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{userid:"meyer_eye", "articletype":"article","pages":"511-513","author":"F Alten, C H Meyer","year":"2011","title":"[Sudden unilateral loss of vision under high-dosage corticosteroid therapy for pansinusitis].","month":"May","journal":"HNO","publisher":"","volume":"59","number":"5","note":"","tags":"Adrenal Cortex Hormones,Anti-Inflammatory Agents,Blindness,Female,Humans,Middle Aged,Sinusitis","booktitle":"","editor":"","abstract":"Endogenous and exogenous glucocorticoids are suspected to play a key role in the development of central serous chorioretinopathy (CSC), which is characterized by a serous detachment of the neurosensory retina caused by the accumulation of fluid between the retinal pigment epithelium and the photoreceptor layer. We report the case of a patient with pansinusitis who was treated with high-dose corticosteroids and developed CSC. Patients under systemic corticosteroid therapy should be informed about the associated risk and symptoms of CSC.","address":"","school":"","issn":"1433-0458","doi":"10.1007\/s00106-010-2221-8","isi":"","pubmed":"21181393","key":"Alten2011","howpublished":"","urllink":"","refid":184}
,

{userid:"meyer_eye", "refid":"210","repocollections":"","attachment":"","_thumb":"","articletype":"article","sectionheading":"","title":"Release and velocity of micronized dexamethasone implants with an intravitreal drug delivery system: kinematic analysis with a high-speed camera.\r\n","year":"2012","author":"Meyer CH, Klein A, Alten F, Liu Z, Stanzel BV, Helb HM, Brinkmann CK.\r\n","journal":"Retina","volume":"32","number":"10","pages":"2133-40","month":"","doi":"10.1097\/IAE.0b013e31825699e5","pubmed":"23060033 ","pdflink":"","urllink":"","abstract":"","note":"","tags":"","weight":"210"}
,

{userid:"sdingel", "articletype":"article","pages":"204-10","author":"F Buttgereit, D Mehta, J Kirwan, J Szechinski, M Boers, R E Alten, J Supronik, I Szombati, U Romer, S Witte, K G Saag","year":"2013","title":"Low-dose prednisone chronotherapy for rheumatoid arthritis : a randomised clinical trial (CAPRA-2)","month":"","journal":"Ann Rheum Dis","publisher":"","volume":"72","number":"2","note":"Buttgereit, Frank ;Mehta, Daksha ;Kirwan, John ;Szechinski, Jacek ;Boers, Maarten ;Alten, Rieke E ;Supronik, Jerzy ;Szombati, Istvan ;Romer, Ulrike ;Witte, Stephan ;Saag, Kenneth G ;England ;Ann Rheum Dis. 2013 Feb;72(2):204-10. doi: 10.1136\/annrheumdis-2011-201067. Epub 2012 May 5.","tags":"2013,Feld E, intern,Website","booktitle":"","editor":"","abstract":"OBJECTIVE: To assess the efficacy and safety of low-dose prednisone chronotherapy using a new modified-release (MR) formulation for the treatment of rheumatoid arthritis (RA). METHODS: In this 12-week, double-blind, placebo-controlled study, patients with active RA (n=350) were randomised 2:1 to receive MR prednisone 5 mg or placebo once daily in the evening in addition to their existing RA disease-modifying antirheumatic drug (DMARD) treatment. The primary end point was the percentage of patients achieving a 20% improvement in RA signs and symptoms according to American College of Rheumatology criteria (ie, an ACR20 response) at week 12. Changes in morning pain, duration of morning stiffness, 28-joint Disease Activity Score and health-related quality of life were also assessed. RESULTS: MR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, p<0.001) and ACR50 (22% vs 10%, p<0.006) and a greater median relative reduction from baseline in morning stiffness (55% vs 35%, p<0.002) at week 12 than placebo plus DMARD treatment. Significantly greater reductions in severity of RA (Disease Activity Score 28) (p<0.001) and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue score) (p=0.003) as well as a greater improvement in physical function (36-item Short-Form Health Survey score) (p<0.001) were seen at week 12 for MR prednisone versus placebo. The incidence of adverse events was similar for MR prednisone (43%) and placebo (49%). CONCLUSION: Low-dose MR prednisone added to existing DMARD treatment produced rapid and relevant improvements in RA signs and symptoms. CLINICALTRIALS.GOV, NUMBER: NCT00650078.","address":"","school":"","issn":"1468-2060 (Electronic) ;0003-4967 (Linking)","doi":"10.1136\/annrheumdis-2011-201067","isi":"","pubmed":"","key":"Buttgereit2013","howpublished":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22562974","urllink":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22562974","refid":67886,"weight":67886}
,

{userid:"Sekretariat", "articletype":"article","pages":"204-10","author":"F Buttgereit, D Mehta, J Kirwan, J Szechinski, M Boers, R E Alten, J Supronik, I Szombati, U Romer, S Witte, K G Saag","year":"2013","title":"Low-dose prednisone chronotherapy for rheumatoid arthritis : a randomised clinical trial (CAPRA-2)","month":"","journal":"Ann Rheum Dis","publisher":"","volume":"72","number":"2","note":"Buttgereit, Frank xD;Mehta, Daksha xD;Kirwan, John xD;Szechinski, Jacek xD;Boers, Maarten xD;Alten, Rieke E xD;Supronik, Jerzy xD;Szombati, Istvan xD;Romer, Ulrike xD;Witte, Stephan xD;Saag, Kenneth G xD;England xD;Ann Rheum Dis. 2013 Feb;72(2):204-10. doi: 10.1136\/annrheumdis-2011-201067. Epub 2012 May 5.","tags":"2013,Feld E, intern,Website","booktitle":"","editor":"","abstract":"OBJECTIVE: To assess the efficacy and safety of low-dose prednisone chronotherapy using a new modified-release (MR) formulation for the treatment of rheumatoid arthritis (RA). METHODS: In this 12-week, double-blind, placebo-controlled study, patients with active RA (n=350) were randomised 2:1 to receive MR prednisone 5 mg or placebo once daily in the evening in addition to their existing RA disease-modifying antirheumatic drug (DMARD) treatment. The primary end point was the percentage of patients achieving a 20% improvement in RA signs and symptoms according to American College of Rheumatology criteria (ie, an ACR20 response) at week 12. Changes in morning pain, duration of morning stiffness, 28-joint Disease Activity Score and health-related quality of life were also assessed. RESULTS: MR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, p<0.001) and ACR50 (22% vs 10%, p<0.006) and a greater median relative reduction from baseline in morning stiffness (55% vs 35%, p<0.002) at week 12 than placebo plus DMARD treatment. Significantly greater reductions in severity of RA (Disease Activity Score 28) (p<0.001) and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue score) (p=0.003) as well as a greater improvement in physical function (36-item Short-Form Health Survey score) (p<0.001) were seen at week 12 for MR prednisone versus placebo. The incidence of adverse events was similar for MR prednisone (43%) and placebo (49%). CONCLUSION: Low-dose MR prednisone added to existing DMARD treatment produced rapid and relevant improvements in RA signs and symptoms. CLINICALTRIALS.GOV, NUMBER: NCT00650078.","address":"","school":"","issn":"","doi":"10.1136\/annrheumdis-2011-201067","isi":"","pubmed":"","key":"Buttgereit2013","howpublished":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22562974","urllink":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22562974","refid":11848,"weight":11848}
,

{userid:"Sekretariat", "articletype":"article","pages":"204-10","author":"F Buttgereit, D Mehta, J Kirwan, J Szechinski, M Boers, R E Alten, J Supronik, I Szombati, U Romer, S Witte, K G Saag","year":"2013","title":"Low-dose prednisone chronotherapy for rheumatoid arthritis : a randomised clinical trial (CAPRA-2)","month":"","journal":"Ann Rheum Dis","publisher":"","volume":"72","number":"2","note":"Buttgereit, Frank xD;Mehta, Daksha xD;Kirwan, John xD;Szechinski, Jacek xD;Boers, Maarten xD;Alten, Rieke E xD;Supronik, Jerzy xD;Szombati, Istvan xD;Romer, Ulrike xD;Witte, Stephan xD;Saag, Kenneth G xD;England xD;Ann Rheum Dis. 2013 Feb;72(2):204-10. doi: 10.1136\/annrheumdis-2011-201067. Epub 2012 May 5.","tags":"2013,Feld E, intern,Website","booktitle":"","editor":"","abstract":"OBJECTIVE: To assess the efficacy and safety of low-dose prednisone chronotherapy using a new modified-release (MR) formulation for the treatment of rheumatoid arthritis (RA). METHODS: In this 12-week, double-blind, placebo-controlled study, patients with active RA (n=350) were randomised 2:1 to receive MR prednisone 5 mg or placebo once daily in the evening in addition to their existing RA disease-modifying antirheumatic drug (DMARD) treatment. The primary end point was the percentage of patients achieving a 20% improvement in RA signs and symptoms according to American College of Rheumatology criteria (ie, an ACR20 response) at week 12. Changes in morning pain, duration of morning stiffness, 28-joint Disease Activity Score and health-related quality of life were also assessed. RESULTS: MR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, p<0.001) and ACR50 (22% vs 10%, p<0.006) and a greater median relative reduction from baseline in morning stiffness (55% vs 35%, p<0.002) at week 12 than placebo plus DMARD treatment. Significantly greater reductions in severity of RA (Disease Activity Score 28) (p<0.001) and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue score) (p=0.003) as well as a greater improvement in physical function (36-item Short-Form Health Survey score) (p<0.001) were seen at week 12 for MR prednisone versus placebo. The incidence of adverse events was similar for MR prednisone (43%) and placebo (49%). CONCLUSION: Low-dose MR prednisone added to existing DMARD treatment produced rapid and relevant improvements in RA signs and symptoms. CLINICALTRIALS.GOV, NUMBER: NCT00650078.","address":"","school":"","issn":"","doi":"10.1136\/annrheumdis-2011-201067","isi":"","pubmed":"","key":"Buttgereit2013","howpublished":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22562974","urllink":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22562974","refid":13626,"weight":13626}
,

{userid:"Sekretariat", "articletype":"article","pages":"204-10","author":"F Buttgereit, D Mehta, J Kirwan, J Szechinski, M Boers, R E Alten, J Supronik, I Szombati, U Romer, S Witte, K G Saag","year":"2013","title":"Low-dose prednisone chronotherapy for rheumatoid arthritis : a randomised clinical trial (CAPRA-2)","month":"","journal":"Ann Rheum Dis","publisher":"","volume":"72","number":"2","note":"Buttgereit, Frank  ;Mehta, Daksha  ;Kirwan, John  ;Szechinski, Jacek  ;Boers, Maarten  ;Alten, Rieke E  ;Supronik, Jerzy  ;Szombati, Istvan  ;Romer, Ulrike  ;Witte, Stephan  ;Saag, Kenneth G  ;England  ;Ann Rheum Dis. 2013 Feb;72(2):204-10. doi: 10.1136\/annrheumdis-2011-201067. Epub 2012 May 5.","tags":"2013,Feld E, intern,Website","booktitle":"","editor":"","abstract":"OBJECTIVE: To assess the efficacy and safety of low-dose prednisone chronotherapy using a new modified-release (MR) formulation for the treatment of rheumatoid arthritis (RA). METHODS: In this 12-week, double-blind, placebo-controlled study, patients with active RA (n=350) were randomised 2:1 to receive MR prednisone 5 mg or placebo once daily in the evening in addition to their existing RA disease-modifying antirheumatic drug (DMARD) treatment. The primary end point was the percentage of patients achieving a 20% improvement in RA signs and symptoms according to American College of Rheumatology criteria (ie, an ACR20 response) at week 12. Changes in morning pain, duration of morning stiffness, 28-joint Disease Activity Score and health-related quality of life were also assessed. RESULTS: MR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, p<0.001) and ACR50 (22% vs 10%, p<0.006) and a greater median relative reduction from baseline in morning stiffness (55% vs 35%, p<0.002) at week 12 than placebo plus DMARD treatment. Significantly greater reductions in severity of RA (Disease Activity Score 28) (p<0.001) and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue score) (p=0.003) as well as a greater improvement in physical function (36-item Short-Form Health Survey score) (p<0.001) were seen at week 12 for MR prednisone versus placebo. The incidence of adverse events was similar for MR prednisone (43%) and placebo (49%). CONCLUSION: Low-dose MR prednisone added to existing DMARD treatment produced rapid and relevant improvements in RA signs and symptoms. CLINICALTRIALS.GOV, NUMBER: NCT00650078.","address":"","school":"","issn":"1468-2060 (Electronic)  ;0003-4967 (Linking)","doi":"10.1136\/annrheumdis-2011-201067","isi":"","pubmed":"","key":"Buttgereit2013","howpublished":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22562974","urllink":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22562974","refid":15404,"weight":15404}
,

{userid:"sdingel", "articletype":"article","pages":"","author":"J Detert, H Bastian, J Listing, A Weiss, S Wassenberg, A Liebhaber, K Rockwitz, R Alten, K Kruger, R Rau, C Simon, E Gremmelsbacher, T Braun, B Marsmann, V Hohne-Zimmer, K Egerer, F Buttgereit, G R Burmester","year":"2012","title":"Induction therapy with adalimumab plus methotrexate for 24 weeks followed by methotrexate monotherapy up to week 48 versus methotrexate therapy alone for DMARD-naive patients with early rheumatoid arthritis : HIT HARD, an investigator-initiated study","month":"","journal":"Ann Rheum Dis","publisher":"","volume":"","number":"","note":"Detert, Jacqueline ;Bastian, Hans ;Listing, Joachim ;Weiss, Anja ;Wassenberg, Siegfried ;Liebhaber, Anke ;Rockwitz, Karin ;Alten, Rieke ;Kruger, Klaus ;Rau, Rolf ;Simon, Christina ;Gremmelsbacher, Eva ;Braun, Tanja ;Marsmann, Bettina ;Hohne-Zimmer, Vera ;Egerer, Karl ;Buttgereit, Frank ;Burmester, Gerd-R ;Ann Rheum Dis. 2012 Jul 10.","tags":"2012,Feld E, intern,Website,Feld C, extern","booktitle":"","editor":"","abstract":"OBJECTIVE: To investigate the long-term effects of induction therapy with adalimumab (ADA) plus methotrexate (MTX) in comparison with placebo (PBO) plus MTX in DMARD-naive patients with active early rheumatoid arthritis (RA). METHODS: Patients with active early RA (disease duration of <\/=12 months) were randomly assigned to receive 40 mg ADA subcutaneously every other week (eow) plus MTX 15 mg\/week subcutaneously or PBO plus MTX subcutaneously at 15 mg\/week over 24 weeks. Thereafter, all patients received MTX monotherapy up to week 48. The primary outcome was the Disease Activity Score 28 (DAS28) at week 48. Secondary outcomes included proportions of patients in remission (DAS28<2.6), ACR responses, Health Assessment Questionnaire (HAQ) score and radiographic progression. RESULTS: 87 patients were assigned to ADA\/MTX and 85 patients to PBO\/MTX. At baseline, DAS28 was 6.2+\/-0.8 in the ADA\/MTX and 6.3+\/-0.9 in the PBO\/MTX groups. At week 24, treatment with ADA\/MTX compared with PBO\/MTX resulted in a greater reduction in DAS28 (3.0+\/-1.2 vs 3.6+\/-1.4; p=0.009) and other secondary outcomes such as DAS28 remission rate (47.9% vs 29.5%; p=0.021) and HAQ (0.49+\/-0.6 vs 0.72+\/-0.6; p=0.0014). At week 48, the difference in clinical outcomes between groups was not statistically significant (DAS28: 3.2+\/-1.4 vs 3.4+\/-1.6; p=0.41). Radiographic progression at week 48 was significantly greater in patients administered PBO\/MTX (Sharp\/van der Heijde score: ADA\/MTX 2.6 vs PBO\/MTX 6.4; p=0.03, Ratingen score: 1.7 vs 4.2; p=0.01). CONCLUSIONS: A greater reduction in radiographic progression after initial combination therapy with ADA and MTX was seen at week 48, even after discontinuation of ADA treatment at week 24. This sustained effect was not found at the primary endpoint (DAS28 reduction).","address":"","school":"","issn":"1468-2060 (Electronic) ;0003-4967 (Linking)","doi":"10.1136\/annrheumdis-2012-201612","isi":"","pubmed":"","key":"Detert2012","howpublished":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22739990","urllink":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22739990","refid":67932,"weight":67932}
,

{userid:"Sekretariat", "articletype":"article","pages":"","author":"J Detert, H Bastian, J Listing, A Weiss, S Wassenberg, A Liebhaber, K Rockwitz, R Alten, K Kruger, R Rau, C Simon, E Gremmelsbacher, T Braun, B Marsmann, V Hohne-Zimmer, K Egerer, F Buttgereit, G R Burmester","year":"2012","title":"Induction therapy with adalimumab plus methotrexate for 24 weeks followed by methotrexate monotherapy up to week 48 versus methotrexate therapy alone for DMARD-naive patients with early rheumatoid arthritis : HIT HARD, an investigator-initiated study","month":"","journal":"Ann Rheum Dis","publisher":"","volume":"","number":"","note":"Detert, Jacqueline xD;Bastian, Hans xD;Listing, Joachim xD;Weiss, Anja xD;Wassenberg, Siegfried xD;Liebhaber, Anke xD;Rockwitz, Karin xD;Alten, Rieke xD;Kruger, Klaus xD;Rau, Rolf xD;Simon, Christina xD;Gremmelsbacher, Eva xD;Braun, Tanja xD;Marsmann, Bettina xD;Hohne-Zimmer, Vera xD;Egerer, Karl xD;Buttgereit, Frank xD;Burmester, Gerd-R xD;Ann Rheum Dis. 2012 Jul 10.","tags":"2012,Feld E, intern,Website,Feld C, extern","booktitle":"","editor":"","abstract":"OBJECTIVE: To investigate the long-term effects of induction therapy with adalimumab (ADA) plus methotrexate (MTX) in comparison with placebo (PBO) plus MTX in DMARD-naive patients with active early rheumatoid arthritis (RA). METHODS: Patients with active early RA (disease duration of <\/=12 months) were randomly assigned to receive 40 mg ADA subcutaneously every other week (eow) plus MTX 15 mg\/week subcutaneously or PBO plus MTX subcutaneously at 15 mg\/week over 24 weeks. Thereafter, all patients received MTX monotherapy up to week 48. The primary outcome was the Disease Activity Score 28 (DAS28) at week 48. Secondary outcomes included proportions of patients in remission (DAS28<2.6), ACR responses, Health Assessment Questionnaire (HAQ) score and radiographic progression. RESULTS: 87 patients were assigned to ADA\/MTX and 85 patients to PBO\/MTX. At baseline, DAS28 was 6.2+\/-0.8 in the ADA\/MTX and 6.3+\/-0.9 in the PBO\/MTX groups. At week 24, treatment with ADA\/MTX compared with PBO\/MTX resulted in a greater reduction in DAS28 (3.0+\/-1.2 vs 3.6+\/-1.4; p=0.009) and other secondary outcomes such as DAS28 remission rate (47.9% vs 29.5%; p=0.021) and HAQ (0.49+\/-0.6 vs 0.72+\/-0.6; p=0.0014). At week 48, the difference in clinical outcomes between groups was not statistically