Biological Therapy Group Research Articles

Biologic therapy increases Demodex density in psoriasis patients.

Demodex density is known to increase in various immunosuppressive conditions. The relationship between biologic therapy and Demodex density remains unknown. We aimed to investigate whether the density of Demodex mites is higher in psoriasis patients treated with biologic agents compared to treatment-naive or topically treated patients. A cross-sectional study was conducted, comparing psoriasis patients receiving biologic therapy (n = 34) with controls (n = 33). Demodex density was assessed using the standardized skin surface biopsy technique (SSSB). Statistical analysis was performed to compare the densities and prevalence of demodicosis between the two groups. Demodex density was significantly higher in the biologic therapy group compared to the control group on the right cheek (7.29 vs. 0.12/cm2; P = 0.001), left cheek (8.15 vs. 0.24/cm2; P = 0.002), and whole face (average of all four regions: 5.50 vs. 0.80/cm2; P = 0.001). The prevalence of demodicosis was significantly higher in the biologic therapy group on the forehead (35.3% vs. 12.1%; P = 0.043), right cheek (41.2% vs. 0%; P < 0.001), and left cheek (44.1% vs. 0%; P < 0.001). The frequency of cases with demodicosis in at least one localization was higher in the biological therapy group compared to the control group (61.8% vs. 15.2%; P < 0.001). Psoriasis patients receiving biologic therapy had a higher Demodex density and prevalence of demodicosis compared to controls. Biologics may lead to an increase in Demodex density by blocking specific cytokines, such as interleukin-17 and tumor necrosis factor-α, which play a role in immunity against Demodex. Further research is needed to explore the impact of different biological agents on Demodex density.

Efficacy and safety of SARS-CoV-2 vaccination in patients with inflammatory bowel disease on immunosuppressive and biological therapy: Prospective observational study.

Background and aimsSARS-CoV-2 is a worldwide serious health problem and vaccination seems to have a crucial role in managing the COVID-19 pandemic. The aim of this prospective observational study was to monitor the trend of antibodies against SARS-CoV-2 after vaccination with BNT162b2 (COMIRNATY) in patients with inflammatory bowel disease treated by immunosuppressive and/or biological therapy, demonstrate whether any type of this therapy is associated with poorer production of antibodies against COVID-19 and evaluate the safety of vaccination against COVID-19 in these patients.MethodsEighty-seven eligible patients from one tertiary gastroenterological center with inflammatory bowel disease (60 with CD, 27 with UC) treated by immunosuppressive and/or biological therapy from the antiTNFα group were indicated to vaccination against SARS-CoV-2. Effectiveness of vaccination was evaluated by the values of antibodies before and 4 weeks after 2nd dose of vaccine. Additional goal was to evaluate adverse events of vaccination.ResultsBefore the 2nd dose of vaccine, geometric mean of SARS-CoV-2 IgG antibodies were 40.7 U/ml in the biological therapy group, 34.8 U/ml in the azathioprine group and 44.8 U/ml in the combination therapy group of patients. The geometric means were 676.5.7 U/ml in the biological therapy group, 614.4 U/ml in the azathioprine group and 500.1 U/ml in the combination therapy group of patients four weeks after 2nd dose. Statistically significant differences between these groups were not proved. Several non-severe local and general adverse events were present in our patients with a majority of these events on the day of vaccine administration and the day after, no anaphylactic reactions were present.ConclusionsOur measurements proved the efficacy and safety of vaccination against SARS-CoV-2 in patients with inflammatory bowel disease treated by immunosuppressive and/or biological therapy. Statistically significant differences between our groups of patients were not proved.

PMS30 Healthcare related costs with biological therapy in patients with ankylosing spondylitis in rheumatology department from tertiary Hospital from Bogota, Colombia

To describe the direct costs of patients diagnosed with Ankylosing spondylitis at the Hospital Militar Central who presented therapeutic failure to conventional drugs and entered therapy with biological drugs. Economic evaluation study, estimation of direct costs of biological therapy in Ankylosing spondylitis. The methodology of costing by procedures and the identification of costing sequence, quantification and valuation of resources was used. With a complementary sensitivity analysis. The costs are presented adjusted in Colombian pesos and US dollars for 2019. 117 patients with a diagnosis of Ankylosing spondylitis were included, 63.2% men, age 46.4 ± 13.7 years, disease duration was 9.8 ± 9.6 years. The use of medication was DMARDs 49.6%, NSAIDs 64.1%, anti-TNF 40.2% and anti-IL-17 2.6%. Average annual direct costs / patient was $ 22,637,137 (6,872.2 USD), in the NSAID group $ 1,706,965, DMARDs $ 1,739,077 and biological therapy group $ 36,486,015. The costs related to EA are like those reported in the literature when adjusted for the purchasing power of parity. Understanding this aspect is the starting point to promote a more efficient distribution of the limited resources destined to the management and control of Ankylosing spondylitis.

