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Trial of Tocilizumab in Giant-Cell Arteritis.

Abstract Giant-cell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. The effect of the interleukin-6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in patients with giant-cell arteritis.
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Authors

Mayor MeshTerms
Keywords
Journal Title the new england journal of medicine
Publication Year Start




PMID- 28745999
OWN - NLM
STAT- MEDLINE
DA  - 20170726
DCOM- 20170801
LR  - 20170801
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Linking)
VI  - 377
IP  - 4
DP  - 2017 Jul 27
TI  - Trial of Tocilizumab in Giant-Cell Arteritis.
PG  - 317-328
LID - 10.1056/NEJMoa1613849 [doi]
AB  - BACKGROUND: Giant-cell arteritis commonly relapses when glucocorticoids are
      tapered, and the prolonged use of glucocorticoids is associated with side
      effects. The effect of the interleukin-6 receptor alpha inhibitor tocilizumab on 
      the rates of relapse during glucocorticoid tapering was studied in patients with 
      giant-cell arteritis. METHODS: In this 1-year trial, we randomly assigned 251
      patients, in a 2:1:1:1 ratio, to receive subcutaneous tocilizumab (at a dose of
      162 mg) weekly or every other week, combined with a 26-week prednisone taper, or 
      placebo combined with a prednisone taper over a period of either 26 weeks or 52
      weeks. The primary outcome was the rate of sustained glucocorticoid-free
      remission at week 52 in each tocilizumab group as compared with the rate in the
      placebo group that underwent the 26-week prednisone taper. The key secondary
      outcome was the rate of remission in each tocilizumab group as compared with the 
      placebo group that underwent the 52-week prednisone taper. Dosing of prednisone
      and safety were also assessed. RESULTS: Sustained remission at week 52 occurred
      in 56% of the patients treated with tocilizumab weekly and in 53% of those
      treated with tocilizumab every other week, as compared with 14% of those in the
      placebo group that underwent the 26-week prednisone taper and 18% of those in the
      placebo group that underwent the 52-week prednisone taper (P<0.001 for the
      comparisons of either active treatment with placebo). The cumulative median
      prednisone dose over the 52-week period was 1862 mg in each tocilizumab group, as
      compared with 3296 mg in the placebo group that underwent the 26-week taper
      (P<0.001 for both comparisons) and 3818 mg in the placebo group that underwent
      the 52-week taper (P<0.001 for both comparisons). Serious adverse events occurred
      in 15% of the patients in the group that received tocilizumab weekly, 14% of
      those in the group that received tocilizumab every other week, 22% of those in
      the placebo group that underwent the 26-week taper, and 25% of those in the
      placebo group that underwent the 52-week taper. Anterior ischemic optic
      neuropathy developed in one patient in the group that received tocilizumab every 
      other week. CONCLUSIONS: Tocilizumab, received weekly or every other week,
      combined with a 26-week prednisone taper was superior to either 26-week or
      52-week prednisone tapering plus placebo with regard to sustained
      glucocorticoid-free remission in patients with giant-cell arteritis. Longer
      follow-up is necessary to determine the durability of remission and safety of
      tocilizumab. (Funded by F. Hoffmann-La Roche; ClinicalTrials.gov number,
      NCT01791153 .).
FAU - Stone, John H
AU  - Stone JH
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Tuckwell, Katie
AU  - Tuckwell K
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Dimonaco, Sophie
AU  - Dimonaco S
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Klearman, Micki
AU  - Klearman M
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Aringer, Martin
AU  - Aringer M
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Blockmans, Daniel
AU  - Blockmans D
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Brouwer, Elisabeth
AU  - Brouwer E
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Cid, Maria C
AU  - Cid MC
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Dasgupta, Bhaskar
AU  - Dasgupta B
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Rech, Juergen
AU  - Rech J
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Salvarani, Carlo
AU  - Salvarani C
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Schett, Georg
AU  - Schett G
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Schulze-Koops, Hendrik
AU  - Schulze-Koops H
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Spiera, Robert
AU  - Spiera R
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Unizony, Sebastian H
AU  - Unizony SH
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
FAU - Collinson, Neil
AU  - Collinson N
AD  - From the Massachusetts General Hospital Rheumatology Unit, Harvard Medical
      School, Boston (J.H.S., S.H.U.); Roche Products, Welwyn Garden City (K.T., S.D., 
      N.C.), and Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea
      (B.D.) - both in the United Kingdom; Genentech, South San Francisco, CA (M.K.);
      the Department of Rheumatology, Medicine III, University Medical Center and
      Faculty of Medicine Technische Universitat Dresden, Dresden (M.A.),
      Friedrich-Alexander-University Erlangen-Nurnberg, Department of Internal Medicine
      3-Rheumatology and Immunology (J.R.), and Institute of Clinical Immunology
      (G.S.), Universitatsklinikum Erlangen, Erlangen, and the Division of Rheumatology
      and Clinical Immunology, Department of Medicine IV, University of Munich, Munich 
      (H.S.-K.) - all in Germany; the Department of General Internal Medicine,
      University Hospitals Gasthuisberg, Leuven, Belgium (D.B.); the Department of
      Rheumatology and Clinical Immunology, University of Groningen, University Medical
      Center, Groningen, the Netherlands (E.B.); the Department of Autoimmune Diseases,
      Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques
      August Pi i Sunyer, Barcelona (M.C.C.); the Division of Internal Medicine,
      Azienda Ospedaliera-Istituto di Ricovero e Cura a Carattere Scientifico di Reggio
      Emilia and Universita di Modena e Reggio Emilia, Reggio Emilia, Italy (C.S.); and
      Hospital for Special Surgery, New York (R.S.).
LA  - eng
SI  - ClinicalTrials.gov/NCT01791153
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Glucocorticoids)
RN  - 0 (Receptors, Interleukin-6)
RN  - 0 (interleukin-6 receptor alpha)
RN  - I031V2H011 (tocilizumab)
RN  - VB0R961HZT (Prednisone)
SB  - AIM
SB  - IM
CIN - N Engl J Med. 2017 Jul 27;377(4):385-386. PMID: 28745998
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Giant Cell Arteritis/*drug therapy
MH  - Glucocorticoids/*administration & dosage/adverse effects
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Prednisone/*administration & dosage/adverse effects
MH  - Receptors, Interleukin-6/*antagonists & inhibitors
MH  - Remission Induction
EDAT- 2017/07/27 06:00
MHDA- 2017/08/02 06:00
CRDT- 2017/07/27 06:00
AID - 10.1056/NEJMoa1613849 [doi]
PST - ppublish
SO  - N Engl J Med. 2017 Jul 27;377(4):317-328. doi: 10.1056/NEJMoa1613849.