scholarly journals The Development of Extra-Articular Manifestations in Children With Enthesitis-Related Arthritis: Natural Course or Different Disease Entity?

2021 ◽  
Vol 8 ◽  
Author(s):  
Ilaria Pagnini ◽  
Mariangela Scavone ◽  
Ilaria Maccora ◽  
Maria Vincenza Mastrolia ◽  
Edoardo Marrani ◽  
...  
Keyword(s):  
Clinical Remission ◽  
Clinical Laboratory ◽  
Disease Onset ◽  
Biologic Agents ◽  
Imaging Data ◽  
Enthesitis Related Arthritis ◽  
Specific Category ◽  
Active Arthritis ◽  
Rheumatology Unit ◽  
Inflammatory Bowel

Introduction: Enthesitis-related Arthritis (ERA) is a specific category of juvenile idiopathic arthritis (JIA) characterized by axial and/or peripheral arthritis, and enthesitis, although other different extra-articular manifestations may encompass its clinical spectrum.Materials and Methods: In order to examine if ERA-JIA with extra-articular involvement may represent a different entity from ERA without extra-articular involvement, we performed a retrospective, observational, monocentric study, in a cohort of ERA patients followed between 2001 and September 2020 at the Pediatric Rheumatology Unit of Meyer Children Hospital of Florence. We analyzed the demographic, clinical, laboratory and imaging data at the disease onset, as well as after 3, 6, and 12 months follow up.Results: We have enrolled 53 patients, 33 males. At the time of diagnosis, average age was 10.9 years, 53 patients had active arthritis and 25 active enthesitis. The middle foot involvement was present in 20 patients. Twenty-five children achieved clinical remission on medication. Extra-articular manifestations were observed in 14 patients, of whom 3 had inflammatory bowel disease, 5 uveitis, one uveitis associated with Crohn disease, 4 SAPHO syndrome, one celiac disease. The cohort was stratified according to the presence/absence of extra-articular manifestations. It was observed that middle foot involvement was more frequent in patients with no extra-articular manifestations (18/39 vs. 2/14; χ2 = 4.45, p = 0.05). Additionally, patients presenting extra-articular manifestation needed more frequently (12/14 vs. 21/39, χ2= 4.45, p = 0.05), and preciously (months: 3.7 ± 5.4 vs. 16.7 ± 26.5, p = 0.02), treatment with biologic agents. Finally, these patients achieved belatedly (months: 31.6 ± 32.3 vs. 22.9 ± 18.3, p = 0.01) and less frequently (3/14 vs. 22/39; χ2= 5.50, p = 0.03) the clinical remission on medication. Eventually, extra-articular involvement inversely correlated with the middle-foot arthritis (ρs −0.29, p = 0.03), the chance to achieve remission on medication (ρs −0.31 e p = 0.02), as well as the chance to keep overall remission, with and without medication (ρs −0.28, p = 0.04).Conclusion: In our cohort, children diagnosed with ERA-JIA at the onset of disease and then developed extra-articular manifestations show the absence of middle foot involvement and worse prognosis with an early need for the use of biologic agents, and overall low chance to achieve remission.

scholarly journals AB0976 CAPTURING THE ENTHESITIS RELATED ARTHRITIS CONTEMPORARY PROFILE OF NORTHERN GREEK PATIENTS IN THE ERA OF BIOLOGICS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1782.1-1783
Author(s):  
D. Deligeorgakis ◽  
M. Trachana ◽  
P. Pratsidou-Gertsi ◽  
D. Dimopoulou ◽  
A. B. Haidich ◽  
...  
Keyword(s):  
Clinical Remission ◽  
Disease Onset ◽  
Young Patients ◽  
Disease Status ◽  
Median Percentage ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Enthesitis Related Arthritis ◽  
Negative Prognostic Factor

