Ibrutinib in combination with rituximab is highly effective in treatment of steroid refractory autoimmune hemolytic anemia

Author:

Nikitin Eugene1,Kislova Maria2ORCID,Morozov Dmitry3,Belyakova Vera4,Suvorova Anna3,Sveshnikova Julia5,Vyscub Galina6,Matveeva Irina2,Shirokova Maria2,Shipaeva Anna6,Klitochenko Tatyana6,Dmitrieva Elena7ORCID,Biderman Bella8,Sudarikov Andrey8,Obukhova Tatyana8,Samoilova Olga3,Kaplanov Kamil2,Konstantinova Tatyana5,Mayorova Olga2,Poddubnaya Irina9,Ptushkin Vadim7ORCID

Affiliation:

1. S. P. Botkin's city hospital

2. State Budgetary Healthcare Institution of the city of Moscow City Clinical Hospital named after S.P. Botkin of Moscow City Healthcare Department

3. State Budgetary Health Institution of the Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko"

4. State Budgetary Healthcare Institution of the city of Moscow Blood Center named after O.K. Gavrilov of the Moscow City Healthcare Department

5. State Autonomous Healthcare Institution of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital N 1"

6. State Budgetary Health Institution "Volgograd Regional Clinical Oncology Center"

7. City Clinical Hospital named after S.P. Botkin

8. National Medical Research Center for Hematology

9. Federal State Budgetary Educational Institution of Further Professional Education “Russian Medical Academy of Continuous Professional Education” of the Ministry of Healthcare of the Ru

Abstract

Abstract Autoimmune hemolytic anemia (AIHA) and pure red cell aplasia (PRCA) are common complications of CLL. The optimal treatment of steroid refractory AIHA/PRCA is not well established. We conducted a multicenter study of ibrutinib and rituximab in patients with relapsed/refractory to steroids AIHA/PRCA and underlying CLL. Protocol included induction (ibrutinib 420 mg/day and rituximab, 9 weekly and 3 monthly infusions) and maintenance phase with ibrutinib until progression or unacceptable toxicity. Fifty patients were recruited (44 – warm type AIHA, 2 – cold type AIHA, 4 – PRCA). After the induction phase 34 patients (74%) have achieved complete response, and 10 (21,7%) partial response. Median time to hemoglobin normalization was 85 days. With regards to CLL response 9 (19%) patients have achieved CR, 2 (4%) patients – stabilization and 39 (78%) – PR. The median follow-up was 37.56 months. In AIHA group 2 patients had a relapse. Among 4 patients with PRCA 1 patient did not respond, and 1 patient had a relapse after CR, 2 remained in CR. The most common adverse events were neutropenia (62%), infections (72%) and gastrointestinal complications (54%). In conclusion ibrutinib in combination with rituximab is an active second-line treatment option for patients with relapsed or refractory AIHA/PRCA and underlying CLL.

Publisher

Research Square Platform LLC

Reference46 articles.

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