scholarly journals Risk of malignancy and biologic therapy in rheumatic inflammatory diseases: A single-center experience

2020 ◽  
Vol 1 (1) ◽  
pp. 39-45
Author(s):  
Laura Cometi ◽  
Cosimo Bruni ◽  
Saverio Passavanti ◽  
Lorenzo Tofani ◽  
Francesca Bartoli ◽  
...  
Keyword(s):  
Biologic Therapy ◽  
Inflammatory Diseases ◽  
Malignant Neoplasms ◽  
Lung Cancers ◽  
Single Center Experience ◽  
Non Melanoma Skin Cancer ◽  
Risk Of Malignancy ◽  
Immunosuppressive Action ◽  
Necrosis Factor ◽  
Melanoma Skin

AbstractObjectivesBiologic disease modifying anti-rheumatic drugs (bDMARDs) have significantly improved the care of patients with rheumatic muscle-skeletal disorders (RMDs). Considering their immunosuppressive action, a theoretical increase of malignancy risk has been a major concern in the last few decades. The objective of this study is to analyze the incidence of malignancies in a cohort of patients affected by rheumatoid arthritis (RA), psoriathic arthritis (PsA), and ankylosing spondylitis (AS) treated with bDMARDs.MethodsThe charts of bDMARD-treated RMD patients were reviewed, and data about bDMARD exposure and malignant cancers (excluding non-melanoma skin cancer) were collected.Results921 patients were included (median age: 50.59 years, 66.67% females); 1374 bDMARD treatments were administered, 87.12% were tumor necrosis factor inhibitors. A total of 21 malignant neoplasms were detected in 21 patients (61.90% females, median age at cancer diagnosis: 64.99 years), 66.67% in RA patients, 19.05% in PsA, and 14.28% in AS. Among them, 10 patients (47.62%) were treated with etanercept, 6 patients (28.57%) with adalimumab, and 1 case each with tocilizumab, certolizumab, golimumab, infliximab, and abatacept. The most common malignancies that we found were lung cancers, ductal mammary carcinomas, melanomas, and lymphomas. The incidence rate (IR) of malignancies in our cohort was 3.47 per 1000 person-years (p-y); the higher IRs were in RA patients (5.13 per 1000 p-y), in males (4.21 per 1000 p-y), and in patients aged >70 years (10.14 per 1000 p-y).ConclusionsThe results of our study showed IR of malignancies in RMD patients treated with bDMARDs that is in agreement with literature data.

Pharmacologic Immunomodulation and Cutaneous Malignancy in Rheumatoid Arthritis, Psoriasis, and Psoriatic Arthritis

2010 ◽  
Vol 37 (11) ◽  
pp. 2205-2215 ◽  
Author(s):  
MICHAEL S. KRATHEN ◽  
ALICE B. GOTTLIEB ◽  
PHILIP J. MEASE
Keyword(s):  
Rheumatoid Arthritis ◽  
Psoriatic Arthritis ◽  
Skin Cancer ◽  
Cell Carcinoma ◽  
English Language ◽  
Immunomodulatory Therapy ◽  
Cutaneous Malignancy ◽  
Non Melanoma Skin Cancer ◽  
Necrosis Factor ◽  
Melanoma Skin

Objective.It is unclear if skin cancer risk is affected by the use of immunomodulatory medications in rheumatoid arthritis (RA), psoriasis, and psoriatic arthritis (PsA). The purpose of this study is to evaluate and summarize the available data pertinent to this question.Methods.The English language literature on PubMed was searched with a combination of phrases, including “malignancy,” “skin cancer,” “squamous cell carcinoma,” “basal cell carcinoma,” “melanoma,” “psoriasis,” “psoriatic arthritis,” and “rheumatoid arthritis” in addition to the generic names of a variety of common immunomodulatory drugs. Relevant articles were identified and data were extracted.Results.In total, 2218 potentially relevant articles were identified through the search process. After further screening, 20 articles relevant to RA were included. An additional 19 articles relevant to either psoriasis or PsA were included as well. RA may be a risk factor for the development of cutaneous malignancy. Treatment with tumor necrosis factor inhibitors increases the rates of non-melanoma skin cancer (NMSC) in RA and psoriasis. This risk doubles when combination methotrexate therapy is used in RA. Methotrexate may increase the risk of malignant melanoma in patients with RA and the risk of NMSC in psoriasis. Cyclosporine and prior phototherapy significantly increase the risk of NMSC.Conclusion.RA may potentiate the risk of cutaneous malignancy and therefore dermatologic screening in this population should be considered. The use of immunomodulatory therapy in RA, psoriasis, and PsA may further increase the risk of cutaneous malignancy and therefore dermatologic screening examinations are warranted in these groups. More careful recording of skin cancer development during clinical trials and cohort studies is necessary to further delineate the risks of immunomodulatory therapy.

