Session Information
Date: Tuesday, November 10, 2015
Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy Poster III
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose:
Although adrenocorticotropin
(ACTH) gel was approved by the FDA for the treatment of RA in 1952, data on its
clinical and structural benefits for the treatment of RA are limited. Emerging
evidence related to the melanocortin system suggests that mechanisms of ACTH
gel, in addition to steroidogenesis, may produce anti-inflammatory and
immunomodulatory effects,1 which can have a significant impact in
the management of inflammatory disorders such as RA. The objective of this study
was to evaluate the effects of ACTH gel on the widely accepted clinical and
structural endpoints in patients with early RA.
Methods: Fourteen patients with early RA, were
enrolled in a 24-week, open-label study using 15 mg methotrexate (MTX) weekly
and 80 U ACTH gel weekly or biweekly. Each subject had a minimum of 6 tender
and swollen joints, a Clinical Disease Activity Index (CDAI) score of >6.0 (with
a mean score of 39.3) and presence of at least 1 of the following: osteitis,
synovitis, or erosions on MRI (Esaote 0.3T) upon enrollment.
Results: We report interim results on 7 patients
dosed weekly and 7 patients dosed biweekly with 80 U ACTH gel. In the
biweekly-dosed group, all patients showed a clinical response, with an average
of 84% improvement in CDAI score after 6 months (Table 1). Two patients in this
group achieved remission, 3 low disease activity, and 2 medium disease
activity. In the weekly-dosed group, 5 of 7 patients showed a clinical
response, with a group average of 61.1% improvement in CDAI score after 6
months (Table 1). One patient remained at high disease activity and 1 patient
terminated early due to lack of efficacy. Taking into consideration both
groups, 12 of 14 patients showed a clinical response beginning at 3 months (71.2% CDAI improvement), which persisted through 6 months
of treatment (71.0% CDAI improvement).
Structural
MRI findings varied between treatment groups. In the biweekly-dosed group, 5
patients showed regression in synovitis, while 2 patients showed regression in
osteitis. In the weekly-dosed group, 3 patients showed regression in synovitis
and 3 patients showed regression in osteitis. Overall, erosions were unchanged
or regressed in 9 patients and progressed in 3 patients. No significant adverse
events were reported.
Conclusion: The results of this interim
analysis suggest a clinical and structural benefit with the use of ACTH gel in
combination with MTX in early RA. It appears that the biweekly-dosed group
obtained a more robust clinical and structural response; at 6 months this group
showed an improved, sustained outcome. These data suggest that use of ACTH gel may
result in a very effective treatment combination with MTX for early RA, possibly
reducing the need for step-up biologic therapy over time. Further research is
needed to determine if these results can be maintained on MTX therapy alone
after discontinuation of ACTH gel.
1.
Levine T, Drug
Des Devel Ther. 2012:6:131–139
To cite this abstract in AMA style:
Gaylis NB, Needell S, Sagliani J. The Effect of Adrenocorticotropin Gel (HP Acthar Gel) in Combination with MTX in Newly Diagnosed RA Patients from a Clinical and Structural Perspective [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/the-effect-of-adrenocorticotropin-gel-hp-acthar-gel-in-combination-with-mtx-in-newly-diagnosed-ra-patients-from-a-clinical-and-structural-perspective/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-effect-of-adrenocorticotropin-gel-hp-acthar-gel-in-combination-with-mtx-in-newly-diagnosed-ra-patients-from-a-clinical-and-structural-perspective/