@article{KleinertTonyKrauseetal.2012,
  author    = {Kleinert, Stefan and Tony, Hans-Peter and Krause, Andreas and Feuchtenberger, Martin and Wassenberg, Siegfried and Richter, Constanze and R{\"o}ther, Ekkehard and Spieler, Wolfgang and Gnann, Holger and Wittig, Bianca M.},
  title     = {Impact of patient and disease characteristics on therapeutic success during adalimumab treatment of patients with rheumatoid arthritis: data from a German},
  series = {Rheumatology International},
  volume    = {32},
  journal   = {Rheumatology International},
  number    = {9},
  doi       = {10.1007/s00296-011-2033-5},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-126220},
  pages     = {2759-2767},
  year      = {2012},
  abstract  = {The objective of this study was to use data from a noninterventional study to evaluate the effectiveness of adalimumab in rheumatoid arthritis (RA) patients during routine clinical practice and to explore the potential impact of patient and disease characteristics in response to adalimumab therapy. A total of 2,625 RA patients with specified data at baseline (prior to initiating adalimumab treatment) and 12 months entered this study between April 2003 and March 2009. We evaluated response to adalimumab therapy and conducted stepwise regression and subgroup analyses of factors influencing therapeutic response. During the 1-year adalimumab treatment period, disease activity decreased from a baseline mean disease activity score-28 joints (DAS28) of 5.9-3.9, while functional capacity improved from 59.0 to 68.4 Funktionsfragebogen Hannover (FFbH) percentage points. In multivariate regression models, high baseline DAS28 was the strongest positive predictor for decrease in disease activity, and high baseline functional capacity was associated with reduced gains in functional capacity. Male gender was a positive predictor of therapeutic response for both disease activity and functional capacity, while older age and multiple previous biologics were associated with a reduced therapeutic response. Subset analyses provided further support for the impact of baseline DAS28, FFbH, and prior biologic therapy on therapeutic response during treatment. We conclude that treatment with adalimumab leads to decreased disease activity and improved function during routine clinical practice. Patients with high disease activity and low functional capacity are particularly benefitted by adalimumab therapy.},
  language  = {en}
}
@article{KleinertTonyKrauseetal.2012,
  author    = {Kleinert, Stefan and Tony, Hans-Peter and Krause, Andreas and Feuchtenberger, Martin and Wassenberg, Siegfried and Richter, Constanze and R{\"a}ther, Ekkehard and Spieler, Wolfgang and Gnann, Holger and Wittig, Bianca M.},
  title     = {Impact of patient and disease characteristics on therapeutic success during adalimumab treatment of patients with rheumatoid arthritis: data from a German noninterventional observational study},
  series = {Rheumatology International},
  volume    = {32},
  journal   = {Rheumatology International},
  number    = {9},
  doi       = {10.1007/s00296-011-2033-5},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-125118},
  pages     = {2759-2767},
  year      = {2012},
  abstract  = {The objective of this study was to use data from a noninterventional study to evaluate the effectiveness of adalimumab in rheumatoid arthritis (RA) patients during routine clinical practice and to explore the potential impact of patient and disease characteristics in response to adalimumab therapy. A total of 2,625 RA patients with specified data at baseline (prior to initiating adalimumab treatment) and 12 months entered this study between April 2003 and March 2009. We evaluated response to adalimumab therapy and conducted stepwise regression and subgroup analyses of factors influencing therapeutic response. During the 1-year adalimumab treatment period, disease activity decreased from a baseline mean disease activity score-28 joints (DAS28) of 5.9-3.9, while functional capacity improved from 59.0 to 68.4 Funktionsfragebogen Hannover (FFbH) percentage points. In multivariate regression models, high baseline DAS28 was the strongest positive predictor for decrease in disease activity, and high baseline functional capacity was associated with reduced gains in functional capacity. Male gender was a positive predictor of therapeutic response for both disease activity and functional capacity, while older age and multiple previous biologics were associated with a reduced therapeutic response. Subset analyses provided further support for the impact of baseline DAS28, FFbH, and prior biologic therapy on therapeutic response during treatment. We conclude that treatment with adalimumab leads to decreased disease activity and improved function during routine clinical practice. Patients with high disease activity and low functional capacity are particularly benefitted by adalimumab therapy.},
  language  = {en}
}
@article{ScharbatkeBehrensSchmalzingetal.2016,
  author    = {Scharbatke, Eva C. and Behrens, Frank and Schmalzing, Marc and Koehm, Michaela and Greger, Gerd and Gnann, Holger and Burkhardt, Harald and Tony, Hans-Peter},
  title     = {Association of improvement in pain with therapeutic response as determined by individual improvement criteria in patients with rheumatoid arthritis},
  series = {Arthritis Care \& Research},
  volume    = {68},
  journal   = {Arthritis Care \& Research},
  number    = {11},
  doi       = {10.1002/acr.22884},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-186817},
  pages     = {1607-1615},
  year      = {2016},
  abstract  = {Objective To use statistical methods to establish a threshold for individual response in patient-reported outcomes (PROs) in patients with rheumatoid arthritis. Methods We used an analysis of variance model in patients on stable therapy (discovery cohort) to establish critical differences (d(crit)) for the minimum change associated with a significant individual patient response (beyond normal variation) in the PRO measures of pain (0-10), fatigue (0-10), and function (Funktionsfragebogen Hannover questionnaire; 0-100). We then evaluated PRO responses in patients initiating adalimumab in a noninterventional study (treatment cohort). Results In the discovery cohort (n=700), PROs showed excellent long-term retest reliability. The minimum change that exceeded random fluctuation was conservatively determined to be 3 points for pain, 4 points for fatigue, and 16 points for function. In the treatment cohort (n=2,788), 1,483 patients (53.2\%) achieved a significant individual therapeutic response as assessed by Disease Activity Score in 28 joints (DAS28)-d(crit) (1.8 points) after 12 months of adalimumab treatment; 68.5\% of patients with a DAS28-d(crit) response achieved a significant improvement in pain, whereas approximately 40\% achieved significant improvements in fatigue or function. Significant improvements in all 3 PROs occurred in 22.7\% of patients; 22.8\% did not have any significant PRO responses. In contrast, significant improvements in all 3 PROs occurred in only 4.4\% of 1,305 patients who did not achieve a DAS28-d(crit) response at month 12, and 59.1\% did not achieve any significant PRO responses. Conclusion The establishment of critical differences in PROs distinguishes true responses from random variation and provides insights into appropriate patient management.},
  language  = {en}
}