scholarly journals P334 Tofacitinib for the treatment of Ulcerative Colitis: Analysis of malignancy rates from the Ulcerative Colitis clinical programme

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S357-S359
Author(s):  
R C Ungaro ◽  
M A Ciorba ◽  
G Rogler ◽  
A I Sharara ◽  
N Sunna ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Incidence Rates ◽  
Open Label ◽  
Non Melanoma Skin Cancer ◽  
Daily Dose ◽  
Adjudication Committee ◽  
Necrosis Factor ◽  
Maintenance Study ◽  
Melanoma Skin

Abstract Background Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). We present an updated analysis of adjudicated malignancies in the tofacitinib UC clinical programme, including final data from the open-label, long-term extension (OLE) study (as of 24 Aug 2020). Methods Malignancies were evaluated from 3 randomised, placebo-controlled studies (2 Phase [P]3 induction studies [NCT01465763; NCT01458951]; 1 P3 maintenance study [NCT01458574]) and an OLE study (NCT01470612). Three cohorts were analysed: Induction (P3 induction studies), Maintenance (P3 maintenance study) and Overall (patients receiving tofacitinib 5 or 10 mg twice daily [BID] in P3 or OLE studies; data from the previous data cut [May 2019] are also reported for comparison). Analysis was by predominant dose (PD) 5 or 10 mg BID, based on average daily dose <15 mg or ≥15 mg, respectively (82.1% of patients received PD 10 mg BID). An independent adjudication committee reviewed potential malignancies. Proportions and incidence rates (IRs; unique patients with events per 100 patient-years of exposure) were evaluated for malignancies (excluding non-melanoma skin cancer [NMSC]) and NMSC. Results 1124 patients were evaluated for malignancies (2809.4 patient-years of tofacitinib exposure; up to 7.8 years of treatment; median duration of 685.5 days). No malignancies (excluding NMSC) occurred in Induction Cohort patients. Malignancies (excluding NMSC) occurred in 1 Maintenance Cohort patient (who was receiving placebo) and in 25 Overall Cohort patients (IR 0.86 [95% confidence interval (CI) 0.56, 1.27]: PD tofacitinib 5 mg BID n=5, IR 0.63 [95% CI 0.20, 1.47]; PD tofacitinib 10 mg BID n=20, IR 0.95 [95% CI 0.58, 1.46]); 5 new cases since May 2019 (Table).1 NMSC events in the Induction and Maintenance Cohorts were previously reported (Table).1 NMSC events occurred in 21 Overall Cohort patients (IR 0.73 [95% CI 0.45, 1.12]): PD tofacitinib 5 mg BID n=5, IR 0.63 (95% CI 0.21, 1.48); PD tofacitinib 10 mg BID n=16, IR 0.77 (95% CI 0.44, 1.25); 2 new cases since May 2019 (Table).1 Conclusion There was no apparent clustering of types of malignancy, excluding NMSC. Malignancies (excluding NMSC) and NMSC IRs remained stable over time, being comparable to those previously reported in the tofacitinib UC clinical programme.1 In this analysis, malignancies (excluding NMSC) and NMSC IRs were similar to those in patients with UC treated with tumour necrosis factor inhibitors, as reported from claims data (IRs of 0.63 and 1.69, respectively).2 References

scholarly journals Risk of non-melanoma skin cancer with biological therapy in common inflammatory diseases: a systemic review and meta-analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ruolin Liu ◽  
Qianyi Wan ◽  
Rui Zhao ◽  
Haitao Xiao ◽  
Ying Cen ◽  
...  
Keyword(s):  
Skin Cancer ◽  
Biological Therapy ◽  
Inflammatory Diseases ◽  
Meta Analysis ◽  
Systemic Review ◽  
Current Evidence ◽  
Cochrane Library ◽  
Non Melanoma Skin Cancer ◽  
Increased Risk ◽  
Melanoma Skin

Abstract Background Most previous studies compared the risk for non-melanoma skin cancer (NMSC) in biologic-treated common inflammatory diseases with the general population. Whether the increased NMSC risk is caused by the disease itself, the biologics, or both remains unknown. Methods We systematically searched PubMed, Embase, Medline, Web of Science, and Cochrane Library from inception to May 2021. Studies were included if they assessed the risk of NMSC for rheumatoid arthritis (RA), inflammatory bowel disease (IBD), or psoriasis patients treated with biologics compared with patients not receiving biologics. Pooled relative risks (RRs) and 95% confidence intervals (CIs) were calculated using the fixed- or random-effects model. Results The current meta-analysis included 12 studies. Compared with patients with the inflammatory disease without biologics, patients receiving biological therapy were associated with an increased risk for NMSC (RR 1.25, 95% CI 1.14 to 1.37), especially in patients with RA (RR 1.24, 95% CI 1.13 to 1.36) and psoriasis (RR 1.28, 95% CI 1.07 to 1.52), but not in patients with IBD (RR 1.49, 95% CI 0.46 to 4.91). The risks for squamous cell skin cancer and basal cell skin cancer were both increased for patients receiving biologics. However, the risk of NMSC did not increase in patients treated with biologics less than 2 years. Conclusions Current evidence suggests that increased risk of NMSC was identified in RA and psoriasis treated with biologics compared with patients not receiving biologics, but not in patients with IBD. The inner cause for the increased risk of NMSC in IBD patients should be further discussed.

