StemCell Therapy

INTRODUCTION:

The objective of this study was to assess efficacy and safety of repository corticotropin injection (RCI) in subjects with activerheumatoid arthritis(RA) despite treatment with a corticosteroid and one or two disease-modifying antirheumatic drugs (DMARDs).

All subjects received open-label RCI (80 U) twice weekly for 12weeks (part 1); only those with low disease activity [LDA; i.e., Disease Activity Score 28 joint count and erythrocyte sedimentation rate (DAS28-ESR)<3.2] were randomly assigned to receive either RCI (80 U) or placebo twice weekly during the 12-week double-blind period (part 2). The primary efficacy endpoint was the proportion of subjects who achieved LDA at week 12. Secondary efficacy endpoints included proportions of subjects who maintained LDA during weeks 12 through 24 and achieved Clinical Disease Activity Index (CDAI)10 at weeks 12 and 24. Safety was assessed via adverse event reports.

Of the 259 enrolled subjects, 235 completed part 1; 154 subjects (n=77 each for RCI and placebo) entered part 2, and 127 (RCI, n=71; placebo, n=56) completed. At week 12, 163 subjects (62.9%) achieved LDA and 169 (65.3%) achieved CDAI10 (both p<0.0001). At week 24, 47 (61.0%) RCI-treated and 32 (42.1%) placebo-treated subjects maintained LDA (p=0.019); 66 (85.7%) RCI-treated and 50 (65.8%) placebo-treated subjects maintained CDAI10 (p=0.004). No unexpected safety signals were observed.

RCI was effective and generally safe in patients with active RA despite corticosteroid/DMARD therapy. By week 12,>60% of patients achieved LDA, which was maintained with 12 additional weeks of treatment. Most patients who achieved LDA maintained it for 3months after RCI discontinuation.

Clinicaltrials.gov identifierNCT02919761.

See more here:
Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial - DocWire...

This entry was posted on March 20, 2020 at 8:48 pm and is filed under Arthritis. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |