Clinical efficacy, radiographic and safety findings through 2 years of golimumab treatment in patients with active psoriatic arthritis: Results from a long-term extension of the randomised, placebo-controlled GO-REVEAL study

Annals of the Rheumatic Diseases

Volumn 72, Issue 11, 2013, Pages 1777-1785

  Kavanaugh, Arthur ^a   McInnes, Iain B ^b   Mease, Philip J ^c   Krueger, Gerald G ^d   Gladman, Dafna D ^e   Van Der Heijde, Désirée ^f   Mudivarthy, Surekha ^g   Xu, Weichun ^g   Mack, Michael ^g   Xu, Zhenhua ^g   Beutler, Anna ^g  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF GLASGOW   (United Kingdom)

^c UNIVERSITY OF WASHINGTON   (United States)

^d UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF TORONTO   (Canada)

^f LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^g JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

C REACTIVE PROTEIN; CORTICOSTEROID; GOLIMUMAB; METHOTREXATE; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; ANTIRHEUMATIC AGENT; MONOCLONAL ANTIBODY;

ABSCESS; ACUTE CHOLECYSTITIS; ADULT; AGED; ARTICLE; BASAL CELL CARCINOMA; CELLULITIS; CONTROLLED STUDY; DRUG ACTIVITY; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HISTOPLASMOSIS; HUMAN; INFECTION; INJECTION SITE REACTION; LONG TERM CARE; LUNG SQUAMOUS CELL CARCINOMA; MAJOR CLINICAL STUDY; MALE; MEDICAL SOCIETY; PRIORITY JOURNAL; PROSTATE CANCER; PROTEIN BLOOD LEVEL; PSORIASIS AREA AND SEVERITY INDEX; PSORIATIC ARTHRITIS; RADIODIAGNOSIS; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; RHINOPHARYNGITIS; SEPSIS; SHARP VAN DER HEIJDE SCORE; SIDE EFFECT; THROMBOPHLEBITIS; TUBERCULOSIS; UNITED STATES; UNSPECIFIED SIDE EFFECT; ARTHRITIS, PSORIATIC; DISEASE FREE SURVIVAL; DOUBLE BLIND PROCEDURE; FOOT; HAND JOINT; IMMUNOLOGY; LATENT TUBERCULOSIS; LONGITUDINAL STUDY; MIDDLE AGED; RADIOGRAPHY; TREATMENT OUTCOME;

ADULT; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, PSORIATIC; C-REACTIVE PROTEIN; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; FEMALE; FOOT JOINTS; HAND JOINTS; HUMANS; LATENT TUBERCULOSIS; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 84885181527     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2012-202035     Document Type: Article

References (24)

1. Ash Z, Gaujoux-Viala C, Gossec L, et al. A systematic literature review of drug therapies for the treatment of psoriatic arthritis: current evidence and meta-analysis informing the EULAR recommendations for the management of psoriatic arthritis. Ann Rheum Dis 2012;71:319-26.
2. Shealy D, Cai A, Staquet K, et al. Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor α. mAbs 2010;2:428-39.
3. Kay J, Matteson EL, Dasgupta B, et al. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum 2008;58:964-75.
4. Emery P, Fleischmann RM, Moreland LW, et al. Golimumab, a human anti-tumor necrosis factor α monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthritis Rheum 2009;60:2272-83.
5. Keystone EC, Genovese MC, Klareskog L, et al. Golimumab, a human antibody to tumour necrosis factor α given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis 2009;68:789-96.
6. Keystone E, Genovese MC, Klareskog L, et al. Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: 52-week results of the GO-FORWARD study. Ann Rheum Dis 2010;69:1129-35.
7. Smolen JS, Kay J, Doyle MK, et al. 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.
8. Inman RD, Davis JC Jr, van der Heijde D, et al. Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial. Arthritis Rheum 2008;58: 3402-12.
9. Kavanaugh A, McInnes I, Mease P, et al. Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: twenty-four-week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheum 2009;60:976-86.
10. Erratum in: Arthritis Rheum 2010;62:2555.
11. Kavanaugh A, van der Heijde D, McInnes I, et al. Golimumab, a human TNF-alpha antibody, administered every 4 weeks as a subcutaneous injection in psoriatic arthritis: clinical efficacy, radiographic, and safety findings through 1 year of the randomized, placebo-controlled, GO-REVEAL® study. Arthritis Rheum 2012;64:2504-17.
12. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727-35.
13. Prevoo ML, van 't Hof MA, Kuper HH, et al. 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.
14. Wells G, Becker JC, Teng 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.
15. van der Heijde DM, van Leeuwen MA, van Riel PL, 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.
16. van der Heijde D, Sharp J, Wassenberg S, et al. Psoriatic arthritis imaging: a review of scoring mehods. Ann Rheum Dis 2005;64:ii61-4.
17. Fredriksson T, Pettersson U. Severe psoriasis-oral therapy with a new retinoid. Dermatologica 1978;157:238-44.
18. Fries JF, Spitz P, Kraines RG, et al. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137-45.
19. Fries JF, Spitz PW, Young DY. The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales. J Rheumatol 1982;9: 789-93.
20. Heuft-Dorenbosch L, Spoorenberg A, van Tubergen A, et al. Assessment of enthesitis in ankylosing spondylitis. Ann Rheum Dis 2003;62:127-32.
21. Rich P, Scher RK. Nail Psoriasis Severity Index: a useful tool for evaluation of nail psoriasis. J Am Acad Dermatol 2003;49:206-12.
22. National Cancer Institute. The Surveillance, Epidemiology, and End Results (SEER) Database. 2004. http://seer.cancer.gov/statistics
23. Mease PJ, Ganguly R, Wanke L, et al. How much improvement in functional status is considered important by patients with active psoriatic arthritis: applying the outcome measures in rheumatoid arthritis clinical trials (OMERACT) group guidelines. Abstract presented at EULAR 2004. Ann Rheum Dis 2004;63(Suppl 1):391-2.
24. Leonardi C, Papp K, Strober B, et al. The long-term safety of adalimumab treatment in moderate to severe psoriasis: a comprehensive analysis of all adalimumab exposure in all clinical trials. Am J Clin Dermatol 2011;12:321-37.