PMID- 34919213
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220602
IS  - 2198-6576 (Print)
IS  - 2198-6584 (Electronic)
IS  - 2198-6576 (Linking)
VI  - 9
IP  - 2
DP  - 2022 Apr
TI  - Post Hoc Analysis of the Correlation Between Patient-Reported Outcomes and 
      Clinical Response to Repository Corticotropin Injection for Persistently Active 
      Rheumatoid Arthritis.
PG  - 435-446
LID - 10.1007/s40744-021-00412-x [doi]
AB  - PURPOSE: Approximately 6% of patients with rheumatoid arthritis (RA) in the USA 
      have refractory disease that is resistant to standard-of-care therapies. A recent 
      phase IV clinical trial affirmed the safety and efficacy of repository 
      corticotropin injection (RCI; Acthar(R) Gel) for refractory RA. This post hoc 
      analysis of the clinical trial data assessed whether changes in clinical measures 
      correlated with patient-reported outcome (PRO) improvements. METHODS: Data were 
      assessed from the trial's open-label period when patients received RCI (80 U) 
      twice weekly for 12 weeks. Clinical assessments included hemoglobin A1c, 
      C-reactive protein, erythrocyte sedimentation rate (ESR), total joint count 
      (TJC), swollen joint count (SJC), Disease Activity Score with 28 joint count and 
      ESR (DAS28-ESR), and Clinical Disease Activity Index (CDAI). PROs included pain 
      (Visual Analog Scale), fatigue (Functional Assessment of Chronic Illness 
      Therapy-Fatigue [FACIT-F]), disability (Health Assessment 
      Questionnaire-Disability Index [HAQ-DI]), and activity impairment (Work 
      Productivity and Activity Impairment [WPAI] questionnaire). Patients grouped by 
      minimal clinically important difference (MCID) improvement vs no improvement in 
      PROs were compared with clinical measures at week 12. Correlations were 
      determined by multivariable linear regression analysis and standardized 
      coefficient estimates. RESULTS: RCI responders, defined as patients with 
      DAS28-ESR < 3.2 at week 12, reported significantly greater PRO improvements for 
      pain, disability, fatigue, activity impairment, current work impairment, and 
      overall work impairment than nonresponders. Patients with MCID improvements in 
      all PROs showed significantly greater decreases in mean values for TJC, 
      DAS28-ESR, and CDAI, whereas those with pain, fatigue, and disability 
      improvements had significantly greater SJC and ESR reductions. Multivariable 
      linear regression analysis determined that improvement from baseline in all PROs 
      correlated with significant decreases in TJC, DAS28-ESR, and CDAI. ESR reduction 
      significantly correlated with improvements in pain and disability, but not 
      fatigue or WPAI. CONCLUSIONS: These results confirm that clinical responses to 
      RCI were directly correlated with patient perception of improvement.
CI  - (c) 2021. The Author(s).
FAU - Fleischmann, Roy
AU  - Fleischmann R
AUID- ORCID: 0000-0002-6630-1477
AD  - Metroplex Clinical Research Center, University of Texas Southwestern Medical 
      Center, 8144 Walnut Hill Lane, Dallas, TX, 75231, USA. rfleischmann@arthdocs.com.
FAU - Hayes, Kyle
AU  - Hayes K
AD  - Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.
FAU - Ahn, Sung-Woo
AU  - Ahn SW
AD  - KMK Consulting Inc, Morristown, NJ, USA.
FAU - Wan, George J
AU  - Wan GJ
AD  - Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.
FAU - Panaccio, Mary P
AU  - Panaccio MP
AD  - Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.
FAU - Karlsson, Daniel
AU  - Karlsson D
AD  - Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.
FAU - Furst, Daniel E
AU  - Furst DE
AD  - David Geffen School of Medicine, Division of Rheumatology, University of 
      California Los Angeles, Los Angeles, CA, USA.
LA  - eng
PT  - Journal Article
DEP - 20211217
PL  - England
TA  - Rheumatol Ther
JT  - Rheumatology and therapy
JID - 101674543
PMC - PMC8964863
OTO - NOTNLM
OT  - Acthar Gel
OT  - Patient-reported outcomes
OT  - RCI
OT  - Repository corticotropin injection
OT  - Rheumatoid arthritis
EDAT- 2021/12/18 06:00
MHDA- 2021/12/18 06:01
PMCR- 2021/12/17
CRDT- 2021/12/17 12:24
PHST- 2021/10/15 00:00 [received]
PHST- 2021/12/01 00:00 [accepted]
PHST- 2021/12/18 06:00 [pubmed]
PHST- 2021/12/18 06:01 [medline]
PHST- 2021/12/17 12:24 [entrez]
PHST- 2021/12/17 00:00 [pmc-release]
AID - 10.1007/s40744-021-00412-x [pii]
AID - 412 [pii]
AID - 10.1007/s40744-021-00412-x [doi]
PST - ppublish
SO  - Rheumatol Ther. 2022 Apr;9(2):435-446. doi: 10.1007/s40744-021-00412-x. Epub 2021 
      Dec 17.