A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia

Henrik Birgens; Henrik Frederiksen; Hans C Hasselbalch; Inge Helleberg Rasmussen; Ove J Nielsen; Lars Kjeldsen; Herdis Larsen; Torben Mourits-Andersen; Torben Plesner; Dorthe Rønnov-Jessen; Hanne Vestergaard; Tobias W Klausen; Claudia Schöllkopf

doi:10.1111/bjh.12541

A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia

Henrik Birgens, Henrik Frederiksen, Hans C Hasselbalch, Inge Helleberg Rasmussen, Ove J Nielsen, Lars Kjeldsen, Herdis Larsen, Torben Mourits-Andersen, Torben Plesner, Dorthe Rønnov-Jessen, Hanne Vestergaard, Tobias W Klausen, Claudia Schöllkopf

74 Citationer (Scopus)

Abstract

The impact of first-line treatment with the anti-CD 20 chimeric monoclonal antibody rituximab in patients with warm-antibody reactive autoimmune haemolytic anaemia (WAIHA) is unknown. We report the first randomized study of 64 patients with newly diagnosed WAIHA who received prednisolone and rituximab combined (N = 32) or prednisolone monotherapy (N = 32). After 12 months, a satisfactory response was observed in 75% of the patients treated with rituximab and prednisolone but in a significantly smaller proportion (36%) of those given prednisolone alone (P = 0·003). Furthermore, relapse-free survival was significantly better after the combined therapy than after prednisolone monotherapy (P = 0·02). After 36 months, about 70% of the patients were still in remission in the rituximab-prednisolone group, whereas only about 45% were still in complete or partial remission in the prednisolone group. There was no significant difference between the two groups regarding adverse reactions to the studied medications. Likewise, serious adverse events were equally distributed, and no allergic reactions to rituximab were recorded. In conclusion, our data show that using rituximab and prednisolone combined rather than prednisolone alone as first-line treatment in WAIHA increases both the rate and the duration of the response.

Originalsprog	Engelsk
Tidsskrift	British Journal of Haematology
Vol/bind	163
Udgave nummer	3
Sider (fra-til)	393–399
Antal sider	7
ISSN	0007-1048
DOI	https://doi.org/10.1111/bjh.12541
Status	Udgivet - nov. 2013

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10.1111/bjh.12541

https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/bjh.12541

Citationsformater

Birgens, H., Frederiksen, H., Hasselbalch, H. C., Rasmussen, I. H., Nielsen, O. J., Kjeldsen, L., Larsen, H., Mourits-Andersen, T., Plesner, T., Rønnov-Jessen, D., Vestergaard, H., Klausen, T. W., & Schöllkopf, C. (2013). A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia. British Journal of Haematology, 163(3), 393–399. https://doi.org/10.1111/bjh.12541

A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia. / Birgens, Henrik; Frederiksen, Henrik; Hasselbalch, Hans C et al.

I: British Journal of Haematology, Bind 163, Nr. 3, 11.2013, s. 393–399.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Birgens, H, Frederiksen, H, Hasselbalch, HC, Rasmussen, IH, Nielsen, OJ, Kjeldsen, L, Larsen, H, Mourits-Andersen, T, Plesner, T, Rønnov-Jessen, D, Vestergaard, H, Klausen, TW & Schöllkopf, C 2013, 'A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia', British Journal of Haematology, bind 163, nr. 3, s. 393–399. https://doi.org/10.1111/bjh.12541