Background:Enthesitis-Related Arthritis (ERA) is a subtype of Juvenile Idiopathic Arthritis (JIA) subtype with an estimated prevalence ranging from 8% to 37.4%. The improvement of the disease course and outcome has been related with the introduction of biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) and the uninterrupted monitoring following the transition of young patients to adult rheumatology settings.Objectives:To capture the contemporary ERA profile in Northern Greek patients by analyzing the characteristics and treatment outcome in the era of bDMARDs.Methods:This retrospective cohort study included patients who had been monitored on a 3-month schedule for ≥12 months, from 2000 to 2017. The periodic metric assessment included the disease status and burden by applying contemporary tools in respect to activity, clinical remission (CR) and damage (cJADAS, JSpADA, Wallace criteria for CR and JADI, respectively).Results:Forty-three patients, mainly male (60%) with a mean age at disease onset of 10.75 (SD:2.75) years were enrolled. The predominant joints were the hip, ankle and sacroiliac (56%, 49% and 46%, respectively). Median lag time from diagnosis to bDMARDs initiation was 8.5 months. Patients with sacroiliitis were more likely to receive bDMARDs (hazard ratio [HR]:3.26, 95% confidence interval [CI]: 1.35, 7.88). Thirty six patients (84%) achieved clinical remission (CR) on medication (CRONM), within a median time of 11 months and correlated with compliance (HR:3.62, 95%CI: 1.34, 9.76). Twenty patients (47%) experienced a flare following CR, mainly as a single episode (75%). The median flare-free survival following remission on and off medication (CROFFM) was 42 and 34 months, respectively. At the last evaluation, both median baseline cJADAS (8), and JSpADA (2) dropped to 0, while 13 patients (30%) were in CROFFM, 17 (40%) in CRONM, and 13 (30%) had persistent disease activity. The median percentage of CR per patient was 54% and no patient had JADI >0.Conclusion:Early administration of bDMARDs and compliance to monitoring and treatment improved the long-term outcome in ERA. Axial involvement emerged as a negative prognostic factor with an increased need for bDMARDs and diminished rates of CR.Disclosure of Interests:Dimitrios Deligeorgakis: None declared, Maria Trachana: None declared, Polyxeni Pratsidou-Gertsi: None declared, Despoina Dimopoulou: None declared, Anna Bettina Haidich: None declared, Alexandros Garyfallos Grant/research support from: MSD, Aenorasis SA, Speakers bureau: MSD, Novartis, gsk

scholarly journals THE SAFETY, TOLERABILITY, AND EFFECTIVENESS OF BIOLOGICS/SMALL MOLECULE THERAPY IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE AND CIRRHOSIS

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S45-S46
Author(s):  
Muyi Li ◽  
Sameer Khan ◽  
Deborah Proctor ◽  
Jill Gaidos ◽  
Badr Al-Bawardy
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Small Molecules ◽  
Small Molecule ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Infusion Reaction ◽  
Mucosal Healing ◽  
Biologic Agents ◽  
Inflammatory Bowel

Abstract Introduction Biologic agents and small molecules have been shown to be effective and relatively safe in the treatment of inflammatory bowel disease (IBD). However, data is lacking regarding the use of these agents in patients with IBD and concomitant cirrhosis. The aim of this study is to examine the safety, tolerability and effectiveness of biologics and small molecules in patients with IBD and concomitant cirrhosis. Methods This is a retrospective study of adult patients diagnosed with both IBD and cirrhosis (by liver biopsy or Fibroscan) treated with biologic agents or small molecule agents between 2012 and 2020 within the Yale-New Haven Hospital system. We included patients on tofacitinib or any of the following biologic agents: infliximab, adalimumab, certolizumab pegol, golimumab, vedolizumab, ustekinumab. Primary outcomes were rates of adverse events (infection, infusion reaction, IBD-related hospitalization) and mortality. Secondary outcomes were clinical remission (defined by the physician global assessment) and mucosal healing (Mayo endoscopic score of 0 or 1 for ulcerative colitis (UC) and absence of erosion/ulcerations in Crohn’s disease (CD)). Results A total of 18 patients (72% CD, 28% UC) with median age of 50 (26–73) years were included (Table 1). Decompensated cirrhosis was present in 33.3% of the population prior to initiation of biologic/small molecule therapy. The most common etiology of cirrhosis was primary sclerosing cholangitis at 38.9%. IBD therapy included: infliximab/adalimumab (44.5%), vedolizumab (27.7%), and ustekinumab (22.2%) and tofacitinib (5.6%). A total of 4 patients (22.2%) were on concomitant corticosteroid therapy and 3 on combination therapy with thiopurines (Table 2). Adverse events occurred in 27.7% (n=5; 1 infusion reaction and 4 infections). The 4 patients with infections included: 2 on infliximab/adalimumab, 1 on ustekinumab, 1 on vedolizumab. Two of these patients were on concomitant thiopurines and 1 on corticosteroid. Biologic therapy was stopped in 3 patients, 2 for non-response and 1 for an infusion reaction. Mortality rate was 11% and all were liver-related. Clinical remission was achieved in 66.7% and mucosal healing was noted in 72.7% (8/11). Conclusions In this cohort of patients with IBD and cirrhosis, biologic/small molecule therapies were effective for IBD. Approximately a quarter of patients experienced adverse events that were mainly due to infections. Larger studies are needed to elucidate the relative safety of different biologic agents and small molecules in IBD patients with cirrhosis.

