Effect of up-front daclizumab when combined with steroids for the treatment of acute graft-versus-host disease: results of a randomized trial

Lee, Stephanie J.; Zahrieh, David; Agura, Edward; MacMillan, Margaret L.; Maziarz, Richard T.; McCarthy, Philip L.; Ho, Vincent T.; Cutler, Corey; Alyea, Edwin P.; Antin, Joseph H.; Soiffer, Robert J.

doi:10.1182/blood-2004-03-0854

Cited by 185 publications

(116 citation statements)

References 26 publications

Supporting

Mentioning

112

Contrasting

Unclassified

Order By: Relevance

“…In fact, the only randomized study showing disease-related reduced survival involved a population receiving Dac associated with steroids in the first-line treatment of GVHD. 15 Our relapse rate is in line with literature data, and involves three patients who received allogeneic HSCT for neuroblastoma, AML in second PR and ALL in second CR, respectively.…”

Section: Discussionsupporting

confidence: 87%

See 1 more Smart Citation

Daclizumab as useful treatment in refractory acute GVHD: a paediatric experience

Miano

Cuzzubbo

Terranova

et al. 2008

Bone Marrow Transplant

View full text Add to dashboard Cite

GVHD remains a serious complication after allogeneic SCT. We describe 13 paediatric patients treated with daclizumab for refractory acute GVHD (aGVHD). After 30 days of daclizumab administration, all patients with cutaneous aGVHD reached complete response. Among patients with gastrointestinal disease, 50 and 30% had complete and partial response, respectively, whereas 11 and 55% of patients with hepatic aGVHD achieved CR and PR, respectively. Overall, complete (46%) and partial (46%) responses were demonstrated in 92% of our patients, whereas the remaining patients (8%) were nonresponders. No life-threatening infectious episodes were recorded within 100 days from transplant in this selected group of paediatric patients. Overall 46% of patients were alive at a median of 461 days from SCT, but 50% of them developed chronic GVHD. In our experience, daclizumab proved to be a useful and safe treatment for refractory and steroid-resistant/dependent aGVHD, in particular for cutaneous and low-moderate intestinal involvement.

show abstract

Section: Discussionsupporting

confidence: 87%

“…15,16 Thirty days after treatment and 100 days after SCT, 46 and 45% of patients had CR to daclizumab, respectively, whereas 46 and 36% of patients obtained PR. These results confirm the higher response rate that was observed earlier in a paediatric series as compared with the series involving exclusively adult populations.…”

Section: Discussionmentioning

confidence: 99%

Daclizumab as useful treatment in refractory acute GVHD: a paediatric experience

Miano

Cuzzubbo

Terranova

et al. 2008

Bone Marrow Transplant

View full text Add to dashboard Cite

show abstract

“…Based on this encouraging data daclizumab was used in a trial for initial treatment for aGVHD along with steroids. The study was terminated early when the interim analysis showed worse survival for the combination arm at 100 days and 1 year [84]. This was thought to be a result of depletion of Tregs and their regulatory role in aGVHD.…”

Section: Anti-interleukin 2 Receptor Antibodiesmentioning

confidence: 99%

“…Based on these encouraging results, a randomized phase III trial of steroid and CI with MMF vs steroid and CI has started (BMT CTN Study 0802), but the study was terminated as preliminary results did not show any difference with addition of MMF [82]. Other agents such as basiliximab, daclizumab, antithymocyte globulin (ATG), etanercept and infliximab have also been tested without convincing results [83][84][85][86][87]. Based on these findings, the addition of agents to high-dose steroids in first-line treatment is only recommended in the setting of clinical trials.…”

Section: First-line Treatment Of Acute Gvhdmentioning

confidence: 99%

State-of-the-art acute and chronic GVHD treatment

Jamil

Mineishi

2015

Int J Hematol

View full text Add to dashboard Cite

owing to the advancement in reduced intensity conditioning (RIC) and in patients without HLA-matched donors due to the use of cord blood and haploidentical HSCT [4][5][6]. Although marked improvement has been made in supportive care, immunosuppressive therapy and DNA-based Human Leukocyte Antigen (HLA) typing, graft vs host disease (GVHD) remains a major cause of morbidity and non-relapse mortality among allogeneic HSCT recipients. It was first described by Billingham in 1966 as a syndrome where immunocompetent T cells from the donor recognize and damage the host tissue in an immunocompromised recipient. It presents with heterogeneous symptoms involving multiple organ systems including gastrointestinal tract, skin, mucosa, liver and lungs [7]. In the past clinical features occurring within 100 days after HSCT was called acute GVHD (aGVHD) and those happening after 100 days were labeled chronic GVHD (cGVHD) [8,9]. This definition was rather unsatisfactory thus National Institute of Health (NIH) consensus criteria were developed and have been revised. The criteria have added new categories such as late-onset aGVHD (acute GVHD occurring after 100 days) and overlap syndrome which includes features of both acute and chronic GVHD to the classification, and also have introduced new definitions for organ system involvement [10][11][12]. The categorization of acute vs chronic GVHD is based on the combination of clinical symptoms rather than the time of onset. Depending upon a number of variables associated with patients, donors, and types of transplant, the incidence of aGVHD varies with incidence of grade II-IV GVHD at 40 % in matched related donor (MRD) transplant to 50 % in MUD transplant. The main risk factors for aGVHD include degree of HLA mismatch, age of the patient, previous all immunization of the donor and the kind of GVHD prophylaxis used. About 30-70 % of allogeneic HSCT recipients alive after 100 days will Abstract Graft-versus-host disease (GVHD) remains as the major obstacle for successful hematopoietic stem cell transplant (HSCT). Roughly half of the patients undergoing HSCT develop GVHD which requires treatment, and above 10 % of the patient may die because of it. However, GVHD presents with anti-tumor activity, called graft-versus-tumor (GVT) effect, and it carries significant anti-tumor activity, thus suppressing GVHD completely may increase the relapse of original disease. Thus, it is important to control GVHD to the appropriate level.

show abstract

“…A retrospective study comparing a PSL-equivalent steroid dose of 1 and 2 mg/kg/day demonstrated no disadvantage of low-dose PSL at 1 mg/kg/day for patients with mild grade II acute GVHD [114]. Comparative studies evaluating a combination of PSL and other immunosuppressants, including antibodies against interleukin-2, ATG, etanercept, and infliximab [115][116][117][118][119][120], did not demonstrate an advantage of the addition of these immunosuppressants to PSL. Oral beclomethasone dipropionate (BDP) allowed PSL to be rapidly tapered, with fewer recurrences of gastrointestinal GVHD [121].…”

Section: Initial Therapy Of Acute Gvhdmentioning

confidence: 99%

Prophylactic and therapeutic treatment of graft-versus-host disease in Japan

Murata

2015

Int J Hematol

View full text Add to dashboard Cite

Effect of up-front daclizumab when combined with steroids for the treatment of acute graft-versus-host disease: results of a randomized trial

Cited by 185 publications

References 26 publications

Daclizumab as useful treatment in refractory acute GVHD: a paediatric experience

Daclizumab as useful treatment in refractory acute GVHD: a paediatric experience

State-of-the-art acute and chronic GVHD treatment

Prophylactic and therapeutic treatment of graft-versus-host disease in Japan

Contact Info

Product

Resources

About