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OBJECTIVE To evaluate the quality of guidelines/consensus on therapeutic drug monitoring (TDM) of anti-tumor necrosis factor-α (TNF-α) in patients with inflammatory bowel disease (IBD) in China and globally. METHODS PubMed, Embase, CNKI, Wanfang data, VIP, and release websites of guidelines/consensus in China and globally were searched to collect guidelines/expert consensus on TDM with anti-TNF-α for IBD patients. The search period was from database establishment to June 2023. After two investigators independently screened the literature and extracted the data, the methodological quality of the included guidelines/consensuses was evaluated using the Appraisal of Guidelines for Research and Evaluation Ⅱ. The main recommendations of the included guidelines/consensuses were summarized. RESULTS A total of 9 articles were included, 3 were guidelines and 6 were expert consensus. The standardized percentages of the 9 guidelines/consensus in the 6 dimensions (scope and aims, participants, rigor of formulation, clarity of expression, application, and editorial independence) were 90.43%, 41.98%, 52.55%, 85.49%, 19.00%, and 76.85%, respectively. Eight guidelines/consensus had a recommendation of grade B and one consensus of grade C. The main recommendations involve TDM application scenarios, threshold ranges, strategy adjustments, detection methods, and interpretation of results. Most guidelines/consensus recommend passive TDM for non-responders. It is recommended to set the TDM concentration range according to the expected treatment results and make strategy adjustments in combination with the disease condition and TDM results. Additionally, the same test method is recommended for the same patient. Some guidelines/consensus hold that no differences were noted in the interpretation of results between biosimilar and original drug. CONCLUSIONS The overall quality of the included guidelines/consensus was fair, with relatively consistent recommendation. Clinicians need to understand the characteristics and limitations of TDM with this class of drugs, and interpret and apply results of TDM in combination with specific clinical treatment goals.
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Pustulotic arthro-osteitis (PAO) is a rare chronic inflammatory disorder characterized by inflammatory osteitis of the sternoclavicular joint and palmoplantar pustulosis. Here, we report a case of PAO that was successfully treated with a TNF-α inhibitor. A 45-year-old man presented with a 3-month history of pustular eruption on the palms and soles. Physical examination showed multiple erythematous papulopustules on the palms, back, and left shin, accompanied by sternoclavicular joint swelling and tenderness. Skin biopsy showed intraepidermal pustules filled with neutrophils on the palm. Bone scintigraphy revealed increased uptake in the bilateral sternoclavicular and other axial joints. Based on these findings, we made the diagnosis of PAO. Even after 6-month treatment of oral steroids and cyclosporine, skin manifestations insufficiently improved, so etanercept therapy was started. Complete clearance of skin lesions and joint pain were achieved after 3 months of etanercept therapy.
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Humanos , Pessoa de Meia-Idade , Artralgia , Biópsia , Ciclosporina , Diagnóstico , Etanercepte , Articulações , Neutrófilos , Osteíte , Exame Físico , Cintilografia , Pele , Manifestações Cutâneas , Articulação Esternoclavicular , EsteroidesRESUMO
OBJECTIVE: To conduct methodology/reporting quality reevaluation for Meta-analysis/systematic evaluation of anti-TNF-α monoclonal antibody in the treatment of ulcerative colitis. METHODS: Retrieved from the Cochrane library, PubMed, Embase, CBM, Wanfang database and CNKI during data base establishment to Nov. 2018, Meta-analysis/systematic evaluations of anti-TNF-αmonoclonal antibody in the treatment of ulcerative colitis were collected. After data extraction of literatures that meet the inclusion criteria, methodological quality and reporting quality of included studies were evaluated by using AMSTAR scale and the PRISMA statement. RESULTS: Fourteen literatures of Meta-analysis/systematic evaluation were included. The average score of AMSTAR methodology quality (full score of 11 points) was 6.89, with medium methodological quality. PRISMA score (full score of 27 points) ranged from 15 to 26.5. CONCLUSIONS: Meta-analysis/systematic evaluations of anti-TNF-α monoclonal antibody for ulcerative colitis have poor methodological and reporting quality.
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Behçet's disease (BD) is a chronic relapsing disease involving multiple organ systems. BD is characterized clinically by oral and genital aphthae, cutaneous lesions, and ophthalmological, neurological, and/or gastrointestinal manifestations. It is widely recognized that the presence of intestinal lesions may be a poor prognostic factor in intestinal BD, increasing the risk of surgery and decreasing the quality of life. Despite this, the management of intestinal BD has not been standardized. Empirical therapies including 5-aminosalicylic acid and corticosteroids have been used anecdotally to treat intestinal BD, but recent studies have provided evidence for the efficacy of anti-tumor necrosis factor α monoclonal antibodies. The development of agents targeting tumor necrosis factor α continues, it seems likely that they will change the therapeutic strategy and clinical outcomes of intestinal BD and inflammatory bowel disease. Monitoring disease activity such as endoscopic evaluation will become more important to obtain better outcomes. Here, we review current and future perspectives in the treatment and outcomes of intestinal BD.
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Corticosteroides , Anticorpos Monoclonais , Doenças Inflamatórias Intestinais , Mesalamina , Necrose , Qualidade de Vida , Estomatite Aftosa , Fator de Necrose Tumoral alfaRESUMO
Objective To evaluate systematically the clinical efficacy of surgery combined with anti-TNFalpha in treatment of Crohn's disease (CD) with perianal fistula.Method Database including China Biology Medicine disc,Wan Fang Database,PubMed,Cochrane Library and EMBASE were searched withCrohn's disease,anal fistula,fistula,perianal fistula,surgical procedure,surgery,surgical,anti-tumor necrosis factoralpha,anti-TNF-alpha,TNF-alpha,克罗恩病,Crohn's病,肛瘘,手术治疗,外科手术,抗肿瘤坏死因子α制剂,肿瘤坏死因子,肿瘤坏死因子配体超家族员2”between the database establishment and June 2016.Literatures of retrospective case-control studies about surgery combined with anti-TNF-alpha therapy and single surgery in treatment of CD with perianal fistula were retrieved.Data were extracted and evaluated by 2 independent researchers.Patients who underwent surgery combined with anti-TNF-alpha therapy were allocated into the combined therapy group and patients who underwent single surgical treatment were allocated into the surgery group.The complete healing rate,partial healing rate and recurrence rate after therapy were compared between the 2 groups.Count data were represented as the odds ratio (OR) and 95% confidence interval (CI).The heterogeneity was analyzed by theI2 test.Result Six retrospective case-control studies were retrieved and total sample size was 598 patients,including 256 in the combined therapy group and 342 in the surgery group.The result of Meta analysis showed that there was no significant difference in postoperative complete healing rate and partial healing rate between the 2 groups (OR =1.36,1.47,95 % CI:0.94-1.97,0.56-3.88,P > 0.05),and recurrence rate after therapy in the combined therapy group was significantly lower than that in the surgery group (OR =0.26,95% CI:0.16-0.44,P < 0.05).Conclusion The complete healing rate and partial healing rate of patients with CD with perianal fistula undergoing surgery combined with anti-TNF-alpha therapy are not superior to that undergoing single surgical treatment,however,recurrence rate after therapy is lower for patients undergoing surgery combined with anti-TNF-alpha therapy.