PMID- 30233812
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220322
IS  - 2056-5933 (Print)
IS  - 2056-5933 (Electronic)
IS  - 2056-5933 (Linking)
VI  - 4
IP  - 2
DP  - 2018
TI  - Ixekizumab is efficacious when used alone or when added to conventional synthetic 
      disease-modifying antirheumatic drugs (cDMARDs) in patients with active psoriatic 
      arthritis and previous inadequate response or intolerance to tumour necrosis 
      factor inhibitors.
PG  - e000692
LID - 10.1136/rmdopen-2018-000692 [doi]
LID - e000692
AB  - OBJECTIVE: To conduct subset analyses of SPIRIT-P2 (Standard Protocol Items: 
      Recommendations for Interventional Trials, NCT02349295) to investigate the 
      efficacy and safety of ixekizumab versus placebo in three subgroups of patients 
      with active psoriatic arthritis (PsA) according to the concomitant conventional 
      synthetic disease-modifying antirheumatic drug (cDMARD) received: any background 
      cDMARDs (including methotrexate), background methotrexate only. METHODS: Patients 
      were randomised to receive placebo, ixekizumab 80 mg every 4 weeks (IXEQ4W) or 
      every 2 weeks (IXEQ2W). Efficacy and safety were assessed when patients were 
      subdivided according to cDMARD use at baseline. Efficacy was evaluated versus 
      placebo at week 24 by the American College of Rheumatology criteria (ACR20/50), 
      achievement of minimal disease activity (MDA) state, DiseaseActivityIndex for PsA 
      (DAPSA), 28-joint DiseaseActivityScore using C reactive protein (DAS28-CRP), 
      HealthAssessmentQuestionnaire-Disability Index and the 36-item Short-Form health 
      survey physical functioning domain. RESULTS: Regardless of background cDMARD 
      status, ACR20, ACR50 and MDA response rates were significantly higher than 
      placebo with IXEQ4W or IXEQ2W treatment. Similarly, significant improvements were 
      observed relative to placebo for DAS28-CRP and DAPSA across subgroups. Physical 
      function also significantly improved relative to placebo with IXEQ4W treatment 
      regardless of background cDMARD status and with IXEQ2W alone. Percentages of 
      reported treatment emergent adverse events (AEs), serious AEs (including serious 
      infections) and discontinuations due to AEs in each subgroup were comparable to 
      the overall SPIRIT-P2 population. CONCLUSION: Ixekizumab was efficacious in 
      patients with active PsA and previous tumour necrosis factor inhibitor 
      (TNFi)inadequate response or TNFi intolerance treated with ixekizumab alone or 
      when added to cDMARDswith subgroup safety profiles that were consistent with that 
      observed in the overall SPIRIT-P2 population.
FAU - Nash, Peter
AU  - Nash P
AD  - Department of Medicine, University of Queensland, Brisbane, Queensland, 
      Australia.
FAU - Behrens, Frank
AU  - Behrens F
AD  - Center for Innovative Diagnostics and Therapy in Rheumatology/Immunology (CIRI), 
      Goethe University Frankfurt and Fraunhofer IME Project Group Translational 
      Medicine and Pharmacology TMP, Frankfurt, Germany.
FAU - Orbai, Ana-Maria
AU  - Orbai AM
AD  - Division of Rheumatology, John Hopkins University School of Medicine, Baltimore, 
      Maryland, USA.
FAU - Rathmann, Suchitrita S
AU  - Rathmann SS
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Adams, David H
AU  - Adams DH
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Benichou, Olivier
AU  - Benichou O
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Deodhar, Atul
AU  - Deodhar A
AD  - Division of Arthritis and Rheumatic Diseases, Department of Medicine, Oregon 
      Health and Science University, Portland, Oregon, USA.
LA  - eng
PT  - Journal Article
DEP - 20180907
PL  - England
TA  - RMD Open
JT  - RMD open
JID - 101662038
EIN - RMD Open. 2019 Feb 18;5(1):e000692corr1. PMID: 30886737
PMC - PMC6135452
OTO - NOTNLM
OT  - *DMARDs (biologic)
OT  - *DMARDs (synthetic)
OT  - *methotrexate
OT  - *psoriatic arthritis
COIS- Competing interests: PN: Grant/research support from: AbbVie, Amgen, 
      Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, 
      Novartis, Pfizer, Roche, Sanofi, UCB; Consultant for: AbbVie, Amgen, 
      Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, 
      Novartis, Pfizer, Roche, Sanofi, UCB; Speakers bureau: AbbVie, Amgen, 
      Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, 
      Novartis, Pfizer, Roche, Sanofi, UCB. FB: Grant/research support from: Abbvie, 
      Pfizer, Roche, Chugai, Prophylix, Novartis, Iron4U; Consultant for: Abbvie, 
      Pfizer, Roche, Chugai, UCB, BMS, Celgene, MSD, Novartis, Biotest, Janssen, 
      Genzyme, Sanofi, Lilly, Sandoz; Speakers bureau: Abbvie, Pfizer, Roche, Chugai, 
      UCB, BMS, Celgene, MSD, Novartis, Biotest, Janssen, Genzyme, Sanofi, Lilly, 
      Sandoz. A-MO: Grant/research support from: Abbvie, Celgene, Eli Lilly and 
      Company, Horizon, Janssen, Novartis, Pfizer; Consultant for: Eli Lilly and 
      Company, Janssen, Novartis, Pfizer, UCB. SSR, DHA, OB: All employees and 
      shareholders of Eli Lilly and Company. AD: Grant/research support from: Pfizer; 
      Consultant for: Pfizer.
EDAT- 2018/09/21 06:00
MHDA- 2018/09/21 06:01
PMCR- 2018/09/07
CRDT- 2018/09/21 06:00
PHST- 2018/04/01 00:00 [received]
PHST- 2018/06/29 00:00 [revised]
PHST- 2018/07/06 00:00 [accepted]
PHST- 2018/09/21 06:00 [entrez]
PHST- 2018/09/21 06:00 [pubmed]
PHST- 2018/09/21 06:01 [medline]
PHST- 2018/09/07 00:00 [pmc-release]
AID - rmdopen-2018-000692 [pii]
AID - 10.1136/rmdopen-2018-000692 [doi]
PST - epublish
SO  - RMD Open. 2018 Sep 7;4(2):e000692. doi: 10.1136/rmdopen-2018-000692. eCollection 
      2018.