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Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia

Sif Gudbrandsdottir, Henrik Sverre Birgens, Henrik Frederiksen, Bjarne Anker Jensen, Morten Krogh Jensen, Lars Kjeldsen, Tobias Wirenfeldt Klausen, Herdis Larsen, Hans Torben Mourits-Andersen, Claus Henrik Nielsen, Ove Juul Nielsen, Torben Plesner, Stanislaw Pulczynski, Inge Helleberg Rasmussen, Dorthe Rønnov-Jessen and Hans Carl Hasselbalch

Data supplements

Article Figures & Data

Figures

  • Figure 1

    Patient flowchart. AML, acute myeloid leukemia; CLL, chronic lymphatic lymphoma; MDS, myelodysplastic syndrome.

  • Figure 2

    Kaplan-Meier plot of time to relapse in patients achieving initial, partial, or complete response. Relapse was defined as a drop in platelet count to ≤50 × 109/L following a complete response (platelet count ≥100 × 109/L), partial response (platelet count ≥50 × 109/L), or initial response (increase in platelet counts of at least 30 × 109/L, platelet counts >50 × 109/L on day 10 and no clinical bleeding). No. at risk indicates number of patients with sustained complete or partial response. P = .03.

  • Figure 3

    Adverse events. Adverse events reported by >5% of patients in either the rituximab + dexamethasone group or dexamethasone group. *P < .05.

Tables

  • Table 1

    Baseline characteristics

    ParameterRTX+DXM (n = 62)DXM (n = 71)P value for difference between groups
    Age, median (IQR)51 y (36-63)58 y (41-70).2
    Females, n (%)36 (58%)34 (48%).3
    Baseline platelet count ×109/L, median (IQR)13 (6-20)14 (8-23).4
    Follow-up period in days, median (IQR)921 (526-1152)922 (190-1126).3
    Dexamethasone cycles during treatment
     1 cycle, no. of patients (%)43 (69%)40 (56%).09
     2-3 cycles, no. of patients (%)16 (26%)22 (31%)
     >4 cycles, no. of patients (%)3 (5%)9 (13%)
    • IQR, interquartile range.

  • Table 2

    Serious adverse events and infections

    ParameterRTX+DXMDXM
    Total serious adverse events169
    Thrombocytopenia (without bleeding) requiring hospitalization50
     Bleeding grade 3-421
     Deaths1*3
     Fever21
     Pain11
     Dizziness11
     Infusion-related anaphylaxis10
     Delayed neutropenia10
     Vasculitis10
     Cataract10
     Hyperglycemia01
     Chest pain01
    Total reported infections119
     Upper respiratory tract41
     Topical41§
     Oral candida03
     Pneumonia22
     Urinary tract12
     Herpes genitalis11
    • * 84-y-old female deceased from pneumonia and heart failure 33 mo after inclusion.

    • 83-y-old female deceased from atrial fibrillation and sepsis 3 wk after inclusion; 80-y-old male deceased in own home 4 d after inclusion, cause unknown; 80-y-old woman deceased 33 mo after inclusion, cause unknown.

    • Bursitis, otitis, bartholinitis, and eye infection.

    • § Furunculi.

    • In both groups, age at the time of inclusion was in the range of 18 to 84 years.