Consensus recommendations for improvement of unmet clinical needs—the example of chronic graft-versus-host disease: a systematic review and meta-analysis

Olivieri, Jacopo; Manfredi, Lucia; Postacchini, Laura; Tedesco, Silvia; Leoni, Pietro; Gabrielli, Armando; Bacigalupo, Andrea; Olivieri, Attilio; Pomponio, Giovanni

doi:10.1016/s2352-3026(15)00095-2

Cited by 18 publications

(10 citation statements)

References 27 publications

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“…In 2005, the NIH cGVHD Consensus panel developed response criteria to improve evaluation of cGVHD response 27 ; implementation of these criteria has been shown to reduce bias in the reported efficacy of second-line treatment of cGVHD. 31 Although the NIH criteria were created to provide the most objective assessments of response, they still represent a subjective determination of cGVHD activity by the clinician. Because the present study used the NIHdefined response criteria, the ORR in this study is more robust than those reported in historical studies.…”

Section: Discussionmentioning

confidence: 99%

Ibrutinib for chronic graft-versus-host disease after failure of prior therapy

Miklos

Cutler

Arora

et al. 2017

Blood

375

253

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• Ibrutinib induced a high rate of sustained responses for patients with cGVHD and inadequate response to corticosteroid-containing therapy.• This trial supported the approval of ibrutinib for treatment of adult patients with cGVHD after failure of $1 lines of systemic therapy.Chronic graft-versus-host disease (cGVHD) is a serious complication of allogeneic stem cell transplantation with few effective options available after failure of corticosteroids. B and T cells play a role in the pathophysiology of cGVHD. Ibrutinib inhibits Bruton tyrosine kinase in B cells and interleukin-2-inducible T-cell kinase in T cells. In preclinical models, ibrutinib reduced severity of cGVHD. This multicenter, open-label study evaluated the safety and efficacy of ibrutinib in patients with active cGVHD with inadequate response to corticosteroid-containing therapies. Forty-two patients who had failed 1 to 3 prior treatments received ibrutinib (420 mg) daily until cGVHD progression. The primary efficacy end point was cGVHD response based on 2005 National Institutes of Health criteria. At a median follow-up of 13.9 months, best overall response was 67%; 71% of responders showed a sustained response for ‡20 weeks. Responses were observed across involved organs evaluated. Most patients with multiple cGVHD organ involvement had a multiorgan response. Median corticosteroid dose in responders decreased from 0.29 mg/kg per day at baseline to 0.12 mg/kg per day at week 49; 5 responders discontinued corticosteroids. The most common adverse events were fatigue, diarrhea, muscle spasms, nausea, and bruising. Plasma levels of soluble factors associated with inflammation, fibrosis, and cGVHD significantly decreased over time with ibrutinib. Ibrutinib resulted in clinically meaningful responses with acceptable safety in patients with ‡1 prior treatments for cGVHD. Based on these results, ibrutinib was approved in the United States for treatment of adult patients with cGVHD after failure of 1 or more lines of systemic therapy. This trial was registered at www.clinicaltrials.gov as #NCT02195869. (Blood. 2017;130(21):2243-2250

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Section: Discussionmentioning

confidence: 99%

Ibrutinib for chronic graft-versus-host disease after failure of prior therapy

Miklos

Cutler

Arora

et al. 2017

Blood

375

253

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“…10,15 Reports from the retrospective and prospective studies on this field indicated high response rates, but results remain difficult to interpret because of deficiencies in study design. 6,10 As consequence, in a recent consensus conference, steroids only achieved a strength of evidence level BIII-I, whereas all other options were graded less. 15 According to the cGvHD survey, ECP and MMF were the most widely used treatments, other than rechallenge with steroids and calcineurine inhibitors, and this is in line with most of the published indications.…”

Section: Discussionmentioning

confidence: 99%

“…Although the National Institute of Health (NIH) consortium have made a considerable effort for sharing standardized guidelines published in 2005, 5 and more recently further updated, 2 a recent meta-analysis showed little progress in this field. 6 On behalf of the Gruppo Italiano Trapianto di Midollo Osseo (GITMO), two questionnaires were proposed to Italian Centers performing allogeneic HCT, intended to address the 'real-life' management of cGvHD. Although heterogeneity of physician practice in allogeneic HCT has been demonstrated by many studies, [7][8][9] these surveys were focused on the practice of the centers (not single physician) and potential difficulties in following guidelines, with the aim to better design feasible prospective trials.…”

Section: Introductionmentioning

confidence: 99%

‘Real-life’ report on the management of chronic GvHD in the Gruppo Italiano Trapianto Midollo Osseo (GITMO)

Giaccone¹,

Mancini

Mordini

et al. 2017

Bone Marrow Transplant

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Several guidelines have been published about management of chronic GvHD (cGvHD), but the clinical practice still remains demanding. The Gruppo Italiano Trapianto di Midollo Osseo (GITMO) has planned a prospective observational study on cGvHD, supported by a dedicated software, including the updated recommendations. In view of this study, two surveys have been conducted, focusing the management of cGvHD and ancillary therapy in cGvHD, to address the current 'real life' situation. The two surveys were sent to all 57 GITMO centers, performing allografting in Italy; the response rate was 57% and 66% of the interviewed centers, respectively. The first survey showed a great disparity especially regarding steroid-refractory cGvHD, although extracorporeal photo-apheresis resulted as the most indicated treatment in this setting. Another challenging issue was the strategy for tapering steroid: our survey showed a great variance, and this disagreement could be a real bias in evaluating outcomes in prospective studies. As for the second survey, the results suggest that the ancillary treatments are not standardized in many centers. All responding centers reported a strong need to standardize management of cGvHD and to participate in prospective trials. Before starting observational and/or interventional studies, a detailed knowledge of current practice should be encouraged.

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“…Active implementation of recommendations developed by our study will be an outstanding challenge for the next future. Previous experiences 69 showed, indeed, negligible improvements in practice after the publication of expert-based recommendations, even when coming from authoritative institutions (e.g., NIH). Adequately funded strategies such as clinical audits are strongly needed to promote a meaningful improvement in real-world practice and to verify the impact on clinical and organizational outcomes.…”

Section: Future Directionsmentioning

confidence: 95%

Heel Pressure Injuries: Consensus-Based Recommendations for Assessment and Management

Rivolo¹,

Dionisi²,

Olivari

et al. 2020

Advances in Wound Care

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Significance: A systematic approach to develop experts-based recommendations could have a favorable impact on clinical problems characterized by scarce and low-quality evidence as heel pressure ulcers. Recent Advances: A systematic approach was used to conduce a formal consensus initiative. A multidisciplinary panel of experts identified relevant clinical questions, performed a systematic search of the literature, and created a list of statements. GRADE Working Group guidelines were followed. An independent international jury reviewed and voted recommendations for clinical practice. Consent was developed according to Delphi rules and GRADE method was used to attribute grade of strength. Critical Issues: The extensive search of the literature retrieved 42 pertinent articles (26 clinical studies, 7 systematic reviews or meta-analysis, 5 other reviews, 2 consensus-based articles, and 2 in vitro studies). Thirty-five recommendations and statements were created. Only 1 of 35, concerning ankle-brachial pressure index reliability in diabetic patients, was rejected by the panel. No sufficient agreement was achieved on toe brachial index test to rule out the orphan heel syndrome, removing dry eschar in adult patients without vascular impairment, and using an antimicrobial dressing in children with infected heel pressure injuries. Eleven recommendations were approved with a weak grade of strength. Experts strongly endorsed 20 recommendations. Offloading, stages I and II pressure injuries, and referral criteria were areas characterized by higher level of agreement. Future Directions: We believe that the results of our effort could improve practice, especially in areas where clear and shared opinions emerged. Barriers and limits that could hinder implementation are also discussed in the article.

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Consensus recommendations for improvement of unmet clinical needs—the example of chronic graft-versus-host disease: a systematic review and meta-analysis

Cited by 18 publications

References 27 publications

Ibrutinib for chronic graft-versus-host disease after failure of prior therapy

Ibrutinib for chronic graft-versus-host disease after failure of prior therapy

‘Real-life’ report on the management of chronic GvHD in the Gruppo Italiano Trapianto Midollo Osseo (GITMO)

Heel Pressure Injuries: Consensus-Based Recommendations for Assessment and Management

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