effects , but it has been never investigated in CD . MATERIAL / METHODS To evaluate the effectiveness and tolerability of BDP versus budesonide in treating CD , we enrolled 30 consecutive patients affected by mild-to-moderate non-fistulizing , non-obstructive Crohn 's disease ( CDAI < or = 250 ) ( 13 M and 17 F , mean age : 33.4 years , range : 16 - 71 years ) in whom this diagnosis was made for the first time . The patients were r and omly treated for 8 weeks with budesonide 9 mg/day ( group A , 15 patients ) or with BDP 10 mg/day ( group B , 15 patients ) . RESULTS Of group A patients , 13/14 ( on intention to treat ( i-t-t ) : 86.67 % ) showed response to budesonide and 10/14 ( on i-t-t . : 66.66 % ) were in remission after 8 weeks of treatment . In group B patients , 10/14 ( on i-t-t : 66.66 % ) showed response to  BDP  and 8/14 ( on i-t-t : 53.33 % ) were in remission after 8 weeks of treatment ( p<0.001 ) . Budesonide was also faster in the time to obtain symptomatic remission ( p = n.s . ) and was better in improving IBDQL ( p<0.05 ) . Regarding side effects , two group A patients ( 6.66 % ) and three group B patients ( 10 % ) experienced mild-to-moderate side effects which were transitory and did not require any specific treatment or stopping the treatment . CONCLUSIONS BDP seems to be less effective than budesonide in treating CD , probably due to better the pharmacokinetic properties of budesonide Adalimumab is approved for use in patients with moderate to severe Crohn 's disease ( CD ) or ulcerative colitis ( UC ) who have not achieved disease control with conventional therapies including corticosteroids and /or immunomodulators ( IMM ) BACKGROUND & AIMS The aim of this study was to evaluate the usefulness of short-term infliximab combined with azathioprine ( AZA ) or 6-mercaptopurine ( 6-MP ) in steroid-dependent Crohn 's disease patients . METHODS Patients with active disease despite prednisone given for more than 6 months were eligible and were stratified as follows : the failure stratum consisted of patients receiving AZA/6-MP at a stable dose for more than 6 months , and the naive stratum consisted of patients not treated previously with AZA/6-MP . Patients were r and omized to infliximab 5 mg/kg or placebo at weeks 0 , 2 , and 6 . All patients were treated with AZA/6-MP maintained at a stable dose throughout the 52 weeks of the study . The primary end point was remission off steroids at week 24 . RESULTS Among the 113 enrolled patients ( 55 in the failure stratum ) , 57 were assigned to infliximab . At week 24 , the success rate ( intent-to-treat analysis ) was higher in the infliximab group than in the placebo group ( 57 % vs 29 % ; P = .003 ) ; at weeks 12 and 52 , the corresponding rates were 75 % vs 38 % ( P < .001 ) and 40 % vs 22 % ( P = .04 ) , respectively . In each stratum , the success rate was significantly higher in the infliximab group at weeks 12 and 24 , and a trend was found at week 52 . In the failure stratum , only 27 % of the patients in the infliximab group were still in remission off steroids , compared with 52 % in the naive stratum . Steroid resistance was less common and the cumulative dose of prednisone was lower in the infliximab group . CONCLUSIONS Infliximab plus AZA/6-MP is more effective than AZA/6-MP alone in steroid-dependent Crohn 's disease patients BACKGROUND TNF inhibitors have improved treatment of Crohn 's disease , ulcerative colitis , spondyloarthritis , rheumatoid arthritis , psoriatic arthritis , and chronic plaque psoriasis , but are expensive therapies . The aim of NOR-SWITCH was to examine switching from originator infliximab to the less expensive biosimilar CT-P13 regarding efficacy , safety , and immunogenicity . METHODS The study is a r and omised , non-inferiority , double-blind , phase 4 trial with 52 weeks of follow-up . Adult patients on stable treatment with infliximab originator treated in a hospital setting for at least 6 months were eligible for participation . Patients with informed consent were r and omised in a 1:1 ratio to either continued infliximab originator or to switch to CT-P13 treatment , with unchanged dosing regimen . Data were collected at infusion visits in 40 Norwegian study centres . Patients , assessors , and patient care providers were masked to treatment allocation . The primary endpoint was disease worsening during 52-week follow-up .  