BACKGROUND: In a subgroup of patients with multiple sclerosis natalizumab therapy causes generation of anti-natalizumab antibodies that may be transient or persistent. It is recommended to discontinue natalizumab therapy in persistently antibody-positive patients. OBJECTIVE: To use titres of anti-natalizumab antibodies to predict persistency of antibodies. PATIENTS AND METHODS: In 525 consecutive natalizumab treated patients tested for anti-natalizumab antibodies 43 (8.2%) were antibody-positive. Thirty of the antibody-positive patients, who were tested both at three and at six months after treatment start, had antibody titres in blood measured using an extended ELISA method. RESULTS: Samples from persistently positive patients ( N =18) had higher titre values than samples from transiently positive patients ( N =12). A cut-off value for high titre values was generated, above which patients may discontinue natalizumab therapy after three months. The method had a sensitivity of 0.83, a specificity of 1.00 and a diagnostic accuracy of 0.90. CONCLUSION: An extended ELISA method for measuring anti-natalizumab antibody titres in multiple sclerosis patients on natalizumab therapy may be used for evaluation of antibody persistence. A test at three months may identify patients with high titres, who should discontinue natalizumab therapy, and patients with transient low-titre antibodies, who may continue natalizumab therapy despite development of antibodies.
BACKGROUND: In a subgroup of patients with multiple sclerosis natalizumab therapy causes generation of anti-natalizumab antibodies that may be transient or persistent. It is recommended to discontinue natalizumab therapy in persistently antibody-positive patients. OBJECTIVE: To use titres of anti-natalizumab antibodies to predict persistency of antibodies. PATIENTS AND METHODS: In 525 consecutive natalizumab treated patients tested for anti-natalizumab antibodies 43 (8.2%) were antibody-positive. Thirty of the antibody-positive patients, who were tested both at three and at six months after treatment start, had antibody titres in blood measured using an extended ELISA method. RESULTS: Samples from persistently positive patients ( N =18) had higher titre values than samples from transiently positive patients ( N =12). A cut-off value for high titre values was generated, above which patients may discontinue natalizumab therapy after three months. The method had a sensitivity of 0.83, a specificity of 1.00 and a diagnostic accuracy of 0.90. CONCLUSION: An extended ELISA method for measuring anti-natalizumab antibody titres in multiple sclerosispatients on natalizumab therapy may be used for evaluation of antibody persistence. A test at three months may identify patients with high titres, who should discontinue natalizumab therapy, and patients with transient low-titre antibodies, who may continue natalizumab therapy despite development of antibodies.
Authors: Zoé L E van Kempen; Johannis A van Rossum; Djoeke Doesburg; Iris Claessen; Annick de Vries; Anja Ten Brinke; Bob W van Oosten; Theo Rispens; Joep Killestein Journal: J Neurol Date: 2019-04-19 Impact factor: 4.849
Authors: Jenny Link; Ryan Ramanujam; Michael Auer; Malin Ryner; Signe Hässler; Delphine Bachelet; Cyprien Mbogning; Clemens Warnke; Dorothea Buck; Poul Erik Hyldgaard Jensen; Claudia Sievers; Kathleen Ingenhoven; Nicolas Fissolo; Raija Lindberg; Verena Grummel; Naoimh Donnellan; Manuel Comabella; Xavier Montalban; Bernd Kieseier; Per Soelberg Sørensen; Hans-Peter Hartung; Tobias Derfuss; Andy Lawton; Dan Sikkema; Marc Pallardy; Bernhard Hemmer; Florian Deisenhammer; Philippe Broët; Pierre Dönnes; Julie Davidson; Anna Fogdell-Hahn Journal: PLoS One Date: 2017-02-07 Impact factor: 3.240