Patient-reported outcomes for determining prognostic groups in veterans with stage IV solid tumors starting systemic therapy.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9567-9567
Author(s):  
Victor T Chang ◽  
Charles B. Scott ◽  
Jan Einhorn ◽  
Houling Yan ◽  
Melanie L. Gonzalez ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Median Survival ◽  
Systemic Therapy ◽  
Stage Iv ◽  
Group 4 ◽  
Patient Reported ◽  
Prognostic Groups ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

9567 Background: A Recursive Partitioning Analysis (RPA) algorithm predicted four groups with distinct median survivals in patients with advanced cancer entering palliative care (ASCO 2010, Abst 9040). We investigated whether this algorithm could apply to cancer patients starting systemic therapy. Methods: The RPA algorithm is based upon Karnofsky performance status (KPS), Functional Assessment of Cancer Therapy (FACT) physical well-being (PWB) subscale, and Memorial Symptom Assessment Scale Short Form (MSAS-SF) physical symptom distress (PHYS) subscale. Starting in 2007, a convenience sample of Veterans who were prescribed systemic treatment for their cancer was enrolled in an IRB approved protocol, and completed quality of life (FACT- G) and symptom (MSAS SF) questionnaires prior to starting the first cycle of treatment. We analyzed records of patients with stage IV metastatic solid tumors enrolled through August 2011, and determined survival as of December 1, 2012. Analyses were performed with STATA 11.0. Results: There were 72 patients (pts). The median age was 63 yrs, (range 46-86). Men comprised 71 (98%) pts. First line systemic therapy was given to 59 (82%) pts. The most common primary sites were lung cancer (25 pts, 35%), prostate 9 pts(12%) and colon 7 pts (10%). Median KPS was 90% (range 40-100%), PWB median 23 (range 6-28), and MSAS SF median PHYS 0.73 (range 0-2.93). Overall median survival was 269 days (range 6-1762) and 57 pts (79%) had died. There was 1 pt in group 1, 45 pts in group 2, 8 pts in group 3, and 18 pts in group 4. Median survival (days) by RPA group was 155 for group 1, 177 for group 2, 292 for group 3, and 610 for group 4 (p=.011). Conclusions: These preliminary findings suggest that this algorithm is capable of dividing patients with metastatic solid tumor who are starting chemotherapy into prognostic groups. It may have applications in clinical trials. Further development is indicated. [Table: see text]

Patient-reported outcomes for determining prognostic groups in veterans with stage IV solid tumors starting systemic therapy.

2014 ◽  
Vol 32 (31_suppl) ◽  
pp. 48-48
Author(s):  
Victor Tsu-Shih Chang ◽  
Charles B. Scott ◽  
Melanie L. Gonzalez ◽  
Jan Einhorn ◽  
Houling Yan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Solid Tumors ◽  
Systemic Therapy ◽  
Stage Iv ◽  
Group 4 ◽  
Prognostic Groups ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

48 Background: A Recursive Partitioning Analysis (RPA) prognostic algorithm based on quality of life and symptoms predicted 4 groups with distinct median survivals in patients with metastatic solid tumors receiving chemotherapy (ASCO 2013, Abst 9567). We update our findings. Methods: The RPA algorithm is based upon Karnofsky performance status (KPS), Functional Assessment of Cancer Therapy (FACT) physical well-being (PWB) subscale, and Memorial Symptom Assessment Scale Short Form (MSAS-SF) physical symptom distress (PHYS) subscale. Starting in 2007, a convenience sample of Veterans who were prescribed systemic treatment for their cancer was enrolled in an IRB approved protocol, and completed quality of life (FACT- G) and symptom (MSAS SF) questionnaires at the first cycle of treatment. We analyzed records of patients with stage IV metastatic solid tumors enrolled through June 2013, and determined survival as of June 15, 2014. Analyses were performed with STATA 11.0. Results: There were 97 patients(pts). The median age was 64 yrs, range 27-88. Males comprised 95 (98%) pts. First line chemotherapy was given to 78 (80%) pts. The most common primary sites were lung cancer 33 (35%), prostate 17 (17%) and colon 11 (11%) pts. Median KPS was 90% range 40-100%, PWB median 23 (range 6-28), and MSAS SF median PHYS 0.76 (range 0-3.2). Overall median survival was 285 days (range 6-2,358) and 80 pts (82%) had died. There was 1 pt in group 1, 58 in group 2, 12 in group 3, and 23 in group 4. The patient in group 1 had uterine sarcoma. Median survival (days) by RPA group was 155 for group 1, 177 for group 2, 292 for group 3, and 674 for group 4 (p=.011). Conclusions: These preliminary findings suggest that this algorithm is capable of dividing patients with metastatic solid tumor who are starting systemic therapy into prognostic groups. Further development is indicated.

Optimising prediction of early metastasis-free survival in uveal melanoma using a four-category model incorporating gene expression profile and tumour size

2021 ◽  
pp. bjophthalmol-2020-317714
Author(s):  
Kelsey Andrea Roelofs ◽  
Parampal Grewal ◽  
Steven Lapere ◽  
Matthew Larocque ◽  
Albert Murtha ◽  
...  
Keyword(s):  
Gene Expression ◽  
Gene Expression Profile ◽  
Information Criteria ◽  
Free Survival ◽  
Group 4 ◽  
Prognostic Groups ◽  
Class 1 ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

BackgroundLargest basal diameter (LBD) appears to have independent prognostic value in uveal melanoma (UM).MethodsAll patients undergoing plaque brachytherapy or enucleation for UM involving the choroid and/or ciliary body between 2012 and 2019.ResultsA total of 348 patients with a mean age of 60±14 years were included and followed for a mean of 40±26 months (3.3±2.2 years). On multivariate analysis, LBD >12 mm remained a significant independent predictor of metastasis for both class 1 (HR 21.90; 95% CI 2.69 to 178.02; p=0.004) and class 2 (HR 2.45; 95% CI, 1.03 to 5.83; p=0.04) tumours. Four prognostic groups were created: group 1 (class 1, LBD <12 mm), group 2 (class 1, LBD ≥12 mm), group 3 (class 2, LBD <12 mm) and group 4 (class 2, LBD ≥12 mm). Life tables were used to calculate the 3-year and 5-year metastasis-free survival: group 1 (98 and 98%), group 2 (86 and 86%), group 3 (81 and 62%) and group 4 (54 and 47%). Compared with the reference category (group 1), the Cox proportional hazard model demonstrated a significant worsening of survival for each progressive category (group 2 (HR 21.59; p=0.004), group 3 (HR 47.12, p<0.001), and group 4 (HR 114.24; p<0.001)). In our dataset, the four-category Cox model performed poorer compared with the American Joint Committee on Cancer (AJCC) and gene expression profile (AJCC+GEP) in the Akaike’s information criteria (AIC) (297 vs 291), fit better with the Bayesian information criteria (BIC) (309 vs 313) and performed similarly with the Harrel’s C (0.86 (95% CI 0.80 to 0.91) vs 0.89 (0.84 to 0.94), respectively).ConclusionsCombination of GEP and LBD allows separation of patients into four easy-to-use prognostic groups and was similar to a model combining AJCC stage with GEP.

Management of Acute Myeloid Leukemia (AML) in First Relapse: Retrospective Analysis about 101 Adults Cases Receiving Homogeneous First-Line Therapy. Impact of Prognostic Factors and Treatment.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 882-882
Author(s):  
Cecile Fohrer ◽  
Brigitte Witz ◽  
Jean Luc Harousseau ◽  
Francis Witz ◽  
Shanti Ame ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Median Survival ◽  
Complete Response ◽  
Intensive Chemotherapy ◽  
Group 4 ◽  
Line Therapy ◽  
First Relapse ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract We retrospectively analyzed impact of prognostic factors and salvage therapy in 101 patients (pts) with AML in 1st relapse. All pts were treated as 1st line according protocols GOELAMs 1 (87–94) or 2 (95–99). They all achieved complete remission after one (85%) or two (16%) induction with a combination of anthracycline and cytarabine. Consolidation therapy included one course of high-dose cytarabine (HiDAC) and a second consolidation (amsacrine-VP16) or, for a subset of pts, intensification with allogeneic or autologous stem cell transplantation (SCT). Data were collected in 3 of the centers participating to these trials. Main characteristics of pts at initial diagnosis were: median age : 39 y (range 17–64); sex : 55 male, 46 female; WBC count > 30 000/μl in 42 (42%) pts; 16/85 (18%) pts had unfavorable karyotype. Median duration of 1st complete remission (CR1) was 10 months (range: 1–101). Duration of CR1 was shorter than 6 months in 22 (22%) pts, between 6 and 12 months in 41 (40%) pts and longer than 12 months in 38 (38%) pts. At time of 1st relapse, median age was 40 y (range 18–66) and 10/38 (26%) unfavorable karyotype. There were no specific recommendations in the GOELAMs protocols for the second line therapy: modalities of treatment were therefore left to investigator’s decision. First step of relapse treatment was based on intensive chemotherapy in 79 (79%) pts including 55 pts who received a regimen containing HiDAC (Group 1) and 24 pts who received a chemotherapy without HiDAC (Group 2). Eight pts received an autologous SCT (4 pts) or an allogeneic SCT (4 pts) without any previous salvage chemotherapy (Group 3). One pt received gemtuzumab ozogamicin and thirteen pts received only oral chemotherapy and/or supportive care (Group 4). Fifty-seven pts (56%) achieved a second CR. Response rate and median survival according to initial therapy of relapse are shown in the following table. Differences are not significant. Complete response (%) Median survival (months) Group 1 (n = 55) 39 (71%) 11.5 Group 2 (n = 24 10 (42%) 8 Group 3 (n = 8) 6 (75%) 7.5 Group 4 (n = 14) 2 (14%) 3.5 Twenty seven pts out of the 49 pts who achieved a CR2 after intensive chemotherapy (Group 1 and 2) received subsequent intensification with either an allogeneic SCT (7 pts) or an autologous SCT (20 pts). Median survival of these pts subsequently transplanted was 18 months compared to only 10 months in the 22 pts of group 1 and 2 who did not receive a subsequent transplantation. Difference is not significant (log rank test, p = 0.65). Nine (33%) of the 27 transplanted pts are alive more than 36 months after relapse (range 41–120). Univariate analysis demonstrated that adverse prognosis factors on survival at 1st relapse were duration of RC1 shorter than 12 months (p= 0.005)and complex cytogenetic abnormalities (p= 0.0086). Conclusion: Intensive chemotherapy including HiDAC at 1st relapse in AML in adults provided a high rate of complete response. Intensification with SCT after CR2 was obtained can provide a very long survival in a limited number of pts. At 1st relapse, adverse prognostic factors on survival were short CR1 and unfavorable karyotype. Risk-adapted of AML in first relapse may therefore be warranted. Figure Figure

In-vivo evaluation of the effect of cyanoacrylate on prosthetic vascular graft infection – does cyanoacrylate increase the severity of infection?

VASA ◽  
2020 ◽  
Vol 49 (4) ◽  
pp. 281-284
Author(s):  
Atıf Yolgosteren ◽  
Gencehan Kumtepe ◽  
Melda Payaslioglu ◽  
Cuneyt Ozakin
Keyword(s):  
Vascular Graft ◽  
Graft Infection ◽  
Vascular Graft Infection ◽  
Group 4 ◽  
Significant Difference ◽  
Group 3 ◽  
Group 2 ◽  
Prosthetic Vascular Graft Infection ◽  
Group 1

