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Abstract Details

Evaluation of Autoantibody Status Effect on Dermatomyositis Patients’ Response to IVIG Treatment: Post-hoc Analysis of the ProDERM Trial
Autoimmune Neurology
P4 - Poster Session 4 (11:45 AM-12:45 PM)
14-007

DM is an immune-mediated inflammatory myopathy with two subsets of autoantibodies identified in patients: myositis-specific antibodies (MSA) and myositis-associated antibodies (MAA). The randomized, placebo-controlled ProDERM study recently demonstrated the efficacy and safety of IVIG in DM patients.

To evaluate autoantibody status in patients with dermatomyositis (DM) and its relationship to treatment response to intravenous immunoglobulin (IVIG).

This was a post-hoc analysis of the ProDERM study. DM patients received 2 g/kg IVIG (n=47) or placebo (n=48) every 4 weeks for 16 weeks, then eligible patients (N=91) received IVIG through Week 40. Patient serum samples were analysed at baseline for MSA and MAA. Treatment response was evaluated by Total Improvement Score (TIS) at Weeks 16 and 40 (minimal response ≥20; moderate/major ≥40).

At baseline, 49 (52%) patients were MSA-positive (MSA+), 13 (14%) were MAA-positive (MAA+), and in 33 (35%) no antibodies (Ab-ve) were detected. Ten patients were both MSA+ and MAA+. In MSA+ patients (IVIG + placebo arms), 71% (35/49) had at least minimal response at Week 16, vs 55% (18/33) Ab-ve patients (p= 0.12) and 38% (5/13) who were MAA+ (p=0.03). In MSA+ patients on IVIG, 83% showed TIS response at Week 16 vs 60% on placebo (p=0.07). For all patients, no significant difference between the three antibody groups was seen in percentage of patients with ‘moderate/major improvement’ at Weeks 16 or 40. Analysis of individual autoantibodies showed no significant difference in response rates of Ab+ vs Ab-ve patients at Weeks 16 or 40 for anti-synthetase antibodies nor for anti-Mi2 antibodies. However, significantly more anti-TIF positive patients had a minimal response at Weeks 16 (p=0.02) and 40 (p=0.03) vs those who were negative.

IVIg appears to be an effective agent for treatment of dermatomyositis, regardless of autoantibody status of the patient.
Authors/Disclosures
Mazen M. Dimachkie, MD, FAAN (University of Kansas Medical Center)
PRESENTER
Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EcoR1 Capital, LLC. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cello Health BioConsulting, previously Defined Health. Dr. Dimachkie has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Dimachkie has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for CSL Behring. Dr. Dimachkie has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Octapharma. Dr. Dimachkie has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ArgenX. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Spark Therapeutics. Dr. Dimachkie has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for RAF-5. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Houston NeuroCare. Dr. Dimachkie has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Shire. Dr. Dimachkie has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Catalyst. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kezar. Dr. Dimachkie has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for RaPharma/UCB. Dr. Dimachkie has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for ArgenX. Dr. Dimachkie has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. An immediate family member of Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kezar. Dr. Dimachkie has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Catalyst. Dr. Dimachkie has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Takeda. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SCHOLAR Rock. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jenssen. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amazentis / Vandria. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Spark Therapeutics. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roivant. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SANEM. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medlink. Dr. Dimachkie has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for CSL Behring. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Third Rock. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Orphazyme . Dr. Dimachkie has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Astellas. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roivant . Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dianthus. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TACT / Treat NMD. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cabaletta Bio. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clinical Neurological Society of America, Inc . Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ig Society, Inc. Dr. Dimachkie has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abcuro. Dr. Dimachkie has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Covance / Labcorp. The institution of Dr. Dimachkie has received research support from CSL Behring. The institution of Dr. Dimachkie has received research support from Orphazyme. The institution of Dr. Dimachkie has received research support from FDA-OOPD. The institution of Dr. Dimachkie has received research support from NIH. Dr. Dimachkie has received intellectual property interests from a discovery or technology relating to health care. Dr. Dimachkie has received publishing royalties from a publication relating to health care.
Christina Charles-Schoeman (UCLA) No disclosure on file
Joachim Schessl No disclosure on file
Elisabeth Clodi, PhD (Octapharma Pharm. ProduduktionsgesmbH) Dr. Clodi has received personal compensation for serving as an employee of Octapharma Pharmazeutika Produktionsges.m.b.H..
Rohit Aggarwal, MD (Division of Rheumatology, University of Pittsburgh) Dr. Aggarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Kezar. Dr. Aggarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. Dr. Aggarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for AstraZeneca. Dr. Aggarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Aggarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Argenex. Dr. Aggarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BI. Dr. Aggarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Aggarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Q32. Dr. Aggarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Corbus. Dr. Aggarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Janssen. The institution of Dr. Aggarwal has received research support from Genentech. The institution of Dr. Aggarwal has received research support from Mallinckodt. The institution of Dr. Aggarwal has received research support from BMS. The institution of Dr. Aggarwal has received research support from EMD Serono. The institution of Dr. Aggarwal has received research support from Q32.