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  string(746) "Background; Biologics are efficacious in treating immune disorders. However, a proportion of patients have eventual loss of response due to immunogenicity against the biologic, which can be prevented by combination therapy with immunomodulators (IM). The optimal dose of IM when used in combination with biologics remains unknown.
Objective; To determine the optimal dose of IM when used in combination with biologics.
Study Design; Patient level data of clinical trials with infliximab (IFX) and golimumab (GO) will be analyzed. Patients will be categorized into those who received therapy as monotherapy or in combination with an IM (azathioprine (AZA)/methotrexate (MTX)). Those taking IM will be divided into high vs low AZA (? or" ["project_brief_bg"]=> string(2763) "Biologic agents such as infliximab (IFX) have been shown to be highly efficacious in treating immune disorders such as inflammatory bowel disease and rheumatoid arthritis. A significant proportion of patients, however, have no initial response (primary non-response) or eventual loss of response (secondary loss of response) to therapy. It is thought that a majority of the cases of secondary loss of response are due to the formation of antibodies against the therapeutic agent, termed immunogenicity. One method to prevent immunogenicity is the concomitant treatment with an immunosuppressive drug such as azathioprine or methotrexate, referred to as combination therapy. Azathioprine or methotrexate are also used as the sole therapy to maintain remission in these diseases, and their dose is optimized based on the weight of the patient. The optimal dose of azathioprine or methotrexate when used in combination with a biologic therapy remains unknown. It is common for clinicians to administer relatively low doses of IMs in combination with biologic therapies in order to minimize side effects while decreasing the rate of immunogenicity, however no evidence exists to support this practice in inflammatory bowel disease. In a recently published retrospective study we showed that a higher dose of azathioprine was superior to a low dose in preventing immunogenicity against IFX in patients with ulcerative colitis. Patients receiving greater than 2.0 mg/kg of azathioprine had greater IFX levels than those receiving less than 2.0 mg/kg and those receiving IFX alone. Antibodies directed against IFX (ATI) were less common in patients receiving higher doses of IFX further supporting the hypothesis that higher levels of IFX were a result of decreased immunogenicity. The clinical outcome was superior in patients receiving high dose azathioprine while those taking low dose AZA had indistinguishable outcomes from those receiving IFX monotherapy.
It has been shown that combination therapy is superior to monotherapy with biologic agents in inflammatory bowel disease, but the optimal dose of IM in combination therapy has yet to be examined in a prospective study. We propose that this can be shown by looking at the data of previously published clinical trials with IFX and goliumumab. The proposed study will use individual patient level data from the clinical studies. Efficacy of interventions (monotherapy vs high or low AZA or MTX, respectively) will be assessed by network meta-analysis. The results of our study would have substantial impact as it will provide new insights for optimization of combination therapy that will allow patients to stay in durable long-term remission with biologics through effective prevention of immunogenicity." ["project_specific_aims"]=> string(515) "Specific hypothesis:
We hypothesize that concomitant use of ?high dose? immunomodulators (IM) with biologic therapy will be correlated with greater blood levels of the biologic than concomitant ?low-dose? IM, or biologic monotherapy.
Primary aim:
