Abatacept Population Pharmacokinetics and Exposure-Response Analyses for Dose Recommendation of SC and IV Abatacept in Patients With Psoriatic Arthritis

Authors: Li X, Passarell JA, Morris D, Murthy B, Girgis IG
Conference: ASCPT
Keywords: abatacept population pharmacokinetics, drug dosage, psoriatic arthritis
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Introduction

  • Both subcutaneous (SC) and intravenous (IV) abatacept, a selective T-cell co-stimulation modulator, are approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) and pediatric patients with moderately to severely active polyarticular-course juvenile idiopathic arthritis (pJIA) .1
  •  Abatacept has a mechanism of action that is fundamentally different from that of other biologic disease-modifying antirheumatic drugs (bDMARDs), and has proven efficacy and a good safety profile in psoriatic arthritis (PsA).2,3
  • The exposure–response (E–R) relationship established in RA and pJIA has demonstrated that a steady-state trough concentration (Cminss) threshold of 10 μg/mL provides a near-maximal efficacy response.4
  • For PsA, abatacept is approved as either weight-tiered IV (~10 mg/kg/month) or fixed-dose SC (125 mg/week) treatment:
    • in the US, for the treatment of adults with active disease1
    • in the EU, either alone or in combination with methotrexate (MTX), for the treatment of active PsA in adult patients when response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required.5

American Society for Clinical Pharmacology & Therapeutics, March 21-24, 2018, Orlando, Florida

By Julie A Passarell, Denise Morris