Polymerized-type I collagen in small RA trial

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Polymerized-type I collagen in small RA trial

Jul 22, 2004 Veronique Duqueroy

Montreal, QC - Intramuscular (IM) polymerized type I collagen leads to

significant improvement in rheumatoid arthritis (RA) patients after 6-month

treatment, researchers from Mexico reported this week at the 12th

International Congress of Immunology and 4th Annual Conference of the

Federation of Clinical Immunology Societies (FOCIS) [1].

Previous studies in RA with collagen have used type 11 collagen, both bovine

and chicken, given orally to induce oral tolerance, but these studies have

produced conflicting results. One bovine product that was being developed

commercially (Colloral, Autoimmune Inc) was abandoned after pivotal phase 3

studies failed.

The Mexican researchers chose to use porcine type 1 collagen and linked it

to a polymer, polyvinylpyrrolidone (PVP). This collagen-PVP biodrug has

several advantages, lead investigator Dr Janette Furuzawa-Carballeda

(Instituto Nacional de Ciencias Medicas y Nutricion, Mexico City, Mexico)

told rheumawire. First, porcine type I collagen is the most similar to human

collagen. Second, telopeptideswhich are the most antigenic partshave been

removed; and finally, the polymerization of the collagen changes its

pharmacological proprieties and decreases its antigenicity, she added.

Collagen-PVP added onto methotrexate

The trial reported at the meeting was a double-blind placebo-controlled

study conducted in 30 patients with active RA already receiving methotrexate

for at least 3 months. Half of these patients had intramuscular injections

of 2-mL porcine type I collagen-PVP added to their regimen. The patients

were all women, with a mean age of 42.2 and 39.1 years old in the treated

and placebo groups, respectively.

After 6 months of treatment, " the collagen-PVP/MTX combination was more

efficacious than methotrexate alone, " Furuzawa-Carballeda told the meeting.

The patients treated with collagen-PVP had a statistically significant

improvement (p<0.05) in swollen joint count, Ritchie index (RI, 72-joint

count), morning stiffness, Spanish health assessment questionnaire (HAQ-DI),

disease activity score (DAS), rheumatoid factor (RF), and C-reactive protein

(CRP), as well as American College of Rheumatology (ACR) 20, 50, and 70.

Improvement in RA: collagen-PVP+MTX treated group vs placebo+MTX group

Collagen-PVP was well tolerated, and no adverse events were reported,

according to Furuzawa-Carballeda. There was no difference in the

liver-function tests or in urinary and blood analyses.

This study follows an open-label pilot trial published last year in which

Furuzawa-Carballeda et al tested subcutaneous (SC) administration of 0.2 mL

of the polymerized-type I collagen in 11 RA patients for 3 months [2]. The

subcutaneous injection was safe and well tolerated and led to significant

improvement for the patients according to the ACR criteria. " We think that

the SC injection has a more rapid effect, but the IM administration has a

more direct effect on systemic inflammation, " Furuzawa-Carballeda told

rheumawire. " That's why our next step will be to compare both methods of

administration. "