Maintenance of Clinical and Radiographic Benefit with Intravenous Golimumab Therapy in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy: Week-112 Efficacy and Safety Results of the Open-Label Long-Term Extension of a Phase III, Double-Blind, Randomized, Placebo-Controlled Trial

Arthritis Care and Research

Volumn 67, Issue 12, 2015, Pages 1627-1636

  Bingham, Clifton O ^a,f   Mendelsohn, Alan M ^b   Kim, Lilianne ^b   Xu, Zhenhua ^b   Leu, Jocelyn ^b   Han, Chenglong ^c   Lo, Kim Hung ^b   Westhovens, Rene ^d   Weinblatt, Michael E ^e  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^c JOHNSON AND JOHNSON   (United States)

^d UNIVERSITY OF LEUVEN   (Belgium)

^e BRIGHAM AND WOMEN S HOSPITAL   (United States)

^f Mason Lord Center Tower   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; C REACTIVE PROTEIN; GOLIMUMAB; METHOTREXATE; NEUTRALIZING ANTIBODY; PLACEBO; ANTIRHEUMATIC AGENT; AUTACOID; BIOLOGICAL MARKER; MONOCLONAL ANTIBODY;

ADULT; AGED; AMERICAN COLLEGE OF RHEUMATOLOGY RESPONSE CRITERION 20; AMERICAN COLLEGE OF RHEUMATOLOGY RESPONSE CRITERION 50; AMERICAN COLLEGE OF RHEUMATOLOGY RESPONSE CRITERION 70; ARTICLE; BASAL CELL CARCINOMA; BOWEN DISEASE; BREAST CANCER; BRONCHITIS; CANDIDIASIS; CAUSE OF DEATH; CHRONIC LYMPHATIC LEUKEMIA; CONTROLLED STUDY; CROSSOVER PROCEDURE; DAS28; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; ERYSIPELAS; FEMALE; FOLLOW UP; HUMAN; HYPERTENSION; IMMUNOGENICITY; INFUSION RELATED REACTION; LUNG ADENOCARCINOMA; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE ASSESSMENT; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; PNEUMONIA; PULMONARY CRYPTOCOCCOSIS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; TUBERCULOSIS; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; UTERINE CERVIX CARCINOMA; ARTHRITIS, RHEUMATOID; BLOOD; CLINICAL TRIAL; COMBINATION DRUG THERAPY; CONVALESCENCE; DISABILITY; DRUG ADMINISTRATION; ERYTHROCYTE SEDIMENTATION RATE; INTRAVENOUS DRUG ADMINISTRATION; METABOLISM; PATHOPHYSIOLOGY; QUESTIONNAIRE; RADIOGRAPHY; TIME FACTOR; TREATMENT OUTCOME;

ADMINISTRATION, INTRAVENOUS; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOMARKERS; BLOOD SEDIMENTATION; C-REACTIVE PROTEIN; CROSS-OVER STUDIES; DISABILITY EVALUATION; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; HUMANS; INFLAMMATION MEDIATORS; METHOTREXATE; QUALITY OF LIFE; RECOVERY OF FUNCTION; SURVEYS AND QUESTIONNAIRES; TIME FACTORS; TREATMENT OUTCOME;

EID: 84956658918     PISSN: 2151464X     EISSN: 21514658     Source Type: Journal    
DOI: 10.1002/acr.22556     Document Type: Article

References (27)

1. Weinblatt ME, Bingham CO III, Mendelsohn AM, Kim L, Mack M, Lu J, et al., Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: Results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial. Ann Rheum Dis 2013; 72: 381-9.
2. 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.
3. Weinblatt ME, Westhovens R, Mendelsohn AM, Kim L, Lo KH, Sheng S, et al., Radiographic benefit and maintenance of clinical benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: Results up to 1 year of the phase 3, randomised, multicentre, double blind, placebo controlled GO-FURTHER trial. Ann Rheum Dis 2014; 73: 2152-9.
4. 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.
5. Van Riel PL, van Gestel AM, Scott DL., EULAR handbook of clinical assessments in rheumatoid arthritis. Alphen Aan Den Rijn (Netherlands): Van Zuiden Communications, BV; 2000.
6. 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 (Oxford) 2003; 42: 244-57.
7. Aletaha D, Nell VP, Stamm T, Uffmann M, Pflugbeil S, Machold K, et al., Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: Validation of a clinical activity score. Arthritis Res Ther 2005; 7: R796-806.
8. Fries JF, Spitz P, Kraines RG, Holman HR., Measurement of patient outcome in arthritis. Arthritis Rheum 1980; 23: 137-45.
9. Lubeck DP., Patient-reported outcomes and their role in the assessment of rheumatoid arthritis. Pharmacoeconomics 2004; 22: 27-38.
10. Van der Heijde DM, van Leeuwen MA, van Riel PL, Koster AM, van 't Hof MA, van Rijswijk MH, et al., Biannual radiographic assessments of hands and feet in a three-year prospective followup of patients with early rheumatoid arthritis. Arthritis Rheum 1992; 35: 26-34.
11. EuroQol Group. EuroQol: A new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199-208.
12. Gusi N, Olivares PR, Rajendram R., The EQ-5D health-related quality of life questionnaire. In:, Preedy V, Watson R, editors. Handbook of disease burdens and quality of life measures. New York: Springer; 2010. pp. 87-99.
13. Cella D, Yount S, Sorensen M, Chartash E, Sengupta N, Grober J., Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis. J Rheumatol 2005; 32: 811-9.
14. Zhou H, Jang H, Fleischmann RM, Bouman-Thio E, Xu Z, Marini JC, et al., Pharmacokinetics and safety of golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with rheumatoid arthritis. J Clin Pharmacol 2007; 47: 383-96.
15. Bruynesteyn K, Boers M, Kostense P, van der Linden S, van der Heijde D., Deciding on progression of joint damage in paired films of individual patients: Smallest detectable difference or change. Ann Rheum Dis 2005; 64: 179-82.
16. Bingham CO, Weinblatt M, Han C, Gathany TA, Kim L, Lo KH, et al., The effect of intravenous golimumab on health-related quality of life in rheumatoid arthritis: 24-week results of the phase 3 GO-FURTHER trial. J Rheumatol 2014; 41: 1067-76.
17. Landewe R, Strand V, van der Heijde D., From inhibition of radiographic progression to maintaining structural integrity: A methodological framework for radiographic progression in rheumatoid arthritis and psoriatic arthritis clinical trials. Ann Rheum Dis 2013; 72: 1113-7.
18. Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, et al., 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken) 2012; 64: 625-39.
19. Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, 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.
20. Baumgartner SW, Fleischmann RM, Moreland LW, Schiff MH, Markenson J, Whitmore JB., Etanercept (Enbrel) in patients with rheumatoid arthritis with recent onset versus established disease: Improvement in disability. J Rheumatol 2004; 31: 1532-7.
21. Lillegraven S, van der Heijde D, Uhlig T, Kvien TK, Haavardsholm EA., What is the clinical relevance of erosions and joint space narrowing in RA? Nat Rev Rheumatol 2012; 8: 117-20.
22. Quinn MA, Emery P., Window of opportunity in early rheumatoid arthritis: Possibility of altering the disease process with early intervention. Clin Exp Rheumatol 2003; 21: S154-7.
23. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al., The PREMIER study: A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum 2006; 54: 26-37.
24. Combe B, Codreanu C, Fiocco U, Gaubitz M, Geusens PP, Kvien TK, et al., Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: A double-blind randomised 2-year study. Ann Rheum Dis 2009; 68: 1146-52.
25. Emery P, Fleischmann RM, Doyle MK, Strusberg I, Durez P, Nash P, et al., Golimumab, a human anti-tumor necrosis factor monoclonal antibody, injected subcutaneously every 4 weeks in patients with active rheumatoid arthritis who had never taken methotrexate: 1-year and 2-year clinical, radiologic, and physical function findings of a phase III, multicenter, randomized, double-blind, placebo-controlled study. Arthritis Care Res (Hoboken) 2013; 65: 1732-42.
26. Keystone EC, Genovese MC, Hall S, Miranda PC, Bae SC, Palmer W, et al., Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: Results through 2 years of the GO-FORWARD study extension. J Rheumatol 2013; 40: 1097-103.
27. Maini RN, Breedveld FC, Kalden JR, Smolen JS, Furst D, Weisman MH, et al., Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate. Arthritis Rheum 2004; 50: 1051-65.