significant (DAS28: 3.2+\/-1.4 vs 3.4+\/-1.6; p=0.41). Radiographic progression at week 48 was significantly greater in patients administered PBO\/MTX (Sharp\/van der Heijde score: ADA\/MTX 2.6 vs PBO\/MTX 6.4; p=0.03, Ratingen score: 1.7 vs 4.2; p=0.01). CONCLUSIONS: A greater reduction in radiographic progression after initial combination therapy with ADA and MTX was seen at week 48, even after discontinuation of ADA treatment at week 24. This sustained effect was not found at the primary endpoint (DAS28 reduction).","address":"","school":"","issn":"","doi":"10.1136\/annrheumdis-2012-201612","isi":"","pubmed":"","key":"Detert2012","howpublished":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22739990","urllink":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22739990","refid":11633,"weight":11633}
,

{userid:"Sekretariat", "articletype":"article","pages":"","author":"J Detert, H Bastian, J Listing, A Weiss, S Wassenberg, A Liebhaber, K Rockwitz, R Alten, K Kruger, R Rau, C Simon, E Gremmelsbacher, T Braun, B Marsmann, V Hohne-Zimmer, K Egerer, F Buttgereit, G R Burmester","year":"2012","title":"Induction therapy with adalimumab plus methotrexate for 24 weeks followed by methotrexate monotherapy up to week 48 versus methotrexate therapy alone for DMARD-naive patients with early rheumatoid arthritis : HIT HARD, an investigator-initiated study","month":"","journal":"Ann Rheum Dis","publisher":"","volume":"","number":"","note":"Detert, Jacqueline xD;Bastian, Hans xD;Listing, Joachim xD;Weiss, Anja xD;Wassenberg, Siegfried xD;Liebhaber, Anke xD;Rockwitz, Karin xD;Alten, Rieke xD;Kruger, Klaus xD;Rau, Rolf xD;Simon, Christina xD;Gremmelsbacher, Eva xD;Braun, Tanja xD;Marsmann, Bettina xD;Hohne-Zimmer, Vera xD;Egerer, Karl xD;Buttgereit, Frank xD;Burmester, Gerd-R xD;Ann Rheum Dis. 2012 Jul 10.","tags":"2012,Feld E, intern,Website,Feld C, extern","booktitle":"","editor":"","abstract":"OBJECTIVE: To investigate the long-term effects of induction therapy with adalimumab (ADA) plus methotrexate (MTX) in comparison with placebo (PBO) plus MTX in DMARD-naive patients with active early rheumatoid arthritis (RA). METHODS: Patients with active early RA (disease duration of <\/=12 months) were randomly assigned to receive 40 mg ADA subcutaneously every other week (eow) plus MTX 15 mg\/week subcutaneously or PBO plus MTX subcutaneously at 15 mg\/week over 24 weeks. Thereafter, all patients received MTX monotherapy up to week 48. The primary outcome was the Disease Activity Score 28 (DAS28) at week 48. Secondary outcomes included proportions of patients in remission (DAS28<2.6), ACR responses, Health Assessment Questionnaire (HAQ) score and radiographic progression. RESULTS: 87 patients were assigned to ADA\/MTX and 85 patients to PBO\/MTX. At baseline, DAS28 was 6.2+\/-0.8 in the ADA\/MTX and 6.3+\/-0.9 in the PBO\/MTX groups. At week 24, treatment with ADA\/MTX compared with PBO\/MTX resulted in a greater reduction in DAS28 (3.0+\/-1.2 vs 3.6+\/-1.4; p=0.009) and other secondary outcomes such as DAS28 remission rate (47.9% vs 29.5%; p=0.021) and HAQ (0.49+\/-0.6 vs 0.72+\/-0.6; p=0.0014). At week 48, the difference in clinical outcomes between groups was not statistically significant (DAS28: 3.2+\/-1.4 vs 3.4+\/-1.6; p=0.41). Radiographic progression at week 48 was significantly greater in patients administered PBO\/MTX (Sharp\/van der Heijde score: ADA\/MTX 2.6 vs PBO\/MTX 6.4; p=0.03, Ratingen score: 1.7 vs 4.2; p=0.01). CONCLUSIONS: A greater reduction in radiographic progression after initial combination therapy with ADA and MTX was seen at week 48, even after discontinuation of ADA treatment at week 24. This sustained effect was not found at the primary endpoint (DAS28 reduction).","address":"","school":"","issn":"","doi":"10.1136\/annrheumdis-2012-201612","isi":"","pubmed":"","key":"Detert2012","howpublished":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22739990","urllink":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22739990","refid":13411,"weight":13411}