Summary. Background: Prosthetic vascular graft infection (PVGI) is a complication with high mortality. Cyanoacrylate (CA) is an adhesive which has been used in a number of surgical procedures. In this in-vivo study, we aimed to evaluate the relationship between PVGI and CA. Materials and methods: Thirty-two rats were equally divided into four groups. Pouch was formed on back of rats until deep fascia. In group 1, vascular graft with polyethyleneterephthalate (PET) was placed into pouch. In group 2, MRSA strain with a density of 1 ml 0.5 MacFarland was injected into pouch. In group 3, 1 cm 2 vascular graft with PET piece was placed into pouch and MRSA strain with a density of 1 ml 0.5 MacFarland was injected. In group 4, 1 cm 2 vascular graft with PET piece impregnated with N-butyl cyanoacrylate-based adhesive was placed and MRSA strain with a density of 1 ml 0.5 MacFarland was injected. All rats were scarified in 96th hour, culture samples were taken where intervention was performed and were evaluated microbiologically. Bacteria reproducing in each group were numerically evaluated based on colony-forming unit (CFU/ml) and compared by taking their average. Results: MRSA reproduction of 0 CFU/ml in group 1, of 1410 CFU/ml in group 2, of 180 200 CFU/ml in group 3 and of 625 300 CFU/ml in group 4 was present. A statistically significant difference was present between group 1 and group 4 (p < 0.01), between group 2 and group 4 (p < 0.01), between group 3 and group 4 (p < 0.05). In terms of reproduction, no statistically significant difference was found in group 1, group 2, group 3 in themselves. Conclusions: We observed that the rate of infection increased in the cyanoacyrylate group where cyanoacrylate was used. We think that surgeon should be more careful in using CA in vascular surgery.

Does Perioperative Hemoglobin A1c Level Affect the Incidence, Pattern and Mortality of Lower Extremity Amputation?

2019 ◽  
Vol 17 (4) ◽  
pp. 354-364
Author(s):  
Hassan Al-Thani ◽  
Moamena El-Matbouly ◽  
Maryam Al-Sulaiti ◽  
Noora Al-Thani ◽  
Mohammad Asim ◽  
...  
Keyword(s):  
Glycemic Control ◽  
Lower Extremity ◽  
Hazard Ratio ◽  
Lower Extremity Amputation ◽  
Group 4 ◽  
Group 3 ◽  
Group 5 ◽  
Group 2 ◽  
Extremity Amputation ◽  
Group 1

Background: We hypothesized that perioperative HbA1c influenced the pattern and outcomes of Lower Extremity Amputation (LEA). Methods: A retrospective analysis was conducted for all patients who underwent LEA between 2000 and 2013. Patients were categorized into 5 groups according to their perioperative HbA1c values [Group 1 (<6.5%), Group 2 (6.5-7.4%), Group 3 (7.5-8.4%), Group 4 (8.5-9.4%) and Group 5 (≥9.5%)]. We identified 848 patients with LEA; perioperative HbA1c levels were available in 547 cases (Group 1: 18.8%, Group 2: 17.7%, Group 3: 15.0%, Group 4: 13.5% and Group 5: 34.9%). Major amputation was performed in 35%, 32%, 22%, 10.8% and 13.6%, respectively. Results: The overall mortality was 36.5%; of that one quarter occurred during the index hospitalization. Mortality was higher in Group 1 (57.4%) compared with Groups 2-5 (46.9%, 38.3%, 36.1% and 31.2%, respectively, p=0.001). Cox regression analysis showed that poor glycemic control (Group 4 and 5) had lower risk of mortality post-LEA [hazard ratio 0.57 (95% CI 0.35-0.93) and hazard ratio 0.46 (95% CI 0.31-0.69)]; this mortality risk persisted even after adjustment for age and sex but was statistically insignificant. The rate of LEA was greater among poor glycemic control patients; however, the mortality was higher among patients with tight control. Conclusion: The effects of HbA1c on the immediate and long-term LEA outcomes and its therapeutic implications need further investigation.

