Placebo-Controlled Trial of Tofacitinib Monotherapy in Rheumatoid Arthritis

In a placebo-controlled trial, monotherapy with tofacitinib, an oral Janus kinase inhibitor, reduced the symptoms and signs of rheumatoid arthritis. Adverse events associated with tofacitinib included infections, decreased neutrophil counts, and elevated LDL cholesterol levels. Rheumatoid arthritis...

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Bibliographic Details
Published inThe New England journal of medicine Vol. 367; no. 6; pp. 495 - 507
Main Authors Fleischmann, Roy, Kremer, Joel, Cush, John, Schulze-Koops, Hendrik, Connell, Carol A, Bradley, John D, Gruben, David, Wallenstein, Gene V, Zwillich, Samuel H, Kanik, Keith S
Format Journal Article
LanguageEnglish
Published Waltham, MA Massachusetts Medical Society 09.08.2012
Subjects
Activities of Daily Living
Adult
Antirheumatic Agents - adverse effects
Antirheumatic Agents - therapeutic use
Arthritis, Rheumatoid - drug therapy
Arthritis, Rheumatoid - immunology
Biological and medical sciences
Cholesterol
Disability Evaluation
Diseases of the osteoarticular system
Double-Blind Method
Drug dosages
Drug therapy
Enzyme inhibitors
Enzyme Inhibitors - adverse effects
Enzyme Inhibitors - therapeutic use
Erythrocyte sedimentation rate
Female
General aspects
Headache
Hepatitis
Humans
Infections
Inflammatory joint diseases
Janus kinase
Janus Kinase 3 - antagonists & inhibitors
Least-Squares Analysis
Leukocyte Count
Male
Medical sciences
Middle Aged
Neutrophils
Patients
Piperidines
Pyrimidines - adverse effects
Pyrimidines - therapeutic use
Pyrroles - adverse effects
Pyrroles - therapeutic use
Respiratory tract diseases
Rheumatic diseases
Rheumatoid arthritis
Severity of Illness Index
Treatment Outcome
Medicine
Immunopathology
Chronic
Rheumatoid arthritis
Diseases of the osteoarticular system
Placebo
Autoimmune disease
Clinical trial
Inflammatory joint disease
Monotherapy
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Abstract In a placebo-controlled trial, monotherapy with tofacitinib, an oral Janus kinase inhibitor, reduced the symptoms and signs of rheumatoid arthritis. Adverse events associated with tofacitinib included infections, decreased neutrophil counts, and elevated LDL cholesterol levels. Rheumatoid arthritis is a chronic autoimmune disease that is characterized by inflammation and destruction of joints. The disease has a major effect on health status and quality of life and imposes a substantial economic burden on patients and society. 1 Tofacitinib (CP-690,550) is a novel oral Janus kinase (JAK) inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for rheumatoid arthritis. Tofacitinib preferentially inhibits signaling through heterodimeric receptors associated with JAK3, JAK1, or both, with functional selectivity over JAK2-paired receptors. 2 Inhibition of JAK1 and JAK3 by tofacitinib blocks signaling for several cytokines (interleukins 2, 4, 7, 9, 15, . . .
AbstractList In a placebo-controlled trial, monotherapy with tofacitinib, an oral Janus kinase inhibitor, reduced the symptoms and signs of rheumatoid arthritis. Adverse events associated with tofacitinib included infections, decreased neutrophil counts, and elevated LDL cholesterol levels. Rheumatoid arthritis is a chronic autoimmune disease that is characterized by inflammation and destruction of joints. The disease has a major effect on health status and quality of life and imposes a substantial economic burden on patients and society. 1 Tofacitinib (CP-690,550) is a novel oral Janus kinase (JAK) inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for rheumatoid arthritis. Tofacitinib preferentially inhibits signaling through heterodimeric receptors associated with JAK3, JAK1, or both, with functional selectivity over JAK2-paired receptors. 2 Inhibition of JAK1 and JAK3 by tofacitinib blocks signaling for several cytokines (interleukins 2, 4, 7, 9, 15, . . .