,

{userid:"Sekretariat", "articletype":"article","pages":"","author":"J Detert, H Bastian, J Listing, A Weiss, S Wassenberg, A Liebhaber, K Rockwitz, R Alten, K Kruger, R Rau, C Simon, E Gremmelsbacher, T Braun, B Marsmann, V Hohne-Zimmer, K Egerer, F Buttgereit, G R Burmester","year":"2012","title":"Induction therapy with adalimumab plus methotrexate for 24 weeks followed by methotrexate monotherapy up to week 48 versus methotrexate therapy alone for DMARD-naive patients with early rheumatoid arthritis : HIT HARD, an investigator-initiated study","month":"","journal":"Ann Rheum Dis","publisher":"","volume":"","number":"","note":"Detert, Jacqueline  ;Bastian, Hans  ;Listing, Joachim  ;Weiss, Anja  ;Wassenberg, Siegfried  ;Liebhaber, Anke  ;Rockwitz, Karin  ;Alten, Rieke  ;Kruger, Klaus  ;Rau, Rolf  ;Simon, Christina  ;Gremmelsbacher, Eva  ;Braun, Tanja  ;Marsmann, Bettina  ;Hohne-Zimmer, Vera  ;Egerer, Karl  ;Buttgereit, Frank  ;Burmester, Gerd-R  ;Ann Rheum Dis. 2012 Jul 10.","tags":"2012,Feld E, intern,Website,Feld C, extern","booktitle":"","editor":"","abstract":"OBJECTIVE: To investigate the long-term effects of induction therapy with adalimumab (ADA) plus methotrexate (MTX) in comparison with placebo (PBO) plus MTX in DMARD-naive patients with active early rheumatoid arthritis (RA). METHODS: Patients with active early RA (disease duration of <\/=12 months) were randomly assigned to receive 40 mg ADA subcutaneously every other week (eow) plus MTX 15 mg\/week subcutaneously or PBO plus MTX subcutaneously at 15 mg\/week over 24 weeks. Thereafter, all patients received MTX monotherapy up to week 48. The primary outcome was the Disease Activity Score 28 (DAS28) at week 48. Secondary outcomes included proportions of patients in remission (DAS28<2.6), ACR responses, Health Assessment Questionnaire (HAQ) score and radiographic progression. RESULTS: 87 patients were assigned to ADA\/MTX and 85 patients to PBO\/MTX. At baseline, DAS28 was 6.2+\/-0.8 in the ADA\/MTX and 6.3+\/-0.9 in the PBO\/MTX groups. At week 24, treatment with ADA\/MTX compared with PBO\/MTX resulted in a greater reduction in DAS28 (3.0+\/-1.2 vs 3.6+\/-1.4; p=0.009) and other secondary outcomes such as DAS28 remission rate (47.9% vs 29.5%; p=0.021) and HAQ (0.49+\/-0.6 vs 0.72+\/-0.6; p=0.0014). At week 48, the difference in clinical outcomes between groups was not statistically significant (DAS28: 3.2+\/-1.4 vs 3.4+\/-1.6; p=0.41). Radiographic progression at week 48 was significantly greater in patients administered PBO\/MTX (Sharp\/van der Heijde score: ADA\/MTX 2.6 vs PBO\/MTX 6.4; p=0.03, Ratingen score: 1.7 vs 4.2; p=0.01). CONCLUSIONS: A greater reduction in radiographic progression after initial combination therapy with ADA and MTX was seen at week 48, even after discontinuation of ADA treatment at week 24. This sustained effect was not found at the primary endpoint (DAS28 reduction).","address":"","school":"","issn":"1468-2060 (Electronic)  ;0003-4967 (Linking)","doi":"10.1136\/annrheumdis-2012-201612","isi":"","pubmed":"","key":"Detert2012","howpublished":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22739990","urllink":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22739990","refid":15189,"weight":15189}
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