AIM 1: To compare14-week biologic trough levels between patients receiving biologic therapy in one of five groups: monotherapy, with ?low dose? azathioprine (< 2.0 mg/kg), or with ?high dose? azathioprine (?2.0 mg/kg), with ?low dose? methotrexate (" ["project_study_design"]=> string(0) "" ["project_study_design_exp"]=> string(0) "" ["project_purposes"]=> array(3) { [0]=> array(2) { ["value"]=> string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations" ["label"]=> string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations" } [1]=> array(2) { ["value"]=> string(36) "Participant-level data meta-analysis" ["label"]=> string(36) "Participant-level data meta-analysis" } [2]=> array(2) { ["value"]=> string(66) "Summary-level data meta-analysis using only data from YODA Project" ["label"]=> string(66) "Summary-level data meta-analysis using only data from YODA Project" } } ["project_purposes_exp"]=> string(0) "" ["project_software_used"]=> array(2) { ["value"]=> string(1) "R" ["label"]=> string(1) "R" } ["project_software_used_exp"]=> string(0) "" ["project_research_methods"]=> string(362) "Data Source: Patient level data from the clinical trials of infliximab and golimumab.
Inclusion Criteria: All patients who participated in the clinical trials of infliximab and golimumab.
Exclusion Criteria: Patients who did not complete the study or with insufficient data. Patients who changed the doses of immunomodulators during the study period." ["project_main_outcome_measure"]=> string(262) "The main outcome is to compare week 14 biologic trough levels between patients receiving biologic therapy in one of five groups: monotherapy, with ?low dose? azathioprine (< 2.0 mg/kg) or with ?high dose? azathioprine (?2.0 mg/kg), with ?low dose? methotrexate (" ["project_main_predictor_indep"]=> string(248) "The main independent variable is the level of concomitant immunosuppressant medication and will be divided into one of five groups: monotherapy, ?low dose? azathioprine (< 2.0 mg/kg), ?high dose? azathioprine (?2.0 mg/kg), ?low dose? methotrexate (" ["project_other_variables_interest"]=> string(752) "Secondary variables include the trough level of biologic therapy at 52 weeks, and will be collected as described above in the main outcome at the 52 week time point. Antibodies against infliximab or golimumab will be characterized as a binary variable of present or absent as demonstrated by specific laboratory evaluations for each of the five groups as described above. The clinical outcomes will be characterized as the number of patients in clinical remission at 14 and 52 weeks in each of the five study groups. Clinical remission is defined in rheumatoid arthritis as a sustained improvement of 50% from baseline using the American college of rheumatology (20) criteria. Remission in Crohn?s disease is defined as a crohn?s disease activity index" ["project_stat_analysis_plan"]=> string(517) "Analysis will be done separately for each disease and biologic. For example, Crohn's disease treated with infliximab, ulcerative colitis treated with golimumab, and so on. Patient level data of primary and secondary aims will be summarized for each treatment arm (monotherapy, high or low AZA or MTX), and will then be compared by network meta-analysis. This method will allow analyzing, simultaneously, three or more different interventions in one meta-analysis and to confirm the rank of superiority of treatment." ["project_timeline"]=> string(242) "Estimated start date April 1, 2015 with analysis completion by October 1, 2015. Manuscript draft and submission by December 1, 2015. Results will be reported back to Yoda following manuscript revisions and acceptance, estimated April 1, 2016." ["project_dissemination_plan"]=> string(201) "We expect the data analysis to result in preparation of a manuscript for publication in professional journals. Suitable journals include Gastroenterology, JAMA, or American journal of gastroenterology." ["project_bibliography"]=> string(266) "

