Mallinckrodt (MNK) Presents Data on H.P. Acthar Gel Data in Corticosteroid; Strong Reduction Noted

November 17, 2016 4:32 PM EST

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Mallinckrodt plc (NYSE: MNK) presented results of a retrospective, claims-based analysis that indicated the use of H.P. Acthar Gel (repository corticotropin injection) may be associated with reductions in corticosteroid (CS) requirements among patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and dermatomyositis and polymyositis (DM/PM). The data was unveiled today at the 2016 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting Nov. 11-16 in Washington, D.C.

H.P. Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for use during an exacerbation or as maintenance therapy in select DM/PM or SLE patients. It is also approved as adjunctive therapy for short term administration in RA patients to tide patients over an acute episode or exacerbation.

The Mallinckrodt-sponsored analysis, titled "Effects of Repository Corticotropin Injection on Medication Use in Patients with Rheumatologic Conditions: A Claims Data Study" (abstract #2236), identified patients in the Symphony Health Solutions Patient Transactional Dataset from 2008 to 2015.

The study examined the demographics of those who used H.P. Acthar Gel and trends in other medications' use after H.P. Acthar Gel initiation (concomitant use), specifically prednisone – a corticosteroid – as well as other CS, biologics, non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying anti-rheumatic drugs (DMARDs), all of which were reported. Patients were followed for concomitant medication use from two years prior to and one year after H.P. Acthar Gel initiation. Paired two-tailed t-tests (a statistical test of differences) were used to calculate the p values for the use of each drug class before/after H.P. Acthar Gel initiation.

Study Results

Out of 2.7 million rheumatologic patients in the database reviewed over the six-year period, 2,749 patients used Acthar – 1,269 RA patients, 874 SLE patients and 606 with DM/PM. SLE patients were on average younger than RA and DM/PM patients, and most patients were female for all three conditions. The majority of patients received 80 units of H.P. Acthar Gel twice weekly.

The analysis identified 504 RA, 322 SLE, and 222 DM/PM patients with sufficient follow-up time to evaluate concomitant medication use following H.P. Acthar Gel treatment. For all three conditions, the proportions of patients who used any CS were significantly lower after H.P. Acthar Gel initiation. Specifically:

  • Their CS use was reduced from 67% pre-index to 54% post-index for RA, 73% to 58% for SLE and from 76% to 58% for DM/PM (for all comparisons: p < 0.05);
  • The proportions of patients who received biologics and DMARDs were also significantly lowered after Acthar initiation;
  • Among patients who had taken CS consistently for 24 weeks before H.P. Acthar Gel initiation, dose reductions (in percentages) were statistically significant for RA (28%), and trended lower without statistical significance for SLE (25%) and DM/PM (25%).

Study LimitationsLimitations of the retrospective analysis include uncertainties in diagnosis, medication use, and factors influencing medication changes. Additional limitations with a retrospective design also include the ability to make causal inferences, reproducibility and generalizability.

The abstract is currently available on the 2016 ACR/ARHP Annual Meeting website. The poster is available on the Mallinckrodt website.

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