Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Mar 27;7(1):5.
doi: 10.1186/s41927-023-00329-8.

Effectiveness and safety of intravenous golimumab with and without concomitant methotrexate in patients with rheumatoid arthritis in the prospective, noninterventional AWARE study

Aaron Broadwell  1 , Joy Schechtman  2 , Douglas Conaway  3 , Alan Kivitz  4 , Natalie J Shiff  5   6 , Shawn Black  7 , Stephen Xu  7 , Wayne Langholff  7 , Sergio Schwartzman  8 , Jeffrey R Curtis  9
Affiliations

Effectiveness and safety of intravenous golimumab with and without concomitant methotrexate in patients with rheumatoid arthritis in the prospective, noninterventional AWARE study

Aaron Broadwell et al. BMC Rheumatol. .

Abstract

Background: Biologic therapies are often prescribed for patients with rheumatoid arthritis (RA) who have inadequate responses to or are intolerant of methotrexate (MTX) and patients with poor prognostic indicators. This post hoc analysis evaluated effectiveness and safety of intravenous golimumab + MTX vs golimumab without MTX in RA patients.

Methods: AWARE, a real-world, prospective and pragmatic, Phase 4 study, compared effectiveness and safety of golimumab and infliximab in biologic-naïve and biologic-experienced patients. All treatment decisions were at the discretion of the treating rheumatologist. Effectiveness was evaluated by mean change in CDAI scores at Months 6 and 12. Safety was monitored through approximately 1 year.

Results: Among 685 golimumab-treated patients, 420 (61%) received concomitant MTX during the study and 265 (39%) did not receive MTX after enrollment; 63% and 72%, respectively, discontinued the study. Relative to golimumab without MTX, golimumab + MTX patients had shorter mean disease duration (8.7 vs 10.0 years) and a lower proportion received prior biologics (60% vs 72%); mean ± standard deviation (SD) baseline CDAI scores were similar (30.8 ± 15.1 and 32.6 ± 15.4). Mean ± SD changes from baseline in CDAI scores at Months 6 and 12, respectively, were similar with golimumab + MTX (- 10.2 ± 14.2 and - 10.8 ± 13.8) and golimumab without MTX (- 9.6 ± 12.9 and - 9.9 ± 13.1). The incidence of adverse events/100 patient-years (PY) (95% confidence interval [CI]) was 155.6 (145.6, 166.1) for golimumab + MTX and 191.2 (176.2, 207.1) for golimumab without MTX; infections were the most common type. The incidence of infusion reactions/100PY (95% CI) was 2.1 (1.1, 3.6) for golimumab + MTX versus 5.1 (2.9, 8.3) for golimumab without MTX; none were considered serious. For golimumab + MTX versus golimumab without MTX, rates/100PY (95% CI) of serious infections, opportunistic infections, and malignancies were 2.6 (1.5, 4.3) versus 7.0 (4.4, 10.6), 0.9 (0.3, 2.0) versus 2.6 (1.1, 5.0), and 3.0 (1.7, 4.7) versus 1.0 (0.2, 2.8), respectively.

Conclusions: Mean change in CDAI score in the golimumab without MTX group was generally similar to that of the golimumab + MTX group through 1 year, regardless of prior biologic therapy. Adverse events were consistent with the known IV golimumab safety profile. These results provide real world evidential data that may assist healthcare providers and patients with RA in making informed treatment decisions.

Trial registration: clinicaltrials.gov NCT02728934 05/04/2016.

Keywords: Clinical disease activity index; Infusion reactions; Intravenous golimumab; Methotrexate; Rheumatoid arthritis; Safety.