1. Hayes, M. J., Stein, A. C. and Sakuraba, A. (2014), Comparison of efficacy, pharmacokinetics, and immunogenicity between infliximab mono- versus combination therapy in ulcerative colitis. Journal of Gastroenterology and Hepatology: 2014 Jun;29(6):1177-85.

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array(1) { [0]=> string(15) "johnson-johnson" }

pi country
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pi affil
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products
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num of trials
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res
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2015-0339

General Information

How did you learn about the YODA Project?: Scientific Publication

Conflict of Interest

Request Clinical Trials

Associated Trial(s):
  1. NCT00036374 - A Randomized, Double-Blind Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate for the Treatment of Patients With Polyarticular Juvenile Rheumatoid Arthritis
  2. NCT00036439 - A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis
  3. NCT00096655 - A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis
  4. NCT00207675 - A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF a Chimeric Monoclonal Antibody (Infliximab, REMICADE) in Pediatric Subjects With Moderate to Severe CROHN'S Disease
  5. NCT00336492 - A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis
  6. NCT00264550 - A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy
  7. NCT00265083 - A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis
  8. NCT00299546 - A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti TNFa Agent(s)
  9. NCT00361335 - A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy
  10. NCT00487539 - A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis
  11. NCT01248780 - A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy
  12. NCT01248793 - A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects with Ankylosing Spondylitis
  13. NCT00207662 - ACCENT I - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn's Disease
  14. NCT00207766 - ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease
  15. NCT00269867 - A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment
  16. NCT00236028 - A Randomized, Double-blind, Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared With Methotrexate Alone for the Treatment of Patients With Early Rheumatoid Arthritis
  17. NCT00265096 - A Multicenter, Randomized, Double-blind, Placebo controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Psoriatic Arthritis
  18. NCT01009086 - A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis
  19. NCT01077362 - A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents
  20. NCT01551290 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Infliximab in Chinese Subjects With Active Ulcerative Colitis
  21. NCT01190839 - Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence
  22. NCT00269854 - A Placebo-Controlled, Dose-Ranging Study Followed by a Placebo-Controlled, Repeated-Dose Extension of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Active Crohn's Disease
  23. Efficacy and safety of retreatment with anti-tumor necrosis factor antibody (infliximab) to maintain remission in Crohn's disease.
  24. NCT00973479 - A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFalpha Monoclonal Antibody, Administered Intravenously, in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
  25. NCT00207701 - A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therapy
  26. NCT00771667 - A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy
  27. NCT01369329 - A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)
  28. NCT01369342 - A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2)
  29. NCT00488631 - A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
  30. NCT01369355 - A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease
  31. NCT00267969 - A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial Evaluating the Efficacy and Safety of Ustekinumab (CNTO 1275) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
  32. NCT00307437 - A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
  33. NCT00267956 - A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of CNTO 1275, a Fully Human Anti-IL-12 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis
  34. NCT01483599 - A Phase 2 Multicenter, Randomized, Placebo- and Active-Comparator-Controlled, Dose-Ranging Trial to Evaluate CNTO 1959 for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis (X-PLORE)
  35. NCT00207714 - A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate
  36. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis
  37. NCT00488774 - A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis
  38. NCT01550744 - A Phase 3b, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis
  39. NCT02203032 - A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
  40. NCT00723528 - A Placebo-Controlled Double-Blind Comparative Study of CNTO1275 in Patients With Plaque Type Psoriasis
  41. NCT00265122 - A Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects With Moderately to Severely Active Crohn's Disease
  42. NCT00320216 - A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Study of Single and Multiple Dose Regimens With Subcutaneous CNTO 1275 (Human Monoclonal Antibody to IL-12) in Subjects With Moderate to Severe Psoriasis
  43. NCT00454584 - A Phase 3, Multicenter, Randomized Study Comparing CNTO 1275 and Etanercept for the Treatment of Moderate to Severe Plaque Psoriasis
  44. NCT00747344 - A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Korean and Taiwanese Subjects With Moderate to Severe Plaque-type Psoriasis
  45. NCT01008995 - A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Chinese Subjects With Moderate to Severe Plaque-type Psoriasis
  46. NCT01059773 - An Exploratory Trial to Assess Naturalistic Safety and Efficacy Outcomes in Patients With Moderate to Severe Plaque Psoriasis Transitiioned to Ustekinumab From Previous Methotrexate Therapy (TRANSIT)
  47. NCT01090427 - A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)
  48. NCT01230827 - A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
  49. NCT02186873 - A Study of Golimumab in Participants With Active Ankylosing Spondylitis
  50. NCT02181673 - A Study of Golimumab in Participants With Active Psoriatic Arthritis
  51. NCT01004432 - Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)
  52. NCT01863771 - A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis
  53. NCT01988961 - A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
  54. NCT01962974 - A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)
  55. NCT00207740 - A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 148 Administered Subcutaneously in Symptomatic Subjects With Severe Persistent Asthma
  56. NCT00036387 - A Randomized, Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-Rheumatic Drug
  57. NCT02438787 - A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Subjects With Active Radiographic Axial Spondyloarthritis
  58. NCT02437162 - A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF Alpha Naive Subjects With Active Radiographic Axial Spondyloarthritis
  59. NCT02407223 - A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis
  60. NCT00060502 - A Phase II, Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Anti-TNF a Monoclonal Antibody (Infliximab) to Treat Cancer-Related Cachexia in Subjects With Pancreatic Cancer
  61. NCT00073437 - A Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Efficacy of Infliximab (Remicade) in Subjects With Chronic Sarcoidosis With Pulmonary Involvement
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Data Request Status