Assessment of the State of Cell Membranes against the Background of Prolonged Use of Anticytokine Therapy in Patients with Ulcerative Colitis

Biological therapy in the treatment of immune-mediated conditions has changed their course, the quality of life of patients and the prognosis of diseases. The accumulated by mankind 20 years of experience with the use of genetically engineered drugs has led to a number of questions regarding, among other issues, safety in the long-term administration of biological therapy. Patients suffering from ulcerative colitis revealed changes in cell membranes, reflecting their structural and energy characteristics. Long-term administration of Infliximab leads to the stabilization of energy processes in the erythrocyte membrane and improves homeostatic function of the kidneys.The aim of the studywas to evaluate the effect of long-term use of TNF-α blockers (Infliximab) on the structural and functional characteristics of cell membranes and the functional state of the kidneys in patients with moderate to severe ulcerative colitis.Materials and methods. We examined 103 patients with moderate to severe ulcerative colitis during the period of acute attack and remission, of which 28 patients received basic therapy using the drug Infliximab (IFX) for 10 years, 75 patients received standard basic treatment. The patients of the biological therapy group took the original drug Infliximab – Remicade. The comparison group consisted of 30 healthy volunteers, comparable by sex and age. The analysis of the state of erythrocyte membranes was carried out using a set of physicochemical methods: UV spectroscopy (SF-46m spectrophotometer), high-performance thin-layer reaction paper chromatography, membrane ultrafiltration, erythrocyte NMR spectroscopy on phosphoric (31P) and proton (1H) nuclei. The functional state of the kidneys was evaluated using a dynamic scintigraphic study (with the technemage –Tc-99m).Results.Prolonged use of anticytokine therapy with Infliximab for 10 years in patients with ulcerative colitis, upon reaching deep remission, improves endogenous intoxication, restores the structural and functional characteristics of cell membranes, normalizes cell energy metabolism and does not negatively affect the functional state of the kidneys.

Anti-TNF therapy is able to stabilize bowel damage progression in patients with Crohn’s disease. A study performed using the Lémann Index

AimsThe Lémann Index (LI) was developed to assess the cumulative structural damage of the intestinal tract in patients with Crohn’s Disease (CD) independently of clinical and biochemical activity. Recently, the goal of CD focused on obtaining mucosal healing and deep remission rather than simple symptom control. These new therapeutic aims emphasize the need to prevent progression of bowel damage. In this study we aimed to evaluate the influence of different treatments on structural damage progression, assessed by means of LI in a series of CD patients consistently treated with various drugs. MethodsThe LI was calculated at inclusion and at the end of follow-up in 104 CD patients subdivided according to treatments received: biological drugs (n=40, 38.4%), azathioprine (n=19, 18.3%), and mesalazine (n=45, 43.3%). ResultsThe median follow-up was 29 months, with no difference among groups. During follow-up, the median LI was stable in the biological group [from 6.3 (range, 0.6–37.3) to 6.4 (range, 0.6–37.6), P=0.543], whereas it significantly increased from 4.1 (range, 0.6–30) to 8.3 (range, 0.6–31.8) in the azathioprine group (P=0.0006), and from 2.4 (range, 0.6–25.8) to 4.1 (range, 0.6–28.8) in the mesalazine group (P<0.0001). Also during follow-up the LI increased significantly (P=0.004) in the azathioprine (68.4%) and mesalazine (60.0%) groups as compared with the biological therapy group (30.0%). ConclusionsIn CD patients the LI tends to increase over time, although the use of biological drugs rather than azathioprine or mesalazine seems to be able to reduce the progressive bowel damage.

Linguistic Markers of Processing Trauma Experience in Women’s Written Narratives During Different Breast Cancer Phases: Implications for Clinical Interventions

Research into the change processes underlying the benefits of expressive writing is still incomplete. To fill this gap, we investigated the linguistic markers of change in cognitive and emotional processing among women with breast cancer, highlighting the differences and peculiarities during different treatment phases. A total of 60 writings were collected from 20 women: 10 receiving chemotherapy and 10 receiving biological therapy. We performed a series of repeated measures ANOVA for the most meaningful LIWC linguistic categories, including positive/negative emotions and cognitive processes, to assess change over three sessions. Results demonstrated a significant increase in the positive emotions category for the entire group of women, with particular relevance for the biological therapy group of women, and a marginally significant (p = .07) greater use of words indicating cognitive processes for women receiving biological therapy. For the negative emotions category time was significant for the whole group of women, showing a peak of use in the second session of writing. Peculiar differences in the linguistic markers of processing trauma were observed between the two groups. Although the writing intervention is a support for both groups of women, it seems to be beneficial when there is a large time gap since the administration of chemotherapy and, thus, when the patient can revisit the experience. The relationship of the illness with life can be rearticulated, and the writing becomes a space for resignifying the traumatic cancer experience.

AB1156-HPR Do Rheumatic Patients under Biological Therapy Receive More Attention from Their Doctors Compared with Those Who do not Receive Such Therapy?

BackgroundChronic rheumatic patients come in contact with health system more often than regular people that give them the opportunity to better identify both the strengths and weakness of this system....

Infecciones en pacientes con artritis reumatoide: medicamentos moduladores de la respuesta biológica versus fármacos modificadores de la enfermedad. Seguimiento a un año

BackgroundDisease modifying anti-rheumatic drugs and biological disease modifying drugs are used to control inflammation and prevent progression of joint damage in rheumatoid arthritis. It is still controversial whether these drugs increase the incidence of infection in this disease. MethodsA retrospective cohort study was conducted on a population sample of 383 inpatients and outpatients from a university hospital and referral rheumatology tertiary hospital complex in northwestern Colombia. They were classified according to American College of Rheumatology 1987 classification criteria, with 83 in the biological therapy group, and 300 in the disease modifying antirheumatic drugs group, in order to establish the incidence and risk factors for serious and non-serious infections at 12 months follow-up. ResultsThe majority were females (85%). The biological therapy group presented a greater risk for non-serious [HR 1.73 (95% CI 1.07–2.77; P=.023)] and serious infections [HR 2.56 (95% CI 1.09–6.01; P=.030)]. This finding remained when adjusting for other variables associated with infection (number of disease modifying antirheumatic drugs received, methotrexate, leflunomide and steroids use, diabetes mellitus), with HR for non-serious infection [(1.67, 95% CI 1.05–2.70; P=.030)], and HR for serious infection [(2.67, 95% CI 1.12–6.34; P=.026)]. Chronic lung disease [HR 5.11 (95% CI 1.18–22.08; P=.029)] was an additional risk factor for serious infections. ConclusionsBiological therapy increases the risk of serious and non-serious infections at 12 months, compared to disease modifying drugs, in a group of patients with rheumatoid arthritis. The risk of serious infections also increases with the presence of chronic lung disease

Investigation of effects of two-different treatment modalities on nerve conduction in patients with ankylosing spondylitis

The objective of this study was to investigate any relationship between peripheral neuropathy and anti-TNF-α therapy used in ankylosing spondylitis (AS). Thirty-nine patients monitored in our clinic with a diagnosis of AS and without neuropathic symptoms were enrolled in the study. Patients were divided into two groups. The first consisted of 21 patients using biological agents for more than one year. The control group was made up of 18 patients of similar age and demographic characteristics receiving non-biological therapy. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores were calculated, and sedimentation rate and C-reactive protein (CRP) levels measured. Motor and sensory nerve conduction analysis for the median, tibial, and sural nerves was performed. The nerve conduction results of the biological therapy group were then compared with those of the non-biological therapy group. Thirty-nine patients with a mean age of 37.05±8.1 were enrolled. Patients were divided into two groups, depending on drugs used. The first group (using anti-TNF-α) consisted of 21 patients with a mean age of 42.2±8.8, and the second (the non-biological group) of 18 patients with a mean age of 35.8±7.5. There was no statistically significant difference between the groups in terms of age, sex, drug use, or duration of disease (p=0.052, p=0.55, p=0.33, and p=0.72, respectively). Sedimentation rate, CRP, and BASDAI scores were statistically significantly higher in the second group (p=0.04, p=0.03, and p=0.009, respectively). No statistically significant difference was determined in any parameters at nerve conduction analysis between the two groups (p>0.05). There was a positive correlation between sedimentation rate and median sensory conduction velocity (p=0.02, r=0.48) and tibial conduction velocity (p=0.07, r=0.43). A negative correlation was determined between duration of disease and median distal motor latency (p=0.22, r=-0.37) and between length of drug use and median sensory conduction velocity (p=0.02, r=-0.38). There was no significant correlation between other clinical and demographic data and nerve conduction parameters. No effect on nerve conduction of biological agents in AS patients without neurological symptoms was determined. Clinicians should be alert for signs and symptoms, suggesting neuropathy in patients given anti-TNF-α.