Tofacitinib (CP-690,550) is a novel oral Janus kinase inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for rheumatoid arthritis. In this phase 3, double-blind, placebo-controlled, parallel-group, 6-month study, 611 patients were randomly assigned, in a 4:4:1:1 ratio, to 5 mg of tofacitinib twice daily, 10 mg of tofacitinib twice daily, placebo for 3 months followed by 5 mg of tofacitinib twice daily, or placebo for 3 months followed by 10 mg of tofacitinib twice daily. The primary end points, assessed at month 3, were the percentage of patients with at least a 20% improvement in the American College of Rheumatology scale (ACR 20), the change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) scores (which range from 0 to 3, with higher scores indicating greater disability), and the percentage of patients with a Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate (DAS28-4[ESR]) of less than 2.6 (with scores ranging from 0 to 9.4 and higher scores indicating more disease activity). At month 3, a higher percentage of patients in the tofacitinib groups than in the placebo groups met the criteria for an ACR 20 response (59.8% in the 5-mg tofacitinib group and 65.7% in the 10-mg tofacitinib group vs. 26.7% in the combined placebo groups, P<0.001 for both comparisons). The reductions from baseline in HAQ-DI scores were greater in the 5-mg and 10-mg tofacitinib groups than in the placebo groups (-0.50 and -0.57 points, respectively, vs. -0.19 points; P<0.001). The percentage of patients with a DAS28-4(ESR) of less than 2.6 was not significantly higher with tofacitinib than with placebo (5.6% and 8.7% in the 5-mg and 10-mg tofacitinib groups, respectively, and 4.4% with placebo; P=0.62 and P=0.10 for the two comparisons). Serious infections developed in six patients who were receiving tofacitinib. Common adverse events were headache and upper respiratory tract infection. Tofacitinib treatment was associated with elevations in low-density lipoprotein cholesterol levels and reductions in neutrophil counts. In patients with active rheumatoid arthritis, tofacitinib monotherapy was associated with reductions in signs and symptoms of rheumatoid arthritis and improvement in physical function. (Funded by Pfizer; ORAL Solo ClinicalTrials.gov number, NCT00814307.).
Tofacitinib (CP-690,550) is a novel oral Janus kinase inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for rheumatoid arthritis.BACKGROUNDTofacitinib (CP-690,550) is a novel oral Janus kinase inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for rheumatoid arthritis.In this phase 3, double-blind, placebo-controlled, parallel-group, 6-month study, 611 patients were randomly assigned, in a 4:4:1:1 ratio, to 5 mg of tofacitinib twice daily, 10 mg of tofacitinib twice daily, placebo for 3 months followed by 5 mg of tofacitinib twice daily, or placebo for 3 months followed by 10 mg of tofacitinib twice daily. The primary end points, assessed at month 3, were the percentage of patients with at least a 20% improvement in the American College of Rheumatology scale (ACR 20), the change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) scores (which range from 0 to 3, with higher scores indicating greater disability), and the percentage of patients with a Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate (DAS28-4[ESR]) of less than 2.6 (with scores ranging from 0 to 9.4 and higher scores indicating more disease activity).METHODSIn this phase 3, double-blind, placebo-controlled, parallel-group, 6-month study, 611 patients were randomly assigned, in a 4:4:1:1 ratio, to 5 mg of tofacitinib twice daily, 10 mg of tofacitinib twice daily, placebo for 3 months followed by 5 mg of tofacitinib twice daily, or placebo for 3 months followed by 10 mg of tofacitinib twice daily. The primary end points, assessed at month 3, were the percentage of patients with at least a 20% improvement in the American College of Rheumatology scale (ACR 20), the change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) scores (which range from 0 to 3, with higher scores indicating greater disability), and the percentage of patients with a Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate (DAS28-4[ESR]) of less than 2.6 (with scores ranging from 0 to 9.4 and higher scores indicating more disease activity).At month 3, a higher percentage of patients in the tofacitinib groups than in the placebo groups met the criteria for an ACR 20 response (59.8% in the 5-mg tofacitinib group and 65.7% in the 10-mg tofacitinib group vs. 26.7% in the combined placebo groups, P<0.001 for both comparisons). The reductions from