scholarly journals Fecal lactoferrin predicts primary non-response to biologic agents in inflammatory bowel disease

2021 ◽  
Author(s):  
Dario Sorrentino ◽  
Vu Q. Nguyen ◽  
Kim Love
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Biologic Agents ◽  
Fecal Lactoferrin ◽  
Inflammatory Bowel

Introduction: Fecal Lactoferrin (FL) is a timely and accurate marker of inflammation in ulcerative colitis (UC) and Crohn’s disease (CD). Aim of this study was to verify whether FL can predict primary non-response (PNR) to biologic agents during induction. Methods: Retrospective outcome review in 27 patients (13 with CD and 14 with UC) tested for baseline FL and re-tested within a week after the first and second induction doses. Clinical/biochemical outcomes were evaluated at end of induction and at follow up (3-24 months). Results: Compared to baseline, changes of the Harvey-Bradshaw (CD) and Partial Mayo Scoring (UC) indices at end of induction separated responders (18/27 or 67%) from non-responders (9/17 or 33%). In all patients the initial FL value at induction decreased compared to baseline, continuing to decrease after the following dose in clinical responders while bouncing back in the others. Models targeting the two consecutively decreased FL values or the second FL value compared to baseline or the second FL value compared to the first were able to accurately predict response at end of induction. Follow-up assessment confirmed clinical remission in initial responders (with FL values reduced on the average by 94±10% compared to baseline). Conclusions: In CD and UC patients during induction with biologic agents early FL measurements accurately separate clinical responders from those experiencing PNR. The method described here offers several potential advantages over other strategies to assess and manage these patients.

scholarly journals Relative Frequency and Risk Factors of COVID-19 Related Headache in a Sample of Egyptian Population: A Hospital-Based Study

Pain Medicine ◽  
2021 ◽  
Author(s):  
Mona Hussein ◽  
Wael Fathy ◽  
Ragaey A Eid ◽  
Hoda M Abdel-Hamid ◽  
Ahmed Yehia ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Platelet Count ◽  
Relative Frequency ◽  
Clinical Laboratory ◽  
Primary Headache ◽  
Female Gender ◽  
Imaging Data ◽  
Laboratory Findings ◽  
Neutrophil Lymphocyte Ratio ◽  
The Impact

Abstract Objectives Headache is considered one of the most frequent neurological manifestations of coronavirus disease 2019 (COVID-19). This work aimed to identify the relative frequency of COVID-19-related headache and to clarify the impact of clinical, laboratory findings of COVID-19 infection on headache occurrence and its response to analgesics. Design Cross-sectional study. Setting Recovered COVID-19 patients. Subjects In total, 782 patients with a confirmed diagnosis of COVID-19 infection. Methods Clinical, laboratory, and imaging data were obtained from the hospital medical records. Regarding patients who developed COVID-19 related headache, a trained neurologist performed an analysis of headache and its response to analgesics. Results The relative frequency of COVID-19 related headache among our sample was 55.1% with 95% confidence interval (CI) (.516–.586) for the estimated population prevalence. Female gender, malignancy, primary headache, fever, dehydration, lower levels of hemoglobin and platelets and higher levels of neutrophil/lymphocyte ratio (NLR) and CRP were significantly associated with COVID-19 related headache. Multivariate analysis revealed that female gender, fever, dehydration, primary headache, high NLR, and decreased platelet count were independent predictors of headache occurrence. By evaluating headache response to analgesics, old age, diabetes, hypertension, primary headache, severe COVID-19, steroid intake, higher CRP and ferritin and lower hemoglobin levels were associated with poor response to analgesics. Multivariate analysis revealed that primary headache, steroids intake, moderate and severe COVID-19 were independent predictors of non-response to analgesics. Discussion Headache occurs in 55.1% of patients with COVID-19. Female gender, fever, dehydration, primary headache, high NLR, and decreased platelet count are considered independent predictors of COVID-19 related headache.

