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Cell Therapy News/Articles, page-11902

  1. Mabesato
    41 Posts.
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    21/10/21
    10:09
    Post #: 56959825
    Latest NEJM has a response from some medicos to a previous article on Ruxolitinib trial and its' efficacy. Point 5 below - interesting given the channels Meso has had to jump through.

    https://www.nejm.org/doi/full/10.1056/NEJMc2113499

    Ruxolitinib for Chronic Graft-versus-Host Disease

    TO THE EDITOR

    Zeiser et al. (July 15 issue) report a significantly better overall response in patients treated with ruxolitinib for glucocorticoid-refractory chronic graft-versus-host disease (GVHD), as they did 1 year ago for acute GVHD. The authors conclude that ruxolitinib was superior to control therapy, with no new safety signals. The data fail to convince. The authors describe chronic GVHD as “a leading cause…of nonrelapse-associated death.” However, overall survival did not differ substantially between the groups after half a year of treatment, with no fewer deaths from GVHD in the ruxolitinib group. Furthermore, the primary end point of overall response is based on criteria with primarily subjective components. The open-label design may have triggered a more optimistic observer evaluation. Scientific evaluation of the effectiveness of ruxolitinib should follow the same rigorous criteria as for any other drug. It is regrettable that the opportunity for a double-blind trial was missed. No treatment so far has improved survival for patients with glucocorticoid-refractory chronic GVHD; the case remains open.

    Alois Gratwohl, M.D.
    University of Basel, Basel, Switzerland

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    TO THE EDITOR

    Zeiser et al. conducted a randomized trial involving patients with glucocorticoid-refractory chronic GVHD that compared ruxolitinib with best available care. The authors observed improved overall response, failure-free survival, and symptom response in the ruxolitinib group. However, it should be noted that in Europe, inequalities exist in health according to socioeconomic status. After allogeneic hematopoietic stem-cell transplantation, patients with lower income and poorer access to health care and education had higher transplantation-related mortality (hazard ratio for death, 1.92; P=0.04) and worse survival (hazard ratio for death, 2.13; P=0.001). Furthermore, socioeconomic status is associated with the treatment outcome of chronic GVHD. Higher income (P=0.004), ability to work (P<0.001), and having a partner (P=0.02) were associated with better mean Lee chronic GVHD symptom scores. In addition, higher income (P=0.048), educational level (P=0.044), and ability to work (P<0.001) were significantly associated with better quality of life and improved activity, although the apparent significance for income and educational level would probably disappear if the data were corrected for multiple comparisons. We wonder whether there was an imbalance in socioeconomic status between the two groups in this trial.

    Motoharu Shibusawa, M.D.
    Shinmatsudo Central General Hospital, Chiba, Japan

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    RESPONSE

    The authors reply: Gratwohl observed that survival did not differ substantially between the trial groups at 6 months. Long-term survival will be reported when longer follow-up is available. However, we note that the trial was not powered to detect differences in overall survival and that the probability of survival may have been influenced by rescue therapies and crossover to ruxolitinib, which occurred in 61 patients at primary analysis and is likely to influence results from longer follow-up. Nevertheless, we do not believe that treatments must improve survival to be beneficial in this chronic disease. The open-label design that Gratwohl criticizes was unavoidable because no standard comparator is available. Instead, the control group received therapy for chronic GVHD according to investigator choice from 10 treatment options. Given the lack of standard practice in the field, the treatment that the patient would have received in clinical practice was considered the best comparator. Lastly, we note that the primary end point of this trial was overall response at week 24, which was checked for accuracy against National Institutes of Health response criteria. Key secondary end points were patient-reported symptoms and failure-free survival, which were improved in the ruxolitinib group. We agree that because this was not a blinded trial, clinician assessments, patient symptoms, and decisions about changing therapies may have been affected by the open-label design, but the consistency and magnitude of results from different perspectives, all in favor of ruxolitinib, give great confidence in the robustness of the results.

    Shibusawa summarizes South American and U.S. data about the association of socioeconomic status with survival and patient-reported symptoms of chronic GVHD. We did not collect information on income, ability to work, or having a partner to address whether these factors were associated with response, but randomization and adjustment for baseline symptom burden should have minimized substantial imbalances between the trial groups.

    Robert Zeiser, M.D.
    University of Freiburg, Freiburg, Germany

    Takanori Teshima, M.D., Ph.D.
    Hokkaido University, Sapporo, Japan

    Franco Locatelli, M.D., Ph.D.
    Ospedale Pediatrico Bambino Gesù, Rome, Italy


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