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title = "A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia",

abstract = "The impact of first-line treatment with the anti-CD 20 chimeric monoclonal antibody rituximab in patients with warm-antibody reactive autoimmune haemolytic anaemia (WAIHA) is unknown. We report the first randomized study of 64 patients with newly diagnosed WAIHA who received prednisolone and rituximab combined (N = 32) or prednisolone monotherapy (N = 32). After 12 months, a satisfactory response was observed in 75% of the patients treated with rituximab and prednisolone but in a significantly smaller proportion (36%) of those given prednisolone alone (P = 0·003). Furthermore, relapse-free survival was significantly better after the combined therapy than after prednisolone monotherapy (P = 0·02). After 36 months, about 70% of the patients were still in remission in the rituximab-prednisolone group, whereas only about 45% were still in complete or partial remission in the prednisolone group. There was no significant difference between the two groups regarding adverse reactions to the studied medications. Likewise, serious adverse events were equally distributed, and no allergic reactions to rituximab were recorded. In conclusion, our data show that using rituximab and prednisolone combined rather than prednisolone alone as first-line treatment in WAIHA increases both the rate and the duration of the response.",

author = "Henrik Birgens and Henrik Frederiksen and Hasselbalch, {Hans C} and Rasmussen, {Inge Helleberg} and Nielsen, {Ove J} and Lars Kjeldsen and Herdis Larsen and Torben Mourits-Andersen and Torben Plesner and Dorthe R{\o}nnov-Jessen and Hanne Vestergaard and Klausen, {Tobias W} and Claudia Sch{\"o}llkopf",

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pages = "393–399",

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AU - Birgens, Henrik

AU - Frederiksen, Henrik

AU - Hasselbalch, Hans C

AU - Rasmussen, Inge Helleberg

AU - Nielsen, Ove J

AU - Kjeldsen, Lars

AU - Larsen, Herdis

AU - Mourits-Andersen, Torben

AU - Plesner, Torben

AU - Rønnov-Jessen, Dorthe

AU - Vestergaard, Hanne

AU - Klausen, Tobias W

AU - Schöllkopf, Claudia

PY - 2013/11

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N2 - The impact of first-line treatment with the anti-CD 20 chimeric monoclonal antibody rituximab in patients with warm-antibody reactive autoimmune haemolytic anaemia (WAIHA) is unknown. We report the first randomized study of 64 patients with newly diagnosed WAIHA who received prednisolone and rituximab combined (N = 32) or prednisolone monotherapy (N = 32). After 12 months, a satisfactory response was observed in 75% of the patients treated with rituximab and prednisolone but in a significantly smaller proportion (36%) of those given prednisolone alone (P = 0·003). Furthermore, relapse-free survival was significantly better after the combined therapy than after prednisolone monotherapy (P = 0·02). After 36 months, about 70% of the patients were still in remission in the rituximab-prednisolone group, whereas only about 45% were still in complete or partial remission in the prednisolone group. There was no significant difference between the two groups regarding adverse reactions to the studied medications. Likewise, serious adverse events were equally distributed, and no allergic reactions to rituximab were recorded. In conclusion, our data show that using rituximab and prednisolone combined rather than prednisolone alone as first-line treatment in WAIHA increases both the rate and the duration of the response.

AB - The impact of first-line treatment with the anti-CD 20 chimeric monoclonal antibody rituximab in patients with warm-antibody reactive autoimmune haemolytic anaemia (WAIHA) is unknown. We report the first randomized study of 64 patients with newly diagnosed WAIHA who received prednisolone and rituximab combined (N = 32) or prednisolone monotherapy (N = 32). After 12 months, a satisfactory response was observed in 75% of the patients treated with rituximab and prednisolone but in a significantly smaller proportion (36%) of those given prednisolone alone (P = 0·003). Furthermore, relapse-free survival was significantly better after the combined therapy than after prednisolone monotherapy (P = 0·02). After 36 months, about 70% of the patients were still in remission in the rituximab-prednisolone group, whereas only about 45% were still in complete or partial remission in the prednisolone group. There was no significant difference between the two groups regarding adverse reactions to the studied medications. Likewise, serious adverse events were equally distributed, and no allergic reactions to rituximab were recorded. In conclusion, our data show that using rituximab and prednisolone combined rather than prednisolone alone as first-line treatment in WAIHA increases both the rate and the duration of the response.

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DO - 10.1111/bjh.12541

M3 - Journal article

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SN - 0963-1860

VL - 163

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JO - British Journal of Haematology, Supplement

JF - British Journal of Haematology, Supplement

IS - 3

ER -

A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia

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