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Blood, 15 March 2001, Vol. 97, No. 6, pp. 1590-1597
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Treatment of B-lymphoproliferative disorder with a monoclonal
anti-interleukin-6 antibody in 12 patients: a multicenter phase 1-2 clinical trial
Elie Haddad,
Sophie Paczesny,
Veronique Leblond,
Jean-Marie Seigneurin,
Marc Stern,
Antoine Achkar,
Marc Bauwens,
Vincent Delwail,
Dominique Debray,
Christophe Duvoux,
Philippe Hubert,
Bruno Hurault de Ligny,
John Wijdenes,
Anne Durandy, and
Alain Fischer
From the Unité d'Immunologie et
d'Hématologie Pédiatriques, Service de
Réanimation Pédiatrique and INSERM U429,
Hôpital Necker Enfants-Malades; Service
d'Hématologie Clinique, Groupe hospitalier
Pitié-Salpétrière; Service de Pneumologie,
Hôtel-Dieu, Paris; Laboratoire de Virologie Medicale
Moléculaire, Faculté de Medecine de Grenoble, Domaine de la
Merci, La Tronche; Service de Pneumologie, Hôpital Foch, Suresnes
Cedex; Service de Néphrologie, Service d'Hématologie, CHU
de Poitiers, Poitiers; Service d'Hépatologie Pédiatrique,
Hôpital Bicêtre, Le Kremlin Bicêtre Cedex; Service
d'Hépatologie, Hôpital Henri Mondor, Créteil;
Service de Nephrologie et de transplantation rénale, CHU de Caen,
Besançon Cedex.
Severe T-cell immunodeficiency after solid organ or bone marrow
transplantation may result in the uncontrolled outgrowth of latently
Epstein-Barr virus-infected B cells, leading to B-lymphoproliferative disorder (BLPD). Given the potentially important pathogenic role of
IL-6 in BLPD, it was tested whether the in vivo neutralization of IL-6
by a monoclonal anti-IL-6 antibody could contribute to the control of
BLPD. Safety and efficacy were assessed in 12 recipients of
transplanted organs who had BLPD refractory to the reduction of
immunosuppression over 8 days. Five patients received 0.4 mg/kg per
day. The next 7 patients received 0.8 mg/kg per day. Treatment was
scheduled to last 15 days. It was completed in 10 patients, and in the
other 2 patients was discontinued early (days 10 and 13, respectively)
because of disease progression. Treatment tolerance was good, and no
major side effects were observed. High C-reactive protein levels were
found in 9 patients before treatment but were normalized under
treatment in all patients, demonstrating efficient IL-6 neutralization.
Complete remission (CR) was observed in 5 patients and partial
remission (PR) in 3 patients. Relapse was observed in 1 of these 8 patients in whom remission was observed. This relapse was unresponsive
to treatment. Disease was stable in 1 patient, but it progressed in 3 patients. Seven patients are alive and well. Two patients died because
of disease progression, and 3 patients died while in CR (chronic
rejection in 2 patients and BLPD sequelae in 1 patient). These data
suggest that the anti-IL-6 antibody is safe and should be further
explored in the treatment of BLPD.
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