baseline in HAQ-DI scores were greater in the 5-mg and 10-mg tofacitinib groups than in the placebo groups (-0.50 and -0.57 points, respectively, vs. -0.19 points; P<0.001). The percentage of patients with a DAS28-4(ESR) of less than 2.6 was not significantly higher with tofacitinib than with placebo (5.6% and 8.7% in the 5-mg and 10-mg tofacitinib groups, respectively, and 4.4% with placebo; P=0.62 and P=0.10 for the two comparisons). Serious infections developed in six patients who were receiving tofacitinib. Common adverse events were headache and upper respiratory tract infection. Tofacitinib treatment was associated with elevations in low-density lipoprotein cholesterol levels and reductions in neutrophil counts.RESULTSAt month 3, a higher percentage of patients in the tofacitinib groups than in the placebo groups met the criteria for an ACR 20 response (59.8% in the 5-mg tofacitinib group and 65.7% in the 10-mg tofacitinib group vs. 26.7% in the combined placebo groups, P<0.001 for both comparisons). The reductions from baseline in HAQ-DI scores were greater in the 5-mg and 10-mg tofacitinib groups than in the placebo groups (-0.50 and -0.57 points, respectively, vs. -0.19 points; P<0.001). The percentage of patients with a DAS28-4(ESR) of less than 2.6 was not significantly higher with tofacitinib than with placebo (5.6% and 8.7% in the 5-mg and 10-mg tofacitinib groups, respectively, and 4.4% with placebo; P=0.62 and P=0.10 for the two comparisons). Serious infections developed in six patients who were receiving tofacitinib. Common adverse events were headache and upper respiratory tract infection. Tofacitinib treatment was associated with elevations in low-density lipoprotein cholesterol levels and reductions in neutrophil counts.In patients with active rheumatoid arthritis, tofacitinib monotherapy was associated with reductions in signs and symptoms of rheumatoid arthritis and improvement in physical function. (Funded by Pfizer; ORAL Solo ClinicalTrials.gov number, NCT00814307.).CONCLUSIONSIn patients with active rheumatoid arthritis, tofacitinib monotherapy was associated with reductions in signs and symptoms of rheumatoid arthritis and improvement in physical function. (Funded by Pfizer; ORAL Solo ClinicalTrials.gov number, NCT00814307.).
BackgroundTofacitinib (CP-690,550) is a novel oral Janus kinase inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for rheumatoid arthritis.MethodsIn this phase 3, double-blind, placebo-controlled, parallel-group, 6-month study, 611 patients were randomly assigned, in a 4:4:1:1 ratio, to 5 mg of tofacitinib twice daily, 10 mg of tofacitinib twice daily, placebo for 3 months followed by 5 mg of tofacitinib twice daily, or placebo for 3 months followed by 10 mg of tofacitinib twice daily. The primary end points, assessed at month 3, were the percentage of patients with at least a 20% improvement in the American College of Rheumatology scale (ACR 20), the change from baseline in Health Assessment Questionnaire–Disability Index (HAQ-DI) scores (which range from 0 to 3, with higher scores indicating greater disability), and the percentage of patients with a Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate (DAS28-4[ESR]) of less than 2.6 (with scores ranging from 0 to 9.4 and higher scores indicating more disease activity).ResultsAt month 3, a higher percentage of patients in the tofacitinib groups than in the placebo groups met the criteria for an ACR 20 response (59.8% in the 5-mg tofacitinib group and 65.7% in the 10-mg tofacitinib group vs. 26.7% in the combined placebo groups, P<0.001 for both comparisons). The reductions from baseline in HAQ-DI scores were greater in the 5-mg and 10-mg tofacitinib groups than in the placebo groups (−0.50 and −0.57 points, respectively, vs. −0.19 points; P<0.001). The percentage of patients with a DAS28-4(ESR) of less than 2.6 was not significantly higher with tofacitinib than with placebo (5.6% and 8.7% in the 5-mg and 10-mg tofacitinib groups, respectively, and 4.4% with placebo; P=0.62 and P=0.10 for the two comparisons). Serious infections developed in six patients who were receiving tofacitinib. Common adverse events were headache and upper respiratory tract infection. Tofacitinib treatment was associated with elevations in low-density lipoprotein cholesterol levels and reductions in neutrophil counts.ConclusionsIn patients with active rheumatoid arthritis, tofacitinib monotherapy was associated with reductions in signs and symptoms of rheumatoid arthritis and improvement in physical function. (Funded by Pfizer; ORAL Solo ClinicalTrials.gov number, NCT00814307.)
Author Gruben, David
Zwillich, Samuel H
Kremer, Joel
Connell, Carol A
Wallenstein, Gene V
Schulze-Koops, Hendrik
Bradley, John D
Cush, John
Fleischmann, Roy
Kanik, Keith S
Author_xml – sequence: 1
  givenname: Roy
  surname: Fleischmann
  fullname: Fleischmann, Roy
  organization: From the Metroplex Clinical Research Center (R.F.) and Baylor Research Institute (J.C.) — both in Dallas; the Center for Rheumatology, Albany Medical College, Albany, NY (J.K.); the Division of Rheumatology, Medizinische Klinik und Poliklinik IV, University of Munich, Munich, Germany (H.S.-K.); and Pfizer, Groton, CT (C.A.C., J.D.B., D.G., G.V.W., S.H.Z., K.S.K.)
– sequence: 2
  givenname: Joel
  surname: Kremer
  fullname: Kremer, Joel
  organization: From the Metroplex Clinical Research Center (R.F.) and Baylor Research Institute (J.C.) — both in Dallas; the Center for Rheumatology, Albany Medical College, Albany, NY (J.K.); the Division of Rheumatology, Medizinische Klinik und Poliklinik IV, University of Munich, Munich, Germany (H.S.-K.); and Pfizer, Groton, CT (C.A.C., J.D.B., D.G., G.V.W., S.H.Z., K.S.K.)
– sequence: 3
  givenname: John
  surname: Cush
  fullname: Cush, John
  organization: From the Metroplex Clinical Research Center (R.F.) and Baylor Research Institute (J.C.) — both in Dallas; the Center for Rheumatology, Albany Medical College, Albany, NY (J.K.); the Division of Rheumatology, Medizinische Klinik und Poliklinik IV, University of Munich, Munich, Germany (H.S.-K.); and Pfizer, Groton, CT (C.A.C., J.D.B., D.G., G.V.W., S.H.Z., K.S.K.)
– sequence: 4
  givenname: Hendrik
  surname: Schulze-Koops
  fullname: Schulze-Koops, Hendrik
  organization: From the Metroplex Clinical Research Center (R.F.) and Baylor Research Institute (J.C.) — both in Dallas; the Center for Rheumatology, Albany Medical College, Albany, NY (J.K.); the Division of Rheumatology, Medizinische Klinik und Poliklinik IV, University of Munich, Munich, Germany (H.S.-K.); and Pfizer, Groton, CT (C.A.C., J.D.B., D.G., G.V.W., S.H.Z., K.S.K.)
– sequence: 5
  givenname: Carol A
  surname: Connell
  fullname: Connell, Carol A
  organization: From the Metroplex Clinical Research Center (R.F.) and Baylor Research Institute (J.C.) — both in Dallas; the Center for Rheumatology, Albany Medical College, Albany, NY (J.K.); the Division of Rheumatology, Medizinische Klinik und Poliklinik IV, University of Munich, Munich, Germany (H.S.-K.); and Pfizer, Groton, CT (C.A.C., J.D.B., D.G., G.V.W., S.H.Z., K.S.K.)
– sequence: 6
  givenname: John D
  surname: Bradley
  fullname: Bradley, John D
  organization: From the Metroplex Clinical Research Center (R.F.) and Baylor Research Institute (J.C.) — both in Dallas; the Center for Rheumatology, Albany Medical College, Albany, NY (J.K.); the Division of Rheumatology, Medizinische Klinik und Poliklinik IV, University of Munich, Munich, Germany (H.S.-K.); and Pfizer, Groton, CT (C.A.C., J.D.B., D.G., G.V.W., S.H.Z., K.S.K.)
