ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0822

Local Tolerance of GP2017, an Adalimumab Biosimilar with Low Citrate Concentration Formulation, in Healthy Volunteers and Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Psoriasis

Piotr Wiland1, Andrew Blauvelt2, Lena Lemke3, Oliver von Richter4, Alison Balfour4, Fabricio Furlan4 and Norman Gaylis5, 1Department of Rheumatology and Internal Medicine, Medical University, Wroclaw, Poland, 2Oregon Medical Research Center, Portland, 3Hexal AG (A Sandoz company), Holzkirchen,Germany, Holzkirchen, Germany, 4Hexal AG (A Sandoz company), Holzkirchen, Germany, Holzkirchen, Germany, 5Arthritis and Rheumatic Disease Specialties, Aventura, FL

Meeting: ACR Convergence 2021

Keywords: , , ,

Session Information

Date: Sunday, November 7, 2021

Title: RA – Treatments Poster I: Comparative Effectiveness, Biosimilars, Withdrawal, & the Real World (0813–0845)

Session Type: Poster Session B

Session Time: 8:30AM-10:30AM

Background/Purpose: Adalimumab (ADL) can be self-administered every 2 weeks as a subcutaneous (s.c.) injection in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and psoriasis (PsO). Conflicting evaluations of local tolerance to formulations containing citrate buffer have created insecurity among health care professionals and patients.1,2 Here, we evaluated local tolerance of SDZ-ADL (GP2017) a biosimilar ADL with low citrate concentration (1.2 mM), in 466 healthy volunteers (HV) and 408 patients (RA: 177; PsO: 231 including PsA: 52) from 4 phase I pharmacokinetic and 2 phase III confirmatory studies.

Methods: HV evaluated their injection site pain (ISP) using a Visual Analog Scale (VAS) of 0–100 mm. HV received a single 40 mg/0.8 mL s.c. injection and patients received SDZ-ADL every 2 week during 48–51week duration of study. Injection site reactions (ISR) as well as adverse events were assessed by investigators during the clinical studies. Detailed study designs have been reported previously.3–6

Results: Overall, 456 (97.9%) HV did not experience ISR while 10 (2.1%) HV experienced ISR. These were mostly of mild intensity; only 1 (0.2%) had an ISR of moderate intensity. At 1-hour post-dose, 96.6% of HV experienced no pain (VAS score, 0–4 mm) (Figure). In the phase III studies, a low number of mild/moderate ISR/ISP events were observed, which further decreased during the study. Detailed results are presented in the Table. No ISR/ISP led to treatment or study discontinuation in any study.

Conclusion: The proportion of HV and patients experiencing ISR and ISP after administration of SDZ-ADL was low, with no events leading to treatment or study discontinuation. These outcomes challenge the clinical impact of citrate in ADL formulations on the incidence and intensity of ISP/ISR.

References:

  1. Nash P, et al. Rheumatol Ther. 2016; 3:257–70.
  2. NHS. Regional medicines optimisation committee briefing, best value biologicals: adalimumab update 6. July 2019. https://www.sps.nhs.uk/wp content/uploads/2019/07/Adalimumab-RMOC-Briefing-6.pdf.
  3. Blauvelt A, et al. Br J Dermatol. 2018; 179:623–31.
  4. Wiland P, et al. BioDrug. 2020; 34:809–23.
  5. von Richter O, et al. Expert Opin Biol Ther. 2019; 19:1057–64.
  6. von Richter O, et al. Expert Opin Biol Ther. 2019; 19:1075–83.

Figure: Proportion of HV with ISP in phase I PK studies

Table: ISP and ISR results from phase I PK and phase III confirmatory studies

Disclosures: P. Wiland, Celltrion, 1, Celgene, Eli Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, 1; A. Blauvelt, AbbVie, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, 1, Dermavant, Eli Lilly and Company, Evommune, Forte, Galderma, Incyte, Janssen, Leo,, 1, Novartis, Pfizer, Rapt, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, and UCB Pharma, 1; L. Lemke, Hexal AG, 3; O. von Richter, Hexal AG, 3; A. Balfour, Hexal AG, 3; F. Furlan, Hexal AG, 3; N. Gaylis, None.

To cite this abstract in AMA style:

Wiland P, Blauvelt A, Lemke L, von Richter O, Balfour A, Furlan F, Gaylis N. Local Tolerance of GP2017, an Adalimumab Biosimilar with Low Citrate Concentration Formulation, in Healthy Volunteers and Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Psoriasis [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/local-tolerance-of-gp2017-an-adalimumab-biosimilar-with-low-citrate-concentration-formulation-in-healthy-volunteers-and-patients-with-rheumatoid-arthritis-psoriatic-arthritis-and-psoriasis/. Accessed .

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