Biologic Therapy In Patients Research Articles

Microfibrillar-associated protein 4 as a predictive biomarker of treatment response in patients with chronic inflammatory diseases initiating biologics: secondary analyses based on the prospective BELIEVE cohort study.

Currently, there are no reliable biomarkers for predicting treatment response in chronic inflammatory diseases (CIDs). To determine whether serum microfibrillar-associated protein 4 (MFAP4) levels can predict the treatment response to biological therapy in patients with CIDs. The BELIEVE study was originally designed as a prospective, multi-center cohort study of 233 patients with either rheumatoid arthritis, psoriatic arthritis, psoriasis, axial spