Effectiveness and safety of golimumab in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis under real-life clinical conditions: non-interventional GO-NICE study in Germany

Klaus Krüger, Gerd R Burmester, Siegfried Wassenberg, Martin Bohl-Bühler, Matthias H Thomas, Klaus Krüger, Gerd R Burmester, Siegfried Wassenberg, Martin Bohl-Bühler, Matthias H Thomas

Abstract

Objective: The Non Interventional Evaluation with Golumimab (GO-NICE) study aimed to document patient and treatment characteristics as well as clinical effectiveness and safety in adult patients newly treated with the tumour necrosis factor inhibitor golimumab (GLM).

Design: Prospective non-interventional study with 24-month observation per patient.

Setting: 158 office-based and clinical-based physicians in Germany.

Intervention: GLM administered in the 50 mg dose subcutaneously in monthly intervals under real-life conditions.

Results: Of the 1613 included patients, 1458 patients were eligible for final analysis: 474 patients with rheumatoid arthritis (RA, 54.9±13.4 years, 72.8% women, 64.7% biologic-naïve), 501 with psoriatic arthritis (PsA, 50.5±12.1 years, 54.1% women, 56.5% biologic-naïve) and 483 with ankylosing spondylitis (AS, 43.6±12.3 years, 66.5% men, 61.0% biologic-naïve). 664 patients completed follow-up (2-year retention rate 45.5%). Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28-ESR) decreased from 5.0 to 2.9 after 24 months (p<0.0001) in patients with RA, and Bath Ankylosing Spondylitis Disease Index score decreased from 5.1 to 2.4 (p<0.0001) in patients with AS. Response rate calculated in patients with PsA by modified Psoriatic Arthritis Response Criteria was 67.9% after 24 months. Most adverse events were of mild or moderate nature, and no new safety signals were detected. According to the physicians' clinical assessments, treatment with GLM was successful (no adverse drug reaction and a clear or moderate therapeutic effect in an individual patient) in 55.0%-56.6% of patients with RA, PsA and AS, respectively, at month 3, increasing from 74.5% to 76.1% at month 24.

Conclusions: GLM subcutaneously once monthly led to substantial improvements in clinical effectiveness in patients with various inflammatory rheumatic diseases who could be followed up in a real-life setting in Germany. The treatment was well tolerated, and the safety profile of GLM was consistent with that observed in the previous randomised controlled trials.

Trial registration number: NCT01313858.

Keywords: ankylosing spondylitis; biologics; golimumab; non-interventional; psoriatic arthritis; real-life setting; rheumatoid arthritis.

Conflict of interest statement

Competing interests: KK has received funds for consultancy or research from: AbbVie, BMS, Celgene, Janssen Biologics, MSD, Pfizer, Roche and Sanofi-Aventis. GRB has received funds for consultancy or research from AbbVie, Bristol-Myers Squibb, MSD, Pfizer, Roche and UCB. SW has received funds for consultancy or research from AbbVie, Chugai, Janssen Biologics, MSD, Novartis, Pfizer and Roche. MB-B has received funds for consultancy or research from: AbbVie, Hexal, MSD, Roche and UCB. MHT is full-time employee of MSD Sharp & Dohme GmbH.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Disposition of patients. A retention rate of 45.5% over 24 months was observed. AS, ankylosing spondylitis; BL, baseline; PsA, psoriatic arthritis; RA, rheumatoid arthritis.
Figure 2
Figure 2
Disease activity (DAS28) over time in patients with RA. BL, baseline; DAS28, Disease Activity Score, 28 joints; RA, rheumatoid arthritis.
Figure 3
Figure 3
Percentages of patients with RA with high, moderate, low disease activity, or remission over time. HDA: DAS28>5.1, MDA: 3.2

Figure 4

Proportion of patients PsA with…

Figure 4

Proportion of patients PsA with a positive response (PsARC). PsA, psoriatic arthritis; PsARC,…

Figure 4
Proportion of patients PsA with a positive response (PsARC). PsA, psoriatic arthritis; PsARC, Psoriatic Arthritis Response Criteria.

Figure 5

BASDAI over time in patients…

Figure 5

BASDAI over time in patients with AS. AS, ankylosing spondylitis; BASDAI, Bath Ankylosing…

Figure 5
BASDAI over time in patients with AS. AS, ankylosing spondylitis; BASDAI, Bath Ankylosing Spondylitis Disease Index; BL, baseline.
Figure 4
Figure 4
Proportion of patients PsA with a positive response (PsARC). PsA, psoriatic arthritis; PsARC, Psoriatic Arthritis Response Criteria.
Figure 5
Figure 5
BASDAI over time in patients with AS. AS, ankylosing spondylitis; BASDAI, Bath Ankylosing Spondylitis Disease Index; BL, baseline.

References

    1. Thompson C, Davies R, Choy E. Anti cytokine therapy in chronic inflammatory arthritis. Cytokine 2016;86:92–9. 10.1016/j.cyto.2016.07.015
    1. Boyce EG, Halilovic J, Stan-Ugbene O. Golimumab: Review of the efficacy and tolerability of a recently approved tumor necrosis factor-α inhibitor. Clin Ther 2010;32:1681–703. 10.1016/j.clinthera.2010.09.003
    1. European Agency for the Evaluation of Medicinal Products (EMA). Simponi (Golimumab) Summary of Product Characteristics (SmPC). Latest renewal of authorisation. (accessed on 28 Feb 2018).
    1. Keystone EC, Genovese MC, Klareskog L, et al. . Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis 2009;68:789–96. 10.1136/ard.2008.099010
    1. Kavanaugh A, McInnes I, Mease P, et al. . Golimumab, a new human tumor necrosis factor alpha 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. 10.1002/art.24403
    1. Inman RD, Davis JC, 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. 10.1002/art.23969
    1. Kay J, Fleischmann R, Keystone E, et al. . Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis. J Rheumatol 2016;43:2120–30. 10.3899/jrheum.160420
    1. Keystone EC, Genovese MC, Hall S, et al. . Safety and Efficacy of Subcutaneous Golimumab in Patients with Active Rheumatoid Arthritis despite Methotrexate Therapy: Final 5-year Results of the GO-FORWARD Trial. J Rheumatol 2016;43:298–306. 10.3899/jrheum.150712
    1. Emery P, Fleischmann RM, Strusberg I, et al. . Efficacy and Safety of Subcutaneous Golimumab in Methotrexate-Naive Patients With Rheumatoid Arthritis: Five-Year Results of a Randomized Clinical Trial. Arthritis Care Res 2016;68:744–52. 10.1002/acr.22759
    1. Deodhar A, Braun J, Inman RD, et al. . Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 5-year results of the GO-RAISE study. Ann Rheum Dis 2015;74:757–61. 10.1136/annrheumdis-2014-205862
    1. 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. 10.1002/art.1780380107
    1. 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. 10.1136/ard.2007.084459
    1. Mease PJ. Measures of psoriatic arthritis: Tender and Swollen Joint Assessment, Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), Modified Nail Psoriasis Severity Index (mNAPSI), Mander/Newcastle Enthesitis Index (MEI), Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC), Maastricht Ankylosing Spondylitis Enthesis Score (MASES), Leeds Dactylitis Index (LDI), Patient Global for Psoriatic Arthritis, Dermatology Life Quality Index (DLQI), Psoriatic Arthritis Quality of Life (PsAQOL), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Joint Activity Index (PsAJAI), Disease Activity in Psoriatic Arthritis (DAPSA), and Composite Psoriatic Disease Activity Index (CPDAI). Arthritis Care Res 2011;63(Suppl 11):S64–85. 10.1002/acr.20577
    1. Clegg DO, Reda DJ, Mejias E, et al. . Comparison of sulfasalazine and placebo in the treatment of psoriatic arthritis. A Department of Veterans Affairs Cooperative Study. Arthritis Rheum 1996;39:2013–20. 10.1002/art.1780391210
    1. Calin A, Garrett S, Whitelock H, et al. . A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol 1994;21:2281–5.
    1. Iannone F, Santo L, Anelli MG, et al. . Golimumab in real-life settings: 2 Years drug survival and predictors of clinical outcomes in rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis. Semin Arthritis Rheum 2017;47:108–14. 10.1016/j.semarthrit.2017.01.008
    1. Manara M, Caporali R, Favalli EG, et al. . Two-year retention rate of golimumab in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: data from the LORHEN registry. Clin Exp Rheumatol 2017;35:804–9.
    1. Dalén J, Svedbom A, Black CM, et al. . Treatment persistence among patients with immune-mediated rheumatic disease newly treated with subcutaneous TNF-alpha inhibitors and costs associated with non-persistence. Rheumatol Int 2016;36:987–95. 10.1007/s00296-016-3423-5
    1. Pattloch D, Richter A, Manger B, et al. . [The first biologic for rheumatoid arthritis: factors influencing the therapeutic decision]. Z Rheumatol 2017;76:210–8. 10.1007/s00393-016-0174-3
    1. Keystone EC, Genovese MC, Hall S, 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. 10.3899/jrheum.120584
    1. Kavanaugh A, McInnes IB, Mease PJ, et al. . 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. Ann Rheum Dis 2013;72:1777–85. 10.1136/annrheumdis-2012-202035
    1. Braun J, Deodhar A, Inman RD, et al. . Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 104-week results of the GO-RAISE study. Ann Rheum Dis 2012;71:661–7. 10.1136/ard.2011.154799
    1. Kay J, Fleischmann R, Keystone E, et al. . Golimumab 3-year safety update: an analysis of pooled data from the long-term extensions of randomised, double-blind, placebo-controlled trials conducted in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis. Ann Rheum Dis 2015;74:538–46. 10.1136/annrheumdis-2013-204195
    1. Delgado-Rodríguez M, Llorca J. Bias. J Epidemiol Community Health 2004;58:635–41. 10.1136/jech.2003.008466

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