Association between cervical disc disease and lesions of multiple sclerosis

2021 ◽  
pp. 197140092098356
Author(s):  
Marwan Alkrenawi ◽  
Michael Osherov ◽  
Azaria Simonovich ◽  
Jonathan Droujin ◽  
Ron Milo ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Cervical Disc ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Group 4 ◽  
Demyelinating Lesions ◽  
Grade Ii ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Background Cervical discopathy and demyelinating lesions often co-exist in patients with multiple sclerosis (MS). Our study examines the possible association between these two pathologies. Methods Medical records and cervical magnetic resonance imaging scans of MS patients with cervical discopathy who were seen at our MS clinic during 2018 were retrospectively reviewed. The severity of the disc disease was classified as grade I (no compression), grade II (compression of the dural sac) and grade III (cord compression). The spinal cord in each scan was divided into six segments corresponding to the intervertebral space of the spine (C1–C6). Each segment was defined as containing demyelinating lesion and disc pathology (group 1), demyelinating lesion without disc pathology (group 2), disc pathology without demyelinating lesion (group 3) and no demyelinating lesion or disc pathology (group 4). Fisher’s exact test was used to test the association between demyelinating lesions and disc pathology. Results Thirty-four MS patients with cervical discopathy were included in the study (26 females; average age 42.9 ± 13.7 years; average disease duration 8.4 ± 5.4 years). A total of 204 spinal cord segments were evaluated. Twenty-four segments were classified as group 1, 27 segments as group 2, 52 segments as group 3 and 101 segments as group 4. There was no association between demyelinating lesions and the grade of disc disease ( p = 0.1 for grade I, p = 0.3 for grade II and p = 1 for grade III disc disease). Conclusion Our study did not find any association between cervical disc disease and demyelinating spinal cord lesion.

scholarly journals Association between serum oestradiol level on the hCG administration day and neonatal birthweight after IVF-ET among 3659 singleton live births

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yu Liu ◽  
Jing Li ◽  
Wanyu Zhang ◽  
Yihong Guo
Keyword(s):  
Birth Weight ◽  
Ovarian Stimulation ◽  
Group 4 ◽  
Group 6 ◽  
Group 3 ◽  
Group 5 ◽  
Group 2 ◽  
The Impact ◽  
Ivf Et ◽  
Group 1

AbstractOestradiol, an important hormone in follicular development and endometrial receptivity, is closely related to clinical outcomes of fresh in vitro fertilization-embryo transfer (IVF-ET) cycles. A supraphysiologic E2 level is inevitable during controlled ovarian hyper-stimulation (COH), and its effect on the outcome of IVF-ET is controversial. The aim of this retrospective study is to evaluate the association between elevated serum oestradiol (E2) levels on the day of human chorionic gonadotrophin (hCG) administration and neonatal birthweight after IVF-ET cycles. The data of 3659 infertile patients with fresh IVF-ET cycles were analysed retrospectively between August 2009 and February 2017 in First Hospital of Zhengzhou University. Patients were categorized by serum E2 levels on the day of hCG administration into six groups: group 1 (serum E2 levels ≤ 1000 pg/mL, n = 230), group 2 (serum E2 levels between 1001 and 2000 pg/mL, n = 524), group 3 (serum E2 levels between 2001 and 3000 pg/mL, n = 783), group 4 (serum E2 levels between 3001 and 4000 pg/mL, n = 721), group 5 (serum E2 levels between 4001 and 5000 pg/mL, n = 548 ), and group 6 (serum E2 levels > 5000 pg/mL, n = 852). Univariate linear regression was used to evaluate the independent correlation between each factor and outcome index. Multiple logistic regression was used to adjust for confounding factors. The LBW rates were as follows: 3.0% (group 1), 2.9% (group 2), 1.9% (group 3), 2.9% (group 4), 2.9% (group 5), and 2.0% (group 6) (P = 0.629), respectively. There were no statistically significant differences in the incidences of neonatal LBW among the six groups. We did not detect an association between peak serum E2 level during ovarian stimulation and neonatal birthweight after IVF-ET. The results of this retrospective cohort study showed that serum E2 peak levels during ovarian stimulation were not associated with birth weight during IVF cycles. In addition, no association was found between higher E2 levels and increased LBW risk. Our observations suggest that the hyper-oestrogenic milieu during COS does not seem to have adverse effects on the birthweight of offspring after IVF. Although this study provides some reference, the obstetric-related factors were not included due to historical reasons. The impact of the high estrogen environment during COS on the birth weight of IVF offspring still needs future research.

scholarly journals Control of Vulval Competence and Centering in the Nematode Oscheius sp. 1 CEW1

Genetics ◽  
2003 ◽  
Vol 163 (1) ◽  
pp. 133-146 ◽  
Author(s):  
Sophie Louvet-Vallée ◽  
Irina Kolotuev ◽  
Benjamin Podbilewicz ◽  
Marie-Anne Félix
Keyword(s):  
Germ Line ◽  
Specific Mechanism ◽  
C Elegans ◽  
Group 4 ◽  
Cell Ablation ◽  
Group 3 ◽  
Group 2 ◽  
P Cells ◽  
Large Category ◽  
Group 1

