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A single intradermal injection of autologous modified dendritic cells exposed to citrullinated peptides is safe and has immunoregulatory and anti-inflammatory effects, results of a phase I first in-human trial showed.
Dr. Helen Benham of the University of Queensland Diamantina Institute, Woolloongabba, Australia, and her colleagues gave 34 anticitrullinated peptide antibody (ACPA)-positive RA patients carrying HLA-DRB1 shared epitope alleles the immunotherapy treatment Rheumavax at either a high or low dose. They then compared results 1 month after treatment with 16 RA patients who served as controls.
Patients who received the treatment had a reduced number of effector T cells and a decreased production of proinflammatory cytokines, compared with controls, the researchers reported (Sci. Transl. Med. 2015;7:290ra87 [doi: 10.1126/scitranslmed.aaa9301]).
Rheumavax did not induce disease flares in patients recruited with minimal disease activity, and the 28-joint disease activity score (DAS28) decreased in treated patients with active disease. Adverse events were a grade 1 out of a maximum of 4 and were similar between the low- and high-dose groups.
“The exploratory study demonstrates safety and biological activity of a single intradermal injection of autologous modified dendritic cells exposed to citrullinated peptides and provides rationale for further studies to assess clinical efficacy and antigen specific effects of autoantigen immunomodulatory therapy in RA,” concluded senior investigator Ranjeny Thomas, also of the University of Queensland, and associates.
All of the study patients were being treated with disease-modifying antirheumatic drugs. Median disease duration in the low-dose group was 3 years and baseline DAS28 based on C-reactive protein was 2.43. The high-dose group had a median disease duration of 2 years and a DAS28-CRP score of 2.2.
The authors reported no conflicts of interest.
rhnews@frontlinemedcom.com
A single intradermal injection of autologous modified dendritic cells exposed to citrullinated peptides is safe and has immunoregulatory and anti-inflammatory effects, results of a phase I first in-human trial showed.
Dr. Helen Benham of the University of Queensland Diamantina Institute, Woolloongabba, Australia, and her colleagues gave 34 anticitrullinated peptide antibody (ACPA)-positive RA patients carrying HLA-DRB1 shared epitope alleles the immunotherapy treatment Rheumavax at either a high or low dose. They then compared results 1 month after treatment with 16 RA patients who served as controls.
Patients who received the treatment had a reduced number of effector T cells and a decreased production of proinflammatory cytokines, compared with controls, the researchers reported (Sci. Transl. Med. 2015;7:290ra87 [doi: 10.1126/scitranslmed.aaa9301]).
Rheumavax did not induce disease flares in patients recruited with minimal disease activity, and the 28-joint disease activity score (DAS28) decreased in treated patients with active disease. Adverse events were a grade 1 out of a maximum of 4 and were similar between the low- and high-dose groups.
“The exploratory study demonstrates safety and biological activity of a single intradermal injection of autologous modified dendritic cells exposed to citrullinated peptides and provides rationale for further studies to assess clinical efficacy and antigen specific effects of autoantigen immunomodulatory therapy in RA,” concluded senior investigator Ranjeny Thomas, also of the University of Queensland, and associates.
All of the study patients were being treated with disease-modifying antirheumatic drugs. Median disease duration in the low-dose group was 3 years and baseline DAS28 based on C-reactive protein was 2.43. The high-dose group had a median disease duration of 2 years and a DAS28-CRP score of 2.2.
The authors reported no conflicts of interest.
rhnews@frontlinemedcom.com
A single intradermal injection of autologous modified dendritic cells exposed to citrullinated peptides is safe and has immunoregulatory and anti-inflammatory effects, results of a phase I first in-human trial showed.
Dr. Helen Benham of the University of Queensland Diamantina Institute, Woolloongabba, Australia, and her colleagues gave 34 anticitrullinated peptide antibody (ACPA)-positive RA patients carrying HLA-DRB1 shared epitope alleles the immunotherapy treatment Rheumavax at either a high or low dose. They then compared results 1 month after treatment with 16 RA patients who served as controls.
Patients who received the treatment had a reduced number of effector T cells and a decreased production of proinflammatory cytokines, compared with controls, the researchers reported (Sci. Transl. Med. 2015;7:290ra87 [doi: 10.1126/scitranslmed.aaa9301]).
Rheumavax did not induce disease flares in patients recruited with minimal disease activity, and the 28-joint disease activity score (DAS28) decreased in treated patients with active disease. Adverse events were a grade 1 out of a maximum of 4 and were similar between the low- and high-dose groups.
“The exploratory study demonstrates safety and biological activity of a single intradermal injection of autologous modified dendritic cells exposed to citrullinated peptides and provides rationale for further studies to assess clinical efficacy and antigen specific effects of autoantigen immunomodulatory therapy in RA,” concluded senior investigator Ranjeny Thomas, also of the University of Queensland, and associates.
All of the study patients were being treated with disease-modifying antirheumatic drugs. Median disease duration in the low-dose group was 3 years and baseline DAS28 based on C-reactive protein was 2.43. The high-dose group had a median disease duration of 2 years and a DAS28-CRP score of 2.2.
The authors reported no conflicts of interest.
rhnews@frontlinemedcom.com
FROM SCIENCE TRANSLATIONAL MEDICINE
Key clinical point: A single intradermal injection of autologous modified dendritic cells exposed to citrullinated peptides was safe and had immunoregulatory and anti-inflammatory effects in HLA risk genotype–positive RA patients.
Major finding: Patients who received Rheumavax treatment had a reduced number of effector T cells and a decreased production of proinflammatory cytokines 1 month after treatment, compared with controls.
Data source: Single-center, open-label, first in-human phase I study of 34 ACPA-positive RA patients and 16 control RA patients.
Disclosures: The authors reported no conflicts of interest.
