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Abstract Number: 1946

Therapeutic Drug Monitoring Compared to Standard Infliximab Therapy in Patients with Immune-mediated Inflammatory Diseases: A Randomized Controlled Trial

Silje Watterdal Syversen1, Guro Goll1, Kristin Jørgensen2, Marthe Brun1, Øystein Sandanger3, Kristin Hammersbøen2, Joseph Sexton1, Inge Olsen3, Johanna Gehin4, David Warren3, Rolf Anton Klaasen3, Trude Bruun5, Maud Kristine Ljoså6, Anne Haugen7, Rune Njålla8, Brigitte Michelsen9, Camilla Zettel10, Yngvill Bragenes11, Svanaug Skorpe12, Eldri Strand13, Pawel Mielnik14, Cato Mørk15, Tore Kvien1, Jørgen Jahnsen2, Nils Bolstad16 and Espen Haavardsholm1, 1Diakonhjemmet Hospital, Oslo, Norway, 2Akershus University Hospital, Lørenskog, Norway, 3Oslo University Hospital, Oslo, Norway, 4Oslo University Hospital, Lillehammer, Nepal, 5The University Hospital of North Norway, Tromsø, Norway, 6Dept. of Rheumatology, Ålesund Hospital, Ålesund, Norway, 7Østfold Hospital Trust, Moss, Norway, 8Nordland Hospital Trust, Bodø, Bodø, Norway, 9Hospital of Southern Norway Trust, Kristiansand, Norway, 10Betanien Hospital, Skien, Norway, 11Vestre Viken Hospital Trust, Drammen, Norway, 12Haugesund Hospital for Rheumatic Diseases, Haugesund, Norway, 13Lillehammer Hospital for Rheumatic Diseases, Lillehammer, Norway, 14Førde Hospital Trust, Førde, Norway, 15Akershus Dermatology Center, Lørenskog, Norway, 16Oslo University Hospital, Radiumhospitalet, Oslo, Norway

Meeting: ACR Convergence 2021

Keywords: Anti-TNF Drugs, immunology, infliximab

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Session Information

Date: Tuesday, November 9, 2021

Session Title: Abstracts: Spondyloarthritis Including PsA – Treatment II: Biologic Therapies (1943–1946)

Session Type: Abstract Session

Session Time: 4:45PM-5:00PM

Background/Purpose: Proactive therapeutic drug monitoring (TDM), a treatment strategy based on scheduled assessments of serum drug levels, has been proposed to optimize efficacy and safety of infliximab and other TNF inhibitors. It is still unclear whether proactive TDM improves clinical outcomes. The NOR-DRUM trials (A and B) are the first randomized trials to assess the impact of proactive TDM of infliximab in a range of immune-mediated inflammatory diseases. The NOR-DRUM A trial focused on the induction phase of infliximab.1 The aim of the present trial, NOR-DRUM B, was to assess effectiveness of TDM during maintenance infliximab therapy.

Methods: In this 52-week randomized, open-label, multicentre trial, adult patients with rheumatoid arthritis (n=79), spondyloarthritis (n=138), psoriatic arthritis (n=53), ulcerative colitis (n=81), Crohns disease (n=66) or psoriasis (n=37) on infliximab therapy for a minimum of 30 weeks were randomly assigned 1:1 to infliximab based on TDM or standard therapy. In the TDM group, infliximab doses- and intervals were adjusted according to an algorithm to maintain serum infliximab levels within the prespecified therapeutic range 3-8 mg/L. In the standard therapy group, administration of infliximab was based on clinical judgement. The primary endpoint was sustained disease control without disease worsening. Disease worsening was defined by disease specific composite scores or a consensus on disease worsening between investigator and patient leading to major change in treatment. The primary analysis was performed by mixed effect logistic regression.

