AB0208 DO LOW CONCENTRATIONS OF CITRATE IN AN ADALIMUMAB FORMULATION IMPACT THE INCIDENCE AND/OR INTENSITY OF INJECTION SITE PAIN? DATA FROM PHASE I AND III STUDIES ASSESSING THE LOCAL TOLERANCE OF GP2017 (ADALIMUMAB BIOSIMILAR, SDZ-ADL) IN HEALTHY VOLUNTEERS, RHEUMATOID ARTHRITIS, AND PSORIASIS PATIENTS

Background: Adalimumab (ADL) is typically self-administered every 2 weeks (W) as a subcutaneous (s.c.) injection by patients (pts) for diverse indications, including rheumatoid arthritis (RA), psoriatic (PsA), and psoriasis (PsO). Conflicting evaluations of local tolerance to formulations containing citrate buffer have created insecurities among health care professionals pts. 1,2 Objectives: To evaluate SDZ-ADL (GP2017), biosimilar ADL with low concentration (1.2 mM), 3 in 466 healthy volunteers (HV) 408 pts (RA: 177 PsO: 231 PsA: 52) from four phase I pharmacokinetic (PK) two III confirmatory studies. Methods: HV evaluated their site pain (ISP) using Visual Analogue Scale (VAS) 0–100 mm. received single 40 mg/0.8 mL s.c. 2W during 48–51W duration study. Injection reactions (ISR) well adverse events (AEs) were assessed investigators the clinical Details study designs been reported previously. 4–7 Results: Overall, 456 (97.9%) experienced no ISR. Ten These mostly mild intensity; only 1 (0.2%) had an ISR moderate intensity. 96.6% (VAS score 0–4 mm) 8 at 1-hour post-dose (Figure 1). In studies, number ISR/ISP observed, which decreased course Detailed results are provided Table 1. No led treatment or discontinuation any Conclusion: The proportion experiencing ISP after administration was low, leading discontinuation. call into question impact its on incidence intensity ISP. References: [1]Nash 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] https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761071lbl.pdf [4]Blauvelt A, Br J Dermatol 2018;179:623–31. [5]Wiland P, BioDrugs 2020;34:809–23. [6]Richter OV, Expert Opin Biol 2019;19:1057–64. [7]Richter 2019;19:1075–83. [8]Hawker GA, Arthritis Care Res 2011;63:240–52. Figure Proportion PK studies Phase Study 101 (N=73 ) 102 (N=108 103 (N=178 104 (N=107 Pooled (N=466 VAS scores (mm) Mean (SD) 0.89 (2.07) 0.07 (0.52) 1.03 (1.71) (2.49) 0.79 (1.84) Median 0 post-dose, n (% None 73 (100) 106 (98.2) 178 99 (92.5) (97.9) Mild (0) (0.9) (7.5) 9 (1.9) Moderate (0.2) ADACCESS 5 * (PsO PsA ADMYRA 6 (RA W0–17 (N=231) W0–51 (N=168; re-randomised continue W17) W0–24 (N=177) W0–48 (N=177; all continued W24) Dosage Induction 80 mg W0, then EoW duration, W 17 51 24 48 AEs - ISR, (%), 15 (6.5), 34 (5.4), 26 7 (4.0), 11 12 14 (6.1), 30 (0.4), 4 (reported ISR), (1.3) (0.6) (1.1) *ADACCESS switch therefore, exposed throughout period included here. EoW, other week, N, Disclosure Interests: Piotr Wiland Speakers bureau: Celltrion, Celgene, Eli Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, Consultant of: Andrew Blauvelt AbbVie, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Lilly Company, Evommune, Forte, Galderma, Incyte, Janssen, Leo, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, UCB Pharma., Lena Lemke Employee Hexal AG, Oliver von Richter Alison Balfour Fabricio Furlan Norman Gaylis: declared