PubMed Disclaimer

Conflict of interest statement

AB received consulting fees from Abbvie, Amgen, Aurinia, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer, and Sandoz and speaker fees from Amgen, Abbvie, Eli Lilly and Company, Horizon, Janssen, Mallinckrodt, Novartis, Pfizer, Radius, Sanofi/Regeneron, and UCB. JS received speaker fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, ChemoCentryx, Eli Lilly and Company, Novartis, Mallinckrodt, Pfizer, Radius, Scipher, and UCB; and is on the scientific advisory board of Janssen. DC received consulting fees from Janssen and speaking fees from Janssen and Amgen. AK received stock options or bond holdings in a for-profit corporation or self-directed pension plan from Amgen, Gilead Sciences, Novartis, Pfizer, and Sanofi; received research grants from Janssen Research and Development; is an owner or partner for Amgen, Gilead Sciences, Inc, Novartis, Pfizer, and Sanofi; received consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Flexion, Genzyme, Gilead Sciences, Janssen, Pfizer, Sanofi, SUN Pharma Advanced Research, and UCB; and speaker fees from AbbVie, Celgene, Eli Lilly and Company, Flexion, Genzyme, Horizon, Merck, Novartis, Pfizer, and Sanofi. SS received speaker fees from AbbVie, Eli Lilly and Company, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB and consultant fees from AbbVie, Eli Lilly and Company, Gilead, Janssen, Myriad, Novartis, Regeneron, Samsung, Sanofi, and UCB; owns stock in Amgen, Boston Scientific, Gilead, Medtronic, and Pfizer; and is a board member of National Psoriasis Foundation, and on the scientific advisory boards of Jubilant, Myriad, and Stelexis. JRC received grant/research support from AbbVie, Amgen, Bristol-Myers Squibb, CorEvitas, Eli Lilly and Company, Janssen, Myriad, Novartis, Pfizer, Sanofi, and UCB and consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, CorEvitas, Eli Lilly and Company, Janssen, Myriad, Novartis, Pfizer, Sanofi, and UCB. NJS is an employee of Janssen Scientific Affairs, LLC, a wholly owned subsidiary of Johnson and Johnson, and owns stock in AbbVie, Gilead, Iovance, Jazz Pharmaceuticals, Johnson and Johnson, Novavax, and Viatris. SB, SX, and WL are employees of Janssen Research and Development, LLC, a wholly owned subsidiary of Johnson and Johnson, and own stock in Johnson and Johnson.

Figures

Fig. 1
Fig. 1
Mean change from baseline at Month 6 (a) and Month 12 (b) in CDAI score for IV golimumab with and without methotrexate (last observation carried forward for missing data) in biologic-naïve and biologic-experienced patients. CDAI Clinical Disease Activity Index, IV intravenous, SD standard deviation
Fig. 2
Fig. 2
Proportion of all patients in remission (CDAI ≤ 2.8) and with low disease activity (CDAI > 2.8 to ≤ 10), moderate disease activity (CDAI > 10 to ≤ 22), and high disease activity (CDAI > 22) at baseline (a) and Months 3 (b), 6 (c), and 12 (d) for IV golimumab with and without methotrexate. CDAI Clinical Disease Activity Index, IV intravenous
See this image and copyright information in PMC

References

    1. Sparks JA. Rheumatoid arthritis. Ann Intern Med. 2019;170:ITC1–ITC16. doi: 10.7326/AITC201901010. - DOI - PubMed
    1. Weinblatt ME. Methotrexate in rheumatoid arthritis: a quarter century of development. Trans Am Clin Climatol Assoc. 2013;124:16–25. - PMC - PubMed
    1. Smolen JS, Landewé RBM, Bijlsma JWJ, Burmester GR, Dougados M, Kerschbaumer A, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79:685–699. doi: 10.1136/annrheumdis-2019-216655. - DOI - PubMed
    1. Fraenkel L, Bathon JM, England BR, St Clair EW, Arayssi T, Carandang K, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken) 2021;73:924–939. doi: 10.1002/acr.24596. - DOI - PMC - PubMed
    1. 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. doi: 10.1002/art.21519. - DOI - PubMed

Associated data