Mallinckrodt announces new clinical data evaluating acthar® gel (repository corticotropin injection) in rheumatoid arthritis (ra) at the 2019 american college of rheumatology/association of rheumatology professionals (acr/arp) annual meeting

Mallinckrodt plc announced data on patient-reported outcomes (pros) showing acthar® gel (repository corticotropin injection) improved disease measures that impact rheumatoid arthritis (ra) patients with persistently active disease, as well as new data from an exploratory analysis. the data originate from new analyses from mallinckrodt's phase 4 study of acthar gel in ra patients with persistently active disease and was recently presented at the 2019 american college of rheumatology/association of rheumatology professionals (acr/arp) annual meeting, held nov. 8-13 in atlanta. acthar gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. acthar gel is approved by the u.s. food and drug administration (fda) as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in ra, including juvenile ra (selected cases may require low-dose maintenance therapy).1 please see important safety information for acthar gel below. new data from the company's two-part phase 4 multicenter, placebo-controlled study assessing the efficacy and safety of acthar gel in patients with persistently active ra who were previously treated with disease-modifying anti-rheumatic drugs (dmards) and corticosteroids showed that acthar gel treatment significantly improved patient-reported pain, fatigue, physical functioning and work-related impairment as early as week 4, and resulted in clinically meaningful improvements in pros. the analysis examined pro measures as a secondary endpoint from part 1 of the study, the 12-week open-label period, and assessed mean changes at baseline and at weeks 4, 8 and 12. study limitations: sample bias may exist for the open-label phase of the ongoing study, and patients were aware that they were receiving acthar gel. examiner bias may also exist as the patient had to reach low disease activity in order to enter the second phase of the study. the results cannot be solely attributed to acthar gel since patients were on different medications at the start of the trial and no washout periods were undertaken. a new exploratory analysis from the phase 4 ra study assessed bone markers associated with bone loss to evaluate the impact of acthar gel treatment on bone turnover in patients with persistently active ra. bone and cartilage biomarker levels were evaluated throughout the study, at baseline and weeks 12 and 24 and included: c-terminal cross-linking telopeptide (ctx), c-terminal cross-linking telopeptide of type i collagen (ctx-i), osteoprotegrin (opg), n-terminal propeptide of type i collagen (pinp), and soluble receptor activator of nuclear factor kappa-ss ligand (srankl) and cartilage degradation biomarkers (c-terminal cross-linking telopeptide of type ii collagen (ctx-ii) and ctx-ii creatinine (crt). at week 12, the open-label period, significant decreases in mean levels of the bone turnover biomarker pinp (p<0.01) and mean levels of cartilage degradation biomarkers ctx-ii (p<0.01) and ctx-ii crt (p<0.001) were observed. at week 24, the end of the study's double-blind period, there was a significant increase from baseline in mean srankl levels at both week 12 and week 24 (p<0.05) compared to placebo, suggesting a potential increase in osteoclast differentiation. mean levels of all other bone and cartilage biomarkers remained stable at all time points and markers of bone degeneration remained stable. acthar gel is an injectable drug approved by the fda for the treatment of 19 indications. of these, the majority of acthar use is in these indications: adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). the treatment of symptomatic sarcoidosis. monotherapy for the treatment of infantile spasms in infants and children under 2 years of age. treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus. the treatment of acute exacerbations of multiple sclerosis in adults. controlled clinical trials have shown acthar gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. however, there is no evidence that it affects the ultimate outcome or natural history of the disease. inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus. treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis). treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.
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