Status: Published

Research Proposal

Project Title: Impact of the dose of immunomodulators on pharmacokinetics of biologics: Patient level meta-analysis of randomized controlled trials

Scientific Abstract: Background; Biologics are efficacious in treating immune disorders. However, a proportion of patients have eventual loss of response due to immunogenicity against the biologic, which can be prevented by combination therapy with immunomodulators (IM). The optimal dose of IM when used in combination with biologics remains unknown.
Objective; To determine the optimal dose of IM when used in combination with biologics.
Study Design; Patient level data of clinical trials with infliximab (IFX) and golimumab (GO) will be analyzed. Patients will be categorized into those who received therapy as monotherapy or in combination with an IM (azathioprine (AZA)/methotrexate (MTX)). Those taking IM will be divided into high vs low AZA (? or

Brief Project Background and Statement of Project Significance: Biologic agents such as infliximab (IFX) have been shown to be highly efficacious in treating immune disorders such as inflammatory bowel disease and rheumatoid arthritis. A significant proportion of patients, however, have no initial response (primary non-response) or eventual loss of response (secondary loss of response) to therapy. It is thought that a majority of the cases of secondary loss of response are due to the formation of antibodies against the therapeutic agent, termed immunogenicity. One method to prevent immunogenicity is the concomitant treatment with an immunosuppressive drug such as azathioprine or methotrexate, referred to as combination therapy. Azathioprine or methotrexate are also used as the sole therapy to maintain remission in these diseases, and their dose is optimized based on the weight of the patient. The optimal dose of azathioprine or methotrexate when used in combination with a biologic therapy remains unknown. It is common for clinicians to administer relatively low doses of IMs in combination with biologic therapies in order to minimize side effects while decreasing the rate of immunogenicity, however no evidence exists to support this practice in inflammatory bowel disease. In a recently published retrospective study we showed that a higher dose of azathioprine was superior to a low dose in preventing immunogenicity against IFX in patients with ulcerative colitis. Patients receiving greater than 2.0 mg/kg of azathioprine had greater IFX levels than those receiving less than 2.0 mg/kg and those receiving IFX alone. Antibodies directed against IFX (ATI) were less common in patients receiving higher doses of IFX further supporting the hypothesis that higher levels of IFX were a result of decreased immunogenicity. The clinical outcome was superior in patients receiving high dose azathioprine while those taking low dose AZA had indistinguishable outcomes from those receiving IFX monotherapy.
It has been shown that combination therapy is superior to monotherapy with biologic agents in inflammatory bowel disease, but the optimal dose of IM in combination therapy has yet to be examined in a prospective study. We propose that this can be shown by looking at the data of previously published clinical trials with IFX and goliumumab. The proposed study will use individual patient level data from the clinical studies. Efficacy of interventions (monotherapy vs high or low AZA or MTX, respectively) will be assessed by network meta-analysis. The results of our study would have substantial impact as it will provide new insights for optimization of combination therapy that will allow patients to stay in durable long-term remission with biologics through effective prevention of immunogenicity.

Specific Aims of the Project: Specific hypothesis:
We hypothesize that concomitant use of ?high dose? immunomodulators (IM) with biologic therapy will be correlated with greater blood levels of the biologic than concomitant ?low-dose? IM, or biologic monotherapy.
Primary aim:
AIM 1: To compare14-week biologic trough levels between patients receiving biologic therapy in one of five groups: monotherapy, with ?low dose? azathioprine (< 2.0 mg/kg), or with ?high dose? azathioprine (?2.0 mg/kg), with ?low dose? methotrexate (

Study Design:

What is the purpose of the analysis being proposed? Please select all that apply.: New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations Participant-level data meta-analysis Summary-level data meta-analysis using only data from YODA Project

Software Used: R

Data Source and Inclusion/Exclusion Criteria to be used to define the patient sample for your study: Data Source: Patient level data from the clinical trials of infliximab and golimumab.
Inclusion Criteria: All patients who participated in the clinical trials of infliximab and golimumab.
Exclusion Criteria: Patients who did not complete the study or with insufficient data. Patients who changed the doses of immunomodulators during the study period.

Primary and Secondary Outcome Measure(s) and how they will be categorized/defined for your study: The main outcome is to compare week 14 biologic trough levels between patients receiving biologic therapy in one of five groups: monotherapy, with ?low dose? azathioprine (< 2.0 mg/kg) or with ?high dose? azathioprine (?2.0 mg/kg), with ?low dose? methotrexate (

Main Predictor/Independent Variable and how it will be categorized/defined for your study: The main independent variable is the level of concomitant immunosuppressant medication and will be divided into one of five groups: monotherapy, ?low dose? azathioprine (< 2.0 mg/kg), ?high dose? azathioprine (?2.0 mg/kg), ?low dose? methotrexate (

Other Variables of Interest that will be used in your analysis and how they will be categorized/defined for your study: Secondary variables include the trough level of biologic therapy at 52 weeks, and will be collected as described above in the main outcome at the 52 week time point. Antibodies against infliximab or golimumab will be characterized as a binary variable of present or absent as demonstrated by specific laboratory evaluations for each of the five groups as described above. The clinical outcomes will be characterized as the number of patients in clinical remission at 14 and 52 weeks in each of the five study groups. Clinical remission is defined in rheumatoid arthritis as a sustained improvement of 50% from baseline using the American college of rheumatology (20) criteria. Remission in Crohn?s disease is defined as a crohn?s disease activity index

Statistical Analysis Plan: Analysis will be done separately for each disease and biologic. For example, Crohn's disease treated with infliximab, ulcerative colitis treated with golimumab, and so on. Patient level data of primary and secondary aims will be summarized for each treatment arm (monotherapy, high or low AZA or MTX), and will then be compared by network meta-analysis. This method will allow analyzing, simultaneously, three or more different interventions in one meta-analysis and to confirm the rank of superiority of treatment.

Narrative Summary: Antibody-based therapies, termed biologics, are highly effective in treating immune disorders. Many patients, however, lose response to treatment due to the development of their own antibodies against the therapy. One method to prevent this problem is the co-administration of a second therapy to depress the immune system, an immunomodulator (IM). The optimal dose of IMs when used with biologics remains unknown. The proposed study will look at the dose of IM and its impact on antibody formation against the biologic as well as the resultant efficacy of that therapy. The results of our study will allow us to better utilize biologic therapy to keep patients in durable, long-term remission.

Project Timeline: Estimated start date April 1, 2015 with analysis completion by October 1, 2015. Manuscript draft and submission by December 1, 2015. Results will be reported back to Yoda following manuscript revisions and acceptance, estimated April 1, 2016.

Dissemination Plan: We expect the data analysis to result in preparation of a manuscript for publication in professional journals. Suitable journals include Gastroenterology, JAMA, or American journal of gastroenterology.

Bibliography:

1. Hayes, M. J., Stein, A. C. and Sakuraba, A. (2014), Comparison of efficacy, pharmacokinetics, and immunogenicity between infliximab mono- versus combination therapy in ulcerative colitis. Journal of Gastroenterology and Hepatology: 2014 Jun;29(6):1177-85.