scholarly journals Respiratory syncytial virus in severe lower respiratory infections in previously healthy young Ethiopian infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Abate Yeshidinber Weldetsadik ◽  
Frank Riedel
Keyword(s):  
Respiratory Syncytial Virus ◽  
Rainy Season ◽  
Clinical Laboratory ◽  
Respiratory Infections ◽  
Clinical Parameter ◽  
Imaging Data ◽  
Chi Square ◽  
Young Infants ◽  
Rsv Infection ◽  
Syncytial Virus

Abstract Background Respiratory Syncytial Virus (RSV) is the commonest cause of acute lower respiratory infections (ALRI) in infants. However, the burden of RSV is unknown in Ethiopia. We aimed to determine the prevalence, seasonality and predictors of RSV infection in young infants with ALRI for the first time in Ethiopia. Methods We performed RSV immuno-chromatographic assay from nasopharyngeal swabs of infants, 29 days to 6 months of age. We included the first 10 eligible infants in each month from June 2018 to May 2019 admitted in a tertiary pediatric center. Clinical, laboratory and imaging data were also collected, and chi-square test and regression were used to assess associated factors with RSV infection. Results Among a total of 117 study children, 65% were male and mean age was 3 months. Bronchiolitis was the commonest diagnosis (49%). RSV was isolated from 26 subjects (22.2%) of all ALRI, 37% of bronchiolitis and 11% of pneumonia patients. Although RSV infection occurred year round, highest rate extended from June to November. No clinical or laboratory parameter predicted RSV infection and only rainy season (Adjusted Odds Ratio (AOR) 10.46 [95%. C.I. 1.95, 56.18]) was independent predictor of RSV infection. Conclusions RSV was isolated in a fifth of young infants with severe ALRI, mostly in the rainy season. Diagnosis of RSV infection in our setting require specific tests as no clinical parameter predicted RSV infection. Since RSV caused less than a quarter of ALRI in our setting, the other causes should be looked for in future studies.

USTEKINUMAB FOR CHRONIC GRANULOMATOUS DISEASE-ASSOCIATED INFLAMMATORY BOWEL DISEASE

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S59-S59
Author(s):  
Sumona Bhattacharya ◽  
Beatriz Marciano ◽  
Harry Malech ◽  
Steven Holland ◽  
Suk See De Ravin ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Chronic Granulomatous Disease ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Colonic Disease ◽  
Cell Transplant ◽  
Granulomatous Disease ◽  
Efficacy And Safety ◽  
Serious Infections ◽  
Inflammatory Bowel