Abstract To compare vulva development mechanisms in the nematode Oscheius sp. 1 to those known in Caenorhabditis elegans, we performed a genetic screen for vulva mutants in Oscheius sp. 1 CEW1. Here we present one large category of mutations that we call cov, which affect the specification of the Pn.p ventral epidermal cells along the antero-posterior axis. The Pn.p cells are numbered from 1 to 12 from anterior to posterior. In wild-type Oscheius sp. 1 CEW1, the P(4-8).p cells are competent to form the vulva and the progeny of P(5-7).p actually form the vulva, with the descendants of P6.p adopting a central vulval fate. Among the 17 mutations (defining 13 genes) that we characterize here, group 1 mutations completely or partially abolish P(4-8).p competence, and this correlates with early fusion of the Pn.p cells to the epidermal syncytium. In this group, we found a putative null mutation in the lin-39 HOM-C homolog, the associated phenotype of which could be weakly mimicked by injection of a morpholino against Osp1-lin-39 in the mother’s germ line. Using cell ablation in a partially penetrant competence mutant, we show that vulval competence is partially controlled by a gonadal signal. Most other mutants found in the screen display phenotypes unknown in C. elegans. Group 2 mutants show a partial penetrance of Pn.p competence loss and an abnormal centering of the vulva on P5.p, suggesting that these two processes are coregulated by the same pathway in Oscheius sp. 1. Group 3 mutants display an enlarged competence group that includes P3.p, thus demonstrating the existence of a specific mechanism inhibiting P3.p competence. Group 4 mutants display an abnormal centering of the vulval pattern on P7.p and suggest that a specific mechanism centers the vulval pattern on a single Pn.p cell.

scholarly journals Hypertrophy of unaffected cardiomyocytes correlates with severity of cardiomyopathy in female patients with Fabry disease

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Cristina Chimenti ◽  
Romina Verardo ◽  
Andrea Frustaci
Keyword(s):  
Fabry Disease ◽  
Wall Thickness ◽  
Left Ventricular ◽  
Female Patients ◽  
Maximal Wall Thickness ◽  
Group 4 ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Aim To investigate the contribution of unaffected cardiomyocytes in Fabry disease cardiomyopathy. Findings Left ventricular (LV) endomyocardial biopsies from twenty-four females (mean age 53 ± 11 ys) with Fabry disease cardiomyopathy were studied. Diagnosis of FD was based on the presence of pathogenic GLA mutation, Patients were divided in four groups according with LV maximal wall thickness (MWT): group 1 MWT ≤ 10.5 mm, group 2 MWT 10.5–15 mm, group 3 MWT 16–20 mm, group 4 MWT > 20 mm. At histology mosaic of affected and unaffected cardiomyocytes was documented. Unaffected myocytes’ size ranged from normal to severe hypertrophy. Hypertrophy of unaffected cardiomyocytes correlated with severity of MWT (p < 0.0001, Sperman r 0,95). Hypertrophy of unaffected myocytes appear to concur to progression and severity of FDCM. It is likely a paracrine role from neighboring affected myocytes.

scholarly journals THU0227 CAFFEINE INTAKE MODULATES DISEASE ACTIVITY AND CYTOKINES LEVELS IN SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 340.2-341
Author(s):  
V. Orefice ◽  
F. Ceccarelli ◽  
C. Barbati ◽  
R. Lucchetti ◽  
G. Olivieri ◽  
...  
Keyword(s):  
Disease Activity ◽  
Lupus Erythematosus ◽  
Caffeine Intake ◽  
Caffeine Consumption ◽  
Group 4 ◽  
Group 3 ◽  
Group 2 ◽  
The Impact ◽  
Group 1

Background:Systemic lupus erythematosus (SLE) is an autoimmune disease mainly affecting women of childbearing age. The interplay between genetic and environmental factors may contribute to disease pathogenesis1. At today, no robust data are available about the possible contribute of diet in SLE. Caffeine, one of the most widely consumed products in the world, seems to interact with multiple components of the immune system by acting as a non-specific phosphodiesterase inhibitor2.In vitrodose-dependent treatment with caffeine seems to down-regulate mRNA levels of key inflammation-related genes and similarly reduce levels of different pro-inflammatory cytokines3.Objectives:We evaluated the impact of caffeine consumption on SLE-related disease phenotype and activity, in terms of clinimetric assessment and cytokines levels.Methods:We performed a cross-sectional study, enrolling consecutive patients and reporting their clinical and laboratory data. Disease activity was assessed by SLE Disease Activity Index 2000 (SLEDAI-2k)4. Caffeine intake was evaluated by a 7-day food frequency questionnaire, including all the main sources of caffeine. As previously reported, patients were divided in four groups according to the daily caffeine intake: <29.1 mg/day (group 1), 29.2-153.7 mg/day (group 2), 153.8-376.5 mg/day (group 3) and >376.6 mg/day (group 4)5. At the end of questionnaire filling, blood samples were collected from each patient to assess cytokines levels. These were assessed by using a panel by Bio-Plex assays to measure the levels of IL-6, IL-10, IL-17, IL-27, IFN-γ, IFN-α and Blys.Results:We enrolled 89 SLE patients (F/M 87/2, median age 46 years, IQR 14; median disease duration 144 months, IQR 150). The median intake of caffeine was 195 mg/day (IQR 160.5). At the time of the enrollment, 8 patients (8.9%) referred a caffeine intake < 29.1 mg/day (group 1), 27 patients (30.3%) between 29.2 and 153.7 mg/day (group 2), 45 patients (51%) between 153.8 and 376.5 mg/day (group 3) and 9 patients (10.1%) >376.6 mg/day (group 4). A negative correlation between the levels of caffeine and disease activity, evaluated with SLEDAI-2K, was observed (p=0.01, r=-0.26). By comparing the four groups, a significant higher prevalence of lupus nephritis, neuropsychiatric involvement, haematological manifestations, hypocomplementemia and anti-dsDNA positivity was observed in patients with less intake of caffeine (figure 1 A-E). Furthermore, patients with less intake of caffeine showed a significant more frequent use of glucocorticoids [group 4: 22.2%,versusgroup 1 (50.0%, p=0.0001), group 2 (55.5%, p=0.0001), group 3 (40.0%, p=0.009)]. Moving on cytokines analysis, a negative correlation between daily caffeine consumption and serum level of IFNγ was found (p=0.03, r=-0.2) (figure 2A); furthermore, patients with more caffeine intake showed significant lower levels of IFNα (p=0.02, figure 2B), IL-17 (p=0.01, figure 2C) and IL-6 (p=0.003, figure 2D).Conclusion:This is the first report demonstrating the impact of caffeine on SLE disease activity status, as demonstrated by the inverse correlation between its intake and both SLEDAI-2k values and cytokines levels. Moreover, in our cohort, patients with less caffeine consumption seems to have a more severe disease phenotype, especially in terms of renal and neuropsychiatric involvement. Our results seem to suggest a possible immunoregulatory dose-dependent effect of caffeine, through the modulation of serum cytokine levels, as already suggested byin vitroanalysis.References:[1]Kaul et alNat. Rev. Dis. Prim.2016; 2. Aronsen et alEurop Joul of Pharm2014; 3. Iris et alClin Immun.2018; 4. Gladman et al J Rheumatol. 2002; 5. Mikuls et alArth Rheum2002Disclosure of Interests:Valeria Orefice: None declared, Fulvia Ceccarelli: None declared, cristiana barbati: None declared, Ramona Lucchetti: None declared, Giulio Olivieri: None declared, enrica cipriano: None declared, Francesco Natalucci: None declared, Carlo Perricone: None declared, Francesca Romana Spinelli Grant/research support from: Pfizer, Consultant of: Novartis, Gilead, Lilly, Sanofi, Celgene, Speakers bureau: Lilly, cristiano alessandri Grant/research support from: Pfizer, Guido Valesini: None declared, Fabrizio Conti Speakers bureau: BMS, Lilly, Abbvie, Pfizer, Sanofi

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