scholarly journals Incidence of Skin Cancer in Patients With Chronic Inflammatory Cutaneous Diseases on Targeted Therapies: A Systematic Review and Meta-Analysis of Observational Studies

2021 ◽  
Vol 11 ◽  
Author(s):  
Salvatore Crisafulli ◽  
Lucrezia Bertino ◽  
Andrea Fontana ◽  
Fabrizio Calapai ◽  
Ylenia Ingrasciotta ◽  
...  
Keyword(s):  
Observational Studies ◽  
Inflammatory Diseases ◽  
Meta Analysis ◽  
Drug Induced ◽  
Skin Cancers ◽  
Organ Systems ◽  
Risk Of Malignancy ◽  
Inflammatory State ◽  
Meta Analyses ◽  
Melanoma Skin

Cancer is one of the several comorbidities that have been linked with chronic cutaneous inflammatory diseases namely psoriasis/psoriatic arthritis and hidradenitis suppurativa. Although the chronic inflammatory state, typical of the diseases, may induce pro-tumorigenic effects, the debate whether or not the drugs currently used in clinical practice do in facts increase a patient’s risk of malignancy remains largely unsolved. The therapeutic armamentarium has been greatly enhanced at least in the last two decades with the advent of biologics, a heterogeneous group of laboratory-engineered agents with more in the pipeline, and other targeted small molecules. Among the organ systems, skin results as one of the most commonly affected, non-melanoma skin cancers being the main drug-induced manifestations as side effect in course of these treatments. The objective of the study is to systematically review the cutaneous malignancy risk of the newer therapies through an overview of meta-analyses and observational studies on the topic.

Epidemiology and clinical evolution of non-melanoma skin cancer in renal transplant recipients: a single-center experience in São Paulo, Brazil

2015 ◽  
Vol 54 (10) ◽  
pp. e383-e388 ◽  
Author(s):  
Marina Zoega Hayashida ◽  
Victor Miguel Coutinho Fernandes ◽  
Diana Rosa de Melo Fernandes ◽  
Marília Marufuji Ogawa ◽  
Jane Tomimori
Keyword(s):  
Skin Cancer ◽  
Renal Transplant ◽  
Sao Paulo ◽  
Renal Transplant Recipients ◽  
Transplant Recipients ◽  
Single Center ◽  
Clinical Evolution ◽  
Single Center Experience ◽  
Non Melanoma Skin Cancer ◽  
Melanoma Skin

Melanoma and non-Melanoma Skin Cancer in Inflammatory Bowel Disease Patients following Tumor Necrosis Factor-α Inhibitor Monotherapy and in Combination with Thiopurines: Analysis of the Food and Drug Administration Adverse Event Reporting System

2014 ◽  
Vol 23 (3) ◽  
pp. 267-271 ◽  
Author(s):  
Michael R. McKenna ◽  
Derrick J. Stobaugh ◽  
Parakkal Deepak
Keyword(s):  
Skin Cancer ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
P Value ◽  
Non Melanoma Skin Cancer ◽  
Tnf Α ◽  
Inflammatory Bowel ◽  
Necrosis Factor ◽  
Melanoma Skin

Background & Aims: Reports have shown an increased risk of melanoma skin cancer (MSC) with exposure to tumor necrosis factor alpha (TNF-α) inhibitors and non-melanoma skin cancer (NMSC) with thiopurine exposure in inflammatory bowel disease (IBD) patients. Using the Food and Drug Administration Adverse Event Reporting System (FAERS) we sought to evaluate the odds of developing MSC and NMSC for patients on TNF-α inhibitors as monotherapy and in combination therapy with thiopurines and/or steroids.Methods: The FAERS was queried for reports between January 2003 and June 2012. A proportional reporting ratio (PRR) metric analyses was performed on the data to determine the odds of developing MSC and NMSC.Results: The PRR analysis showed increased odds of developing MSC and NMSC for patients on a TNF-α inhibitor (p-value = 0.035 and p-value = 0.03, respectively) and those on a TNF-α inhibitor in combination with a thiopurine (p-value < 0.001 and p-value < 0.001).Conclusion: TNF-α inhibitor monotherapy or use with concomitant thiopurines in patients with IBD is associated with higher odds of developing MSC and NMSC.

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