Abstract Introduction Chronic granulomatous disease (CGD) is a rare immunodeficiency caused by mutations in the NADPH oxidase complex. Dysregulated immune function may cause inflammatory bowel disease (IBD). Patients with CGD-associated IBD may not respond to or may develop serious infections as a result of traditional IBD therapies such as vedolizumab and infliximab. Ustekinumab is approved for use in Crohn’s disease and ulcerative colitis however there is scarce data on its efficacy and safety in CGD. Aims To evaluate the efficacy and safety of ustekinumab for CGD-associated IBD. Methods A retrospective chart review was conducted on CGD patients followed at a single center who had consented to participate in a natural history study. Clinical, laboratory, and endoscopic data were extracted in those that had received ustekinumab for IBD. Results Eight patients were found. Four were male and four were female. Five were white, one was Asian, one was black, and one was mixed race. Median age at diagnosis of CGD was 3 years (IQR 8) and of IBD was 15.5 years (IQR 20). Median age at initiation of ustekinumab was 27.5 years (IQR 14) and median duration on ustekinumab was 10 months (IQR 7). Six had colonic disease, two had ileocolonic disease, and six had perianal disease. Six failed other biologics (n=5 for vedolizumab, n=1 for infliximab, n=1 for adalimumab). Six patients symptomatically improved whereas two had no improvement. Changes in hemoglobin and C-reactive protein were equivocal. Three patients had improved endoscopic findings, two had unimproved findings, and three patients lacked this data. Overall, four patients achieved clinical remission. However, none of the five patients with endoscopic reevaluation achieved endoscopic remission. Three patients discontinued therapy due to lack of response: two required surgery and one underwent stem cell transplant. Fungal pneumonia (n=2), otitis media (n=1), oral herpes simplex virus 1 (n=1), and viral gastroenteritis (n=1) were reported. One infusion reaction occurred. Discussion In our cohort of eight patients with CGD-associated IBD receiving ustekinumab, results were mixed with four patients experiencing some degree of clinical or endoscopic improvement including four who achieved clinical remission. Multiple CGD-related variables may account for the mixed laboratory findings. Four of the five patients with endoscopic reevaluation had pre-existing strictures that would be unlikely to reverse with medical therapy alone. Of these, two had otherwise resolved endoscopic inflammation. Only two patients had no endoscopic improvement. Two serious infections occurred however CGD confers increased infectious susceptibility and no infections lead to discontinuation of therapy. Given these promising results, further formalized study of ustekinumab in CGD-associated IBD is needed.

scholarly journals Long-Term Follow-Up of Denosumab Discontinuers with Multiple Vertebral Fractures in the Real-World: A Case Series

2021 ◽  
Author(s):  
Liana Tripto-Shkolnik ◽  
Yair Liel ◽  
Naama Yekutiel ◽  
Inbal Goldshtein
Keyword(s):  
Real World ◽  
Vertebral Fractures ◽  
Clinical Laboratory ◽  
Case Series ◽  
High Risk Group ◽  
Imaging Data ◽  
Long Term Follow Up ◽  
Multiple Vertebral Fractures

AbstractDenosumab discontinuation is associated with rapid reversal of bone turnover suppression and with a considerable increase in fracture risk, including a risk for multiple vertebral fractures (MVF). Long-term follow-up of patients who sustained MVF after denosumab discontinuation has not been reported. This case-series was aimed to provide a long-term follow-up on the management and outcome of denosumab discontinuers who initially presented with multiple vertebral fractures. Denosumab discontinuers were identified from a computerized database of a large healthcare provider. Baseline and follow-up clinical, laboratory, and imaging data were obtained from the computerized database and electronic medical records. The post-denosumab discontinuers MVF patients consisted of 12 women aged 71±12. Osteoporotic fractures were prevalent before denosumab discontinuation in 6 of the patients. The majority received bisphosphonates before denosumab. MVF occurred 134±76 days after denosumab discontinuation. The patients were followed for a median of 36.5 (IQR 28.2, 42.5) months after MVF. Two patients passed-away. Two patients suffered recurrent vertebral fractures. Following MVF, patients were treated inconsistently with denosumab, teriparatide, oral, and intravenous bisphosphonates, in various sequences. Two patients underwent vertebroplasty/kyphoplasty. This long-term follow-up of real-world patients with MVF following denosumab discontinuation reveals that management is inconsistent, and recurrent fractures are not uncommon. It calls for clear management guidelines for patients with MVF after denosumab discontinuation and for special attention to this high-risk group.

scholarly journals AB0374 LUPUS LOW DISEASE ACTIVITY STATE AND MAINTAINING DRUG THERAPY: A RETROSPECTIVE INVESTIGATION

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1487.2-1487
Author(s):  
E. Gotelli ◽  
A. Sulli ◽  
G. Ferrari ◽  
G. Pacini ◽  
C. Schenone ◽  
...  
Keyword(s):  
Disease Activity ◽  
Hemolytic Anemia ◽  
Clinical Remission ◽  
Disease Onset ◽  
Treat To Target ◽  
Research Support ◽  
Low Disease Activity ◽  
Wide Range ◽  
Target Strategy ◽  
Activity State

