PMID- 30032191
OWN - NLM
STAT- MEDLINE
DCOM- 20190521
LR  - 20190521
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Linking)
VI  - 57
IP  - 11
DP  - 2018 Nov 1
TI  - Dual inhibition of tumour necrosis factor and interleukin-17A with ABT-122: 
      open-label long-term extension studies in rheumatoid arthritis or psoriatic 
      arthritis.
PG  - 1972-1981
LID - 10.1093/rheumatology/key173 [doi]
AB  - 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.
FAU - Genovese, Mark C
AU  - Genovese MC
AD  - Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, CA, 
      USA.
FAU - Weinblatt, Michael E
AU  - Weinblatt ME
AD  - Rheumatology, Brigham and Women's Hospital, Rheumatology, Boston, MA, USA.
FAU - Mease, Philip J
AU  - Mease PJ
AD  - Rheumatology and Internal Medicine, Swedish Medical Center and University of 
      Washington, Seattle, WA, USA.
FAU - Aelion, Jacob A
AU  - Aelion JA
AD  - Arthritis Clinic, Jackson, USA.
AD  - Department of Medicine, University of Tennessee, Memphis, TN, USA.
FAU - Peloso, Paul M
AU  - Peloso PM
AD  - Clinical Development, AbbVie Inc., North Chicago, IL, USA.
FAU - Chen, Kun
AU  - Chen K
AD  - Data and Statistical Sciences, AbbVie Inc., North Chicago, IL, USA.
FAU - Li, Yihan
AU  - Li Y
AD  - Data and Statistical Sciences, AbbVie Inc., North Chicago, IL, USA.
FAU - Liu, John
AU  - Liu J
AD  - Medical Safety Evaluation Pharmacovigilance and Patient Safety, AbbVie Inc., 
      North Chicago, IL, USA.
FAU - Othman, Ahmed A
AU  - Othman AA
AD  - Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, IL, USA.
FAU - Khatri, Amit
AU  - Khatri A
AD  - Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, IL, USA.
FAU - Mansikka, Heikki T
AU  - Mansikka HT
AD  - Clinical Development, AbbVie Inc., North Chicago, IL, USA.
FAU - Leszczynski, Piotr
AU  - Leszczynski P
AD  - Rheumatology and Rehabilitation, Poznan University of Medical Sciences, Poznan, 
      Poland.
LA  - eng
SI  - ClinicalTrials.gov/NCT02433340
SI  - ClinicalTrials.gov/NCT02429895
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
RN  - 0 (ABT-122)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (IL17A protein, human)
RN  - 0 (Immunoglobulins)
RN  - 0 (Interleukin-17)
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antirheumatic Agents/*therapeutic use
MH  - Arthritis, Psoriatic/diagnosis/*drug therapy
MH  - Arthritis, Rheumatoid/diagnosis/*drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Immunoglobulins/*therapeutic use
MH  - Interleukin-17/*antagonists & inhibitors
MH  - Male
MH  - Methotrexate/therapeutic use
MH  - Middle Aged
MH  - Severity of Illness Index
MH  - Treatment Outcome
MH  - Tumor Necrosis Factor-alpha/*antagonists & inhibitors
EDAT- 2018/07/23 06:00
MHDA- 2019/05/22 06:00
CRDT- 2018/07/23 06:00
PHST- 2017/12/14 00:00 [received]
PHST- 2018/07/23 06:00 [pubmed]
PHST- 2019/05/22 06:00 [medline]
PHST- 2018/07/23 06:00 [entrez]
AID - 5055881 [pii]
AID - 10.1093/rheumatology/key173 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2018 Nov 1;57(11):1972-1981. doi: 
      10.1093/rheumatology/key173.