Percentage of anti-CD4 monoclonal antibody-coated lymphocytes in the rheumatoid joint is associated with clinical improvement. Implications for the development of immunotherapeutic dosing regimens

Arthritis Rheum. 1996 Jan;39(1):52-6. doi: 10.1002/art.1780390107.


Objective: We assessed the effect of a daily dosing schedule of the chimeric anti-CD4 monoclonal antibody (MAb), cM-T412, in rheumatoid arthritis (RA) patients, and compared lymphocyte changes in the peripheral blood (PB) and synovial fluid (SF) of these patients.

Methods: Twelve patients received 50 mg/day of cM-T412 for 5 days, followed by a maintenance treatment of 50 mg/week for 5 weeks (6 patients), or a retreatment course of 50 mg/day for 5 days after 5 weeks (6 patients). Paired PB and SF samples were obtained during treatment for analysis.

Results: Changes in lymphocyte count and coating with the MAb in PB did not reflect changes in the SF. After 5 daily treatments, the percentage of cM-T412-coated CD4+ lymphocytes in SF correlated with the degree of clinical improvement seen in patients at 2 weeks after the initiation of therapy (r = 0.75, P < 0.05).

Conclusion: These results demonstrate the importance of antibody dosage and treatment regimen in determining clinical benefit. Our findings suggest that the percentage of cM-T412-coated CD4+ lymphocytes in SF may be a predictor of clinical outcome.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal / therapeutic use*
  • Arthritis, Rheumatoid / blood*
  • Arthritis, Rheumatoid / complications
  • Arthritis, Rheumatoid / therapy*
  • CD4 Antigens / immunology*
  • CD4 Lymphocyte Count
  • CD4-Positive T-Lymphocytes*
  • Drug Administration Schedule
  • Humans
  • Middle Aged
  • Synovial Fluid / cytology*
  • Time Factors
  • Treatment Outcome


  • Antibodies, Monoclonal
  • CD4 Antigens