Background:Systemic lupus erythematosus (SLE) is a chronic autoimmune multisystemic disease, that can begin with a wide range of clinical manifestations, and requires immunosuppressive therapies (1). A treat-to-target strategy leads to a high rate of clinical remission among patients (2). Several “remission” definitions have been provided in the last years and Lupus Low Disease Activity State (LLDAS) seems one of the best tools to evaluate it in clinical practice (3).Objectives:To evaluate the prevalence of SLE signs and symptoms at onset and the drugs used to induce and maintain the clinical remission, evaluated by LLDAS, in a real-life cohort of SLE patients.Methods:Thirty female SLE patients (mean age 52±15 years; mean age at disease onset 34±16 years, mean disease duration 18±13 years) in clinical remission have been enrolled (EULAR/ACR 2019 criteria) (4). Remission was defined by LLDAS (SLEDAI-2K < 4 and no activity in major organ systems, no hemolytic anemia; no new features of activity compared with previous assessment, physician global assessment (PGA) ≤ 1, prednisone dose ≤7.5 mg/day, well tolerated and stable therapy with maintenance doses of immunosuppressive drugs). Clinical and serological manifestations, SLEDAI-2K and pharmacological treatments were recorded at baseline and during follow-up.Results:Mucocutaneous involvement (57%), arthritis (30%), serositis (30%), nephritis (27%), leukopenia (23%), thrombocytopenia (20%), hemolytic anemia (13%), antiphospholipid syndrome manifestations (16%), neuro-psychiatric lupus symptoms (6%) were present in various combinations at disease onset. Baseline mean SLEDAI-2K was 10.5±2.5. Patients were treated with different dosages of glucocorticoids (100%), hydroxychloroquine (HCQ, 73%), cyclofosfamide (20%), mycophenolate mofetile (MMF, 13%), azathioprine (AZA, 13%), methotrexate (MTX, 13%), cyclosporine A (CSA, 6%), rituximab (3%), abatacept (ABA, 3%). Glucocorticoids were prescribed together with a single DMARD in 50% of cases and with two DMARDs in the remaining 50% of patients. Patients reached LLDAS remission after a mean time of 14±12 years, with a mean remission duration of 4.2±3.2 years (mean SLEDAI-2K at last visit 1±1; Mean PGA 0.4±0.1). Maintenance therapies during remission were prednisone ≤ 5 mg/day and/or HCQ ≤ 400 mg/day and/or CSA ≤ 200 mg/day and/or MTX ≤ 10 mg/weekly and/or MMF ≤ 2 g/day and/or AZA ≤ 100 mg/day. In particular, only prednisone 7%, only HCQ 3%, prednisone + HCQ 53%, prednisone + single DMARD (different from HCQ) 7%, prednisone + HCQ + DMARDs 30%.Conclusion:After reaching the clinical remission by a treat to target strategy, the administration of low dose of prednisone and HCQ in the majority of SLE patients (63%) seems useful to prevent new SLE flares. The retrospective design and the absence of a control group of patients with active disease limit this study.References:[1]Lisnevskaia L et al. 2014.Lancet384(9957):1878-1888.[2]Van Vollenhoven RF et al. 2014.Ann Rheum Dis73(6): 958-967.[3]Franklyn K et al. 2016.Ann Rheum Dis. 75(9): 1615-21.[4]Aringer M et al. 2019.Arthritis Rheumatol.71(9): 1400-1412.Disclosure of Interests:Emanuele Gotelli: None declared, Alberto Sulli Grant/research support from: Laboratori Baldacci, Giorgia Ferrari: None declared, Greta Pacini: None declared, Carlotta Schenone: None declared, Massimo Patanè: None declared, Pietro Francesco Bica: None declared, Carmen Pizzorni: None declared, Maurizio Cutolo Grant/research support from: Bristol-Myers Squibb, Actelion, Celgene, Consultant of: Bristol-Myers Squibb, Speakers bureau: Sigma-Alpha, Sabrina Paolino: None declared

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