– sequence: 7
  givenname: David
  surname: Gruben
  fullname: Gruben, David
  organization: From the Metroplex Clinical Research Center (R.F.) and Baylor Research Institute (J.C.) — both in Dallas; the Center for Rheumatology, Albany Medical College, Albany, NY (J.K.); the Division of Rheumatology, Medizinische Klinik und Poliklinik IV, University of Munich, Munich, Germany (H.S.-K.); and Pfizer, Groton, CT (C.A.C., J.D.B., D.G., G.V.W., S.H.Z., K.S.K.)
– sequence: 8
  givenname: Gene V
  surname: Wallenstein
  fullname: Wallenstein, Gene V
  organization: From the Metroplex Clinical Research Center (R.F.) and Baylor Research Institute (J.C.) — both in Dallas; the Center for Rheumatology, Albany Medical College, Albany, NY (J.K.); the Division of Rheumatology, Medizinische Klinik und Poliklinik IV, University of Munich, Munich, Germany (H.S.-K.); and Pfizer, Groton, CT (C.A.C., J.D.B., D.G., G.V.W., S.H.Z., K.S.K.)
– sequence: 9
  givenname: Samuel H
  surname: Zwillich
  fullname: Zwillich, Samuel H
  organization: From the Metroplex Clinical Research Center (R.F.) and Baylor Research Institute (J.C.) — both in Dallas; the Center for Rheumatology, Albany Medical College, Albany, NY (J.K.); the Division of Rheumatology, Medizinische Klinik und Poliklinik IV, University of Munich, Munich, Germany (H.S.-K.); and Pfizer, Groton, CT (C.A.C., J.D.B., D.G., G.V.W., S.H.Z., K.S.K.)
– sequence: 10
  givenname: Keith S
  surname: Kanik
  fullname: Kanik, Keith S
  organization: From the Metroplex Clinical Research Center (R.F.) and Baylor Research Institute (J.C.) — both in Dallas; the Center for Rheumatology, Albany Medical College, Albany, NY (J.K.); the Division of Rheumatology, Medizinische Klinik und Poliklinik IV, University of Munich, Munich, Germany (H.S.-K.); and Pfizer, Groton, CT (C.A.C., J.D.B., D.G., G.V.W., S.H.Z., K.S.K.)
BackLink http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26196689$$DView record in Pascal Francis
https://www.ncbi.nlm.nih.gov/pubmed/22873530$$D View this record in MEDLINE/PubMed
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2015 INIST-CNRS
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Keywords Medicine
Immunopathology
Chronic
Rheumatoid arthritis
Diseases of the osteoarticular system
Placebo
Autoimmune disease
Clinical trial
Inflammatory joint disease
Monotherapy
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Snippet In a placebo-controlled trial, monotherapy with tofacitinib, an oral Janus kinase inhibitor, reduced the symptoms and signs of rheumatoid arthritis. Adverse...
Tofacitinib (CP-690,550) is a novel oral Janus kinase inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for...
BackgroundTofacitinib (CP-690,550) is a novel oral Janus kinase inhibitor that is being investigated as a targeted immunomodulator and disease-modifying...
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SubjectTerms Activities of Daily Living
Adult
Antirheumatic Agents - adverse effects
Antirheumatic Agents - therapeutic use
Arthritis, Rheumatoid - drug therapy
Arthritis, Rheumatoid - immunology
Biological and medical sciences
Cholesterol
Disability Evaluation
Diseases of the osteoarticular system
Double-Blind Method
Drug dosages
Drug therapy
Enzyme inhibitors
Enzyme Inhibitors - adverse effects
Enzyme Inhibitors - therapeutic use
Erythrocyte sedimentation rate
Female
General aspects
Headache
Hepatitis
Humans
Infections
Inflammatory joint diseases
Janus kinase
Janus Kinase 3 - antagonists & inhibitors
Least-Squares Analysis
Leukocyte Count
Male
Medical sciences
Middle Aged
Neutrophils
Patients
Piperidines
Pyrimidines - adverse effects
Pyrimidines - therapeutic use
Pyrroles - adverse effects
Pyrroles - therapeutic use
Respiratory tract diseases
Rheumatic diseases
Rheumatoid arthritis
Severity of Illness Index
Treatment Outcome
Title Placebo-Controlled Trial of Tofacitinib Monotherapy in Rheumatoid Arthritis
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https://www.ncbi.nlm.nih.gov/pubmed/22873530
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