394 patients in the primary per- protocol set were needed to show a non-inferiority margin of 15 % , assuming 30 % disease worsening in each group . This trial is registered with Clinical Trials.gov , number NCT02148640 . FINDINGS Between Oct 24 , 2014 , and July 8 , 2015 , 482 patients were enrolled and r and omised ( 241 to infliximab originator , 241 to CT-P13 group ; one patient was excluded from the full analysis and safety set for CT-P13 ) and 408 were included in the per- protocol set ( 202 in the infliximab originator group and 206 in the CT-P13 group ) . 155 ( 32 % ) patients in the full analysis set had Crohn 's disease , 93 ( 19 % ) had ulcerative colitis , 91 ( 19 % ) had spondyloarthritis , 77 ( 16 % ) had rheumatoid arthritis , 30 ( 6 % ) had psoriatic arthritis , and 35 ( 7 % ) had chronic plaque psoriasis . Disease worsening occurred in 53 ( 26 % ) patients in the infliximab originator group and 61 ( 30 % ) patients in the CT-P13 group ( per- protocol set ; adjusted treatment difference -4·4 % , 95 % CI -12·7 to 3·9 ) . The frequency of adverse events was similar between groups ( for serious adverse events , 24 [ 10 % ] for infliximab originator vs 21 [ 9 % ] for CT-P13 ; for overall adverse events , 168 [ 70 % ] vs 164 [ 68 % ] ; and for adverse events leading to discontinuation , nine [ 4 % ] vs eight [ 3 % ] , respectively ) . INTERPRETATION The NOR-SWITCH trial showed that switching from infliximab originator to CT-P13 was not inferior to continued treatment with infliximab originator according to a prespecified non-inferiority margin of 15 % . The study was not powered to show non-inferiority in individual diseases . FUNDING Norwegian Ministry of Health and Care Services Background : Vedolizumab is a gut-selective & agr;4&bgr;7 integrin antagonist for the treatment of moderately to severely active Crohn 's disease ( CD ) . Aims of this study were to characterize the efficacy and safety of vedolizumab induction and maintenance therapy in patients who were naïve to tumor necrosis factor-alpha ( TNF-&agr ; ) antagonist therapy ( TNF-naïve ) or who had discontinued TNF-&agr ; antagonist therapy because of inadequate response ( i.e. , primary nonresponse ) , loss of response , or intolerance ( collectively classified as the TNF-failure population ) . Methods : Post hoc analyses of the efficacy data for 516 TNF-naïve and 960 TNF-failure patients from the GEMINI 2 and GEMINI 3 trials were evaluated at weeks 6 , 10 , and 52 and included clinical remission ( CD Activity Index [ CDAI ] score ⩽150 ) , enhanced clinical response ( ≥100-point decrease from baseline in CDAI score ) , durable clinical remission ( remission at ≥80 % of visits ) , and corticosteroid-free remission . Adverse events were summarized for the TNF-naïve and T 
    Output:
    
Corticosteroid therapies ( including budesonide ) can be used as induction , but not maintenance therapies .
Among immunosuppressants , thiopurines should not be used for induction , but can be used for maintenance therapy for selected low-risk patients .
Parenteral methotrexate was proposed for induction and maintenance therapy in patients with corticosteroid-dependent CD .
Biologic agents , including tumor necrosis factor antagonists , vedolizumab , and ustekinumab , were recommended for patients failed by conventional induction therapies and as maintenance therapy .
The consensus group was unable to clearly define the role of concomitant immunosuppressant therapies in initiation of treatment with a biologic agent .