PMID- 32497440
OWN - NLM
STAT- MEDLINE
DCOM- 20210127
LR  - 20220416
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 19
IP  - 8
DP  - 2020 Aug
TI  - Safety of repository corticotropin injection as an adjunctive therapy for the 
      treatment of rheumatoid arthritis.
PG  - 935-944
LID - 10.1080/14740338.2020.1779219 [doi]
AB  - INTRODUCTION: Disease-modifying antirheumatic drugs (DMARDs) have significantly 
      improved clinical symptoms and quality of life with reduced disease progression 
      in many patients with rheumatoid arthritis (RA). Short-term glucocorticoid 
      therapy is often used initially in combination with DMARDs, but some patients 
      still have difficulty reaching treatment goals. Repository corticotropin 
      injection (RCI, Acthar(R) Gel) is approved as adjunctive therapy for short-term 
      administration in patients with continued RA disease activity. AREAS COVERED: To 
      determine the safety of RCI in the treatment of RA, adverse events (AEs) from a 
      recent clinical trial of RCI as an adjunctive therapy along with DMARDs and 
      glucocorticoids (ClinicalTrials.gov identifier NCT02919761) were compared with 
      AEs reported in randomized clinical trials of DMARDs and glucocorticoids alone. A 
      systematic review of the literature yielded 4 articles describing the detailed 
      safety results of DMARD/glucocorticoid combination therapy used in the treatment 
      of RA for comparison. EXPERT OPINION: There were no clinically significant 
      differences between the AE profiles of RCI/DMARD/glucocorticoid treatment in the 
      RCI clinical trial and those in the DMARD/glucocorticoid safety profile compiled 
      from the reviewed clinical trials; this was supported by pharmacovigilance data. 
      These results support the short-term safety of RCI as an adjunctive therapy for 
      patients with persistently active RA.
FAU - Fleischmann, Roy
AU  - Fleischmann R
AD  - Metroplex Clinical Research Center, University of Texas Southwestern Medical 
      Center , Dallas, TX, 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
SI  - ClinicalTrials.gov/NCT02919761
PT  - Comparative Study
PT  - Journal Article
PT  - Systematic Review
DEP - 20200616
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Gels)
RN  - 0 (Glucocorticoids)
RN  - 9002-60-2 (Adrenocorticotropic Hormone)
SB  - IM
MH  - Adrenocorticotropic Hormone/*administration & dosage/adverse effects
MH  - Antirheumatic Agents/*administration & dosage/adverse effects
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Disease Progression
MH  - Drug Therapy, Combination
MH  - Gels
MH  - Glucocorticoids/administration & dosage/adverse effects
MH  - Humans
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
OTO - NOTNLM
OT  - Acthar Gel
OT  - DMARD
OT  - adverse event
OT  - disease-modifying antirheumatic drugs
OT  - glucocorticoids
OT  - repository corticotropin injection
OT  - rheumatoid arthritis
OT  - safety
EDAT- 2020/06/05 06:00
MHDA- 2021/01/28 06:00
CRDT- 2020/06/05 06:00
PHST- 2020/06/05 06:00 [pubmed]
PHST- 2021/01/28 06:00 [medline]
PHST- 2020/06/05 06:00 [entrez]
AID - 10.1080/14740338.2020.1779219 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2020 Aug;19(8):935-944. doi: 10.1080/14740338.2020.1779219. 
      Epub 2020 Jun 16.