Results: Between June 7, 2017, and December 12, 2019, 458 patients were randomized and 454 received the allocated strategy and were included in the primary analyses. During the 52-week follow-up, the primary endpoint of sustained disease control without disease worsening was achieved in 167 (73.6 %) patients in the TDM group compared to 127 (55.9%) patients in the standard therapy group. The estimated adjusted difference was -17.6% (95% confidence interval -26.2 to -9.0, p=< 0.001). (Figure 1) Results were consistent in sensitivity analyses. The two groups were balanced regarding baseline characteristics (Table 1). Time to disease worsening was different in the two groups, hazard ratio (95% CI) 2.1 (1.5-2.9) (Figure 2). Secondary endpoints comparing disease activity and patient reported outcomes at week 52 did not show significant differences between the groups. Mean infliximab dose received during the trial was 4.8 mg/kg in both groups. Twenty-one (9.2%) in the TDM group and 27 (15.0 %) in the control group developed clinically significant levels of anti-drug antibodies. Adverse events were reported in 137 (60%) and 142 (63%) patients in the TDM and standard therapy groups, respectively.

Conclusion: Proactive TDM proved more effective than standard therapy in sustaining disease control without disease worsening. These results support implementation of proactive TDM as a general strategy during maintenance therapy with infliximab and have the potential to change clinical practice across specialities.

1Syversen SW et al. JAMA. 2021


Disclosures: S. Syversen, Thermo Fisher, 6; G. Goll, AbbVie, 1, 6, Pfizer, 1, 6, Boehringer Ingelheim, 6, Celltrion, 6, Sandoz, 6, Eli Lilly, 6, Roche, 6, Novartis, 6, Orion pharma, 6; K. Jørgensen, Celltrion, 6, AOP Orphan Pharmaceticals, 6, Norgine, 6; M. Brun, None; . Sandanger, None; K. Hammersbøen, None; J. Sexton, None; I. Olsen, None; J. Gehin, None; D. Warren, None; R. Klaasen, None; T. Bruun, None; M. Ljoså, None; A. Haugen, None; R. Njålla, None; B. Michelsen, Novartis, 5, Novartis, 1; C. Zettel, None; Y. Bragenes, None; S. Skorpe, None; E. Strand, None; P. Mielnik, None; C. Mørk, Novartis, 6, Leo Pharma, 6, Cellegene, 6, Abbvie, 6, Galderma, 6, UCB, 6; T. Kvien, Biogen, 6, Celltrion, 6, Egis, 6, Eli Lilly, 6, Evapharma, 6, Ewopharma, 6, Gilead, 6, Hikma, 6, Mylan, 6, Oktal, 6, Sandoz, 6, Sanofi, 6, Abbvie, 5, 6, BMS, 5, MSD, 5, Novartis, 5, 6, Pfizer, 5, 6, Amgen, 5, 6, UCB, 5; J. Jahnsen, None; N. Bolstad, None; E. Haavardsholm, Pfizer, 6, AbbVie, 2, 6, Celgene, 2, Janssen, 2, Gilead, 2, Eli-Lilly, 2, UCB, 2, 6, Novartis, 12, personal fees.

To cite this abstract in AMA style:

Syversen S, Goll G, Jørgensen K, Brun M, Sandanger , Hammersbøen K, Sexton J, Olsen I, Gehin J, Warren D, Klaasen R, Bruun T, Ljoså M, Haugen A, Njålla R, Michelsen B, Zettel C, Bragenes Y, Skorpe S, Strand E, Mielnik P, Mørk C, Kvien T, Jahnsen J, Bolstad N, Haavardsholm E. Therapeutic Drug Monitoring Compared to Standard Infliximab Therapy in Patients with Immune-mediated Inflammatory Diseases: A Randomized Controlled Trial [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/therapeutic-drug-monitoring-compared-to-standard-infliximab-therapy-in-patients-with-immune-mediated-inflammatory-diseases-a-randomized-controlled-trial/. Accessed May 30, 2023.
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