Golimumab in patients with active rheumatoid arthritis after treatment with tumor necrosis factor α inhibitors: Findings with up to five years of treatment in the multicenter, randomized, double-blind, placebo-controlled, phase 3 GO-AFTER study

Arthritis Research and Therapy

Volumn 17, Issue 1, 2015, Pages

  Smolen, Josef S ^a   Kay, Jonathan ^b   Doyle, Mittie ^c   Landewé, Robert ^d   Matteson, Eric L ^e   Gaylis, Norman ^f   Wollenhaupt, Jürgen ^g   Murphy, Frederick T ^h,i   Xu, Stephen ^j   Zhou, Yiying ^j   Hsia, Elizabeth C ^i,j  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

^c ALEXION PHARMACEUTICALS   (United States)

^d UNIVERSITY OF AMSTERDAM   (Netherlands)

^e Mayo Clinic College of Medicine   (United States)

^f Arthritis/Rheumatic Dis Specialties   (United States)

^g Hamburg Center for Pediatric and Adolescent Rheumatology   (Germany)

^h Altoona Center of Clinical Research   (United States)

ⁱ HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^j JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

more..

Author keywords

[No Author keywords available]

Indexed keywords

GOLIMUMAB; METHOTREXATE; PLACEBO; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; IMMUNOLOGIC FACTOR; MONOCLONAL ANTIBODY; TUMOR NECROSIS FACTOR;

ARTHRALGIA; ARTICLE; BACKACHE; BRONCHITIS; CELLULITIS; CONTROLLED STUDY; COUGHING; DIARRHEA; DIVERTICULITIS; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; HEADACHE; HUMAN; IMMUNOGENICITY; INJECTION SITE INFECTION; INTENTION TO TREAT ANALYSIS; LONG TERM CARE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NAUSEA; OSTEOARTHRITIS; PHASE 3 CLINICAL TRIAL; PNEUMONIA; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SEPSIS; SINUSITIS; TREATMENT RESPONSE; ULCERATIVE COLITIS; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VOMITING; ANTAGONISTS AND INHIBITORS; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; TREATMENT OUTCOME;

ANTIBODIES, MONOCLONAL; ARTHRITIS, RHEUMATOID; DOUBLE-BLIND METHOD; HUMANS; IMMUNOLOGIC FACTORS; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84925957520     PISSN: 14786354     EISSN: 14786362     Source Type: Journal    
DOI: 10.1186/s13075-015-0516-6     Document Type: Article

References (19)

1. Smolen JS, Kay J, Doyle MK, Landewé R, Matteson EL, Wollenhaupt J, et al. GO-AFTER study investigators: golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor α inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009;374:210-21.
2. Smolen JS, Kay J, Landewé RB, Matteson EL, Gaylis N, Wollenhaupt J, et al. Golimumab in patients with active rheumatoid arthritis who have previous experience with tumour necrosis factor inhibitors: results of a long-term extension of the randomised, double-blind, placebo-controlled GO-AFTER study through week 160. Ann Rheum Dis. 2012;71:1671-9.
3. Buch MH, Aletaha D, Emery P, Smolen JS. Reporting of long-term extension studies: lack of consistency calls for consensus. Ann Rheum Dis. 2011;70:886-90.
4. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988;31:315-24.
5. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology: preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727-35.
6. Prevoo ML, van't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint-counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995;38:44-8.
7. Aletaha D, Landewe R, Karonitsch T, Bathon J, Boers M, Bombardier C, et al. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Arthritis Rheum. 2008;59:1371-7.
8. van Riel PL, van Gestel AM, Scott DL. EULAR handbook of clinical assessments in rheumatoid arthritis. Alphen Aan Den Rijn, the Netherlands: Van Zuiden Communications B.V; 2000. p. 1-55.
9. Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, et al. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009;68:954-60.
10. Smolen JS, Breedveld FC, Schiff MH, Kalden JR, Emery P, Eberl G, et al. A simplified disease activity index for rheumatoid arthritis for use in clinical practice. Rheumatology. 2003;42:244-57.
11. Felson DT, Smolen JS, Wells G, Zhang B, van Tuyl LH, Funovits J, et al. American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Arthritis Rheum. 2011;63:573-86.
12. Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980;23:137-45.
13. Wells GA, Tugwell P, Kraag GR, Baker PR, Groh J, Redelmeier DA. Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. J Rheumatol. 1993;20:557-60.
14. National Cancer Institute. The Surveillance, Epidemiology, and End Results (SEER). http://seer.cancer.gov (2004).
15. Smolen JS, Landewé R, Breedveld FC, Dougados M, Emery P, Gaujoux-Viala C, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73:492-509.
16. Ni Mhuircheartaigh OM, Matteson EL, Green AB, Crowson CS. Trends in serious infections in rheumatoid arthritis. J Rheumatol. 2013;40:611-6.
17. Baecklund E, Iliadou A, Askling J, Ekbom A, Backlin C, Granath F, et al. Association of chronic inflammation, not its treatment, with increased lymphoma risk in rheumatoid arthritis. Arthritis Rheum. 2006;54:692-701.
18. Askling J, van Vollenhoven RF, Granath F, Raaschou P, Fored CM, Baecklund E, et al. Cancer risk in patients with rheumatoid arthritis treated with anti-tumor necrosis factor α therapies: does the risk change with the time since start of treatment? Arthritis Rheum. 2009;60:3180-9.
19. Wolfe F, Michaud K. The effect of methotrexate and anti-tumor necrosis factor therapy on the risk of lymphoma in rheumatoid arthritis in 19,562 patients during 89,710 person-years of observation. Arthritis Rheum. 2007;56:1433-9.