Mark C Genovese1, Michael E Weinblatt2, Philip J Mease3, Jacob A Aelion4,5, Paul M Peloso6, Kun Chen7, Yihan Li7, John Liu8, Ahmed A Othman9, Amit Khatri9, Heikki T Mansikka6, Piotr Leszczynski10. 1. Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, CA, USA. 2. Rheumatology, Brigham and Women's Hospital, Rheumatology, Boston, MA, USA. 3. Rheumatology and Internal Medicine, Swedish Medical Center and University of Washington, Seattle, WA, USA. 4. Arthritis Clinic, Jackson, USA. 5. Department of Medicine, University of Tennessee, Memphis, TN, USA. 6. Clinical Development, AbbVie Inc., North Chicago, IL, USA. 7. Data and Statistical Sciences, AbbVie Inc., North Chicago, IL, USA. 8. Medical Safety Evaluation Pharmacovigilance and Patient Safety, AbbVie Inc., North Chicago, IL, USA. 9. Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, IL, USA. 10. Rheumatology and Rehabilitation, Poznan University of Medical Sciences, Poznan, Poland.
Abstract
Objectives: To evaluate the safety and maintenance of efficacy with ABT-122, a bi-specific monoclonal antibody targeting TNF and IL-17A, in patients with RA or PsA in open-label, 24-week extensions [open-label extensions (OLEs)] of 12-week, randomized, double-blind studies. Methods: All patients received ABT-122 (RA, 120 mg; PsA, 240 mg) subcutaneously every other week on background MTX. Safety assessments included adverse events (AEs) and laboratory parameters. Efficacy was evaluated with ACR responses, 28-joint DAS using high-sensitivity CRP [DAS28 (hsCRP)], and Psoriasis Area and Severity Index (PsA study). Results: The RA OLE study enrolled 158 patients; the PsA OLE study enrolled 168 patients. In the RA OLE study, the incidence of treatment emergent AEs (TEAEs; 41%) appeared similar to the double-blind study (36-43%). In the PsA OLE study, 57% of patients reported ⩾1 TEAE (double-blind study, 42-53%). Most TEAEs were mild or moderate in severity. There were no neutrophil abnormalities greater than grade 2. Grade 3 and/or 4 laboratory abnormalities were reported for lymphocytes, alanine aminotransferase, aspartate aminotransferase, bilirubin and haemoglobin; the number of these severe laboratory values was low (0.6-3.0%), except grade 3 lymphocyte count decreased (11.5%) in the RA study. In both OLE studies, efficacy assessed by ACR responses and other disease activity scores was maintained over the 24 weeks. Conclusion: ABT-122 demonstrated acceptable tolerability and maintenance of efficacy for up to 36 weeks in patients with RA or PsA receiving background MTX. Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT02433340 and NCT02429895.
RCT Entities:
Objectives: To evaluate the safety and maintenance of efficacy with ABT-122, a bi-specific monoclonal antibody targeting TNF and IL-17A, in patients with RA or PsA in open-label, 24-week extensions [open-label extensions (OLEs)] of 12-week, randomized, double-blind studies. Methods: All patients received ABT-122 (RA, 120 mg; PsA, 240 mg) subcutaneously every other week on background MTX. Safety assessments included adverse events (AEs) and laboratory parameters. Efficacy was evaluated with ACR responses, 28-joint DAS using high-sensitivity CRP [DAS28 (hsCRP)], and Psoriasis Area and Severity Index (PsA study). Results: The RA OLE study enrolled 158 patients; the PsA OLE study enrolled 168 patients. In the RA OLE study, the incidence of treatment emergent AEs (TEAEs; 41%) appeared similar to the double-blind study (36-43%). In the PsA OLE study, 57% of patients reported ⩾1 TEAE (double-blind study, 42-53%). Most TEAEs were mild or moderate in severity. There were no neutrophil abnormalities greater than grade 2. Grade 3 and/or 4 laboratory abnormalities were reported for lymphocytes, alanine aminotransferase, aspartate aminotransferase, bilirubin and haemoglobin; the number of these severe laboratory values was low (0.6-3.0%), except grade 3 lymphocyte count decreased (11.5%) in the RA study. In both OLE studies, efficacy assessed by ACR responses and other disease activity scores was maintained over the 24 weeks. Conclusion:ABT-122 demonstrated acceptable tolerability and maintenance of efficacy for up to 36 weeks in patients with RA or PsA receiving background MTX. Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT02433340 and NCT02429895.
Authors: Philip J Mease; Mark C Genovese; Michael E Weinblatt; Paul M Peloso; Kun Chen; Ahmed A Othman; Yihan Li; Heikki T Mansikka; Amit Khatri; Neil Wishart; John Liu Journal: Arthritis Rheumatol Date: 2018-11 Impact factor: 10.995
Authors: Arthur Kavanaugh; Alice Gottlieb; Akimichi Morita; Joseph F Merola; Chen-Yen Lin; Julie Birt; Catherine L Shuler; Matthew M Hufford; Diamant Thaçi Journal: Ann Rheum Dis Date: 2019-05-21 Impact factor: 19.103
Authors: Mark C Genovese; Michael E Weinblatt; Jacob A Aelion; Heikki T Mansikka; Paul M Peloso; Kun Chen; Yihan Li; Ahmed A Othman; Amit Khatri; Nasser S Khan; Robert J Padley Journal: Arthritis Rheumatol Date: 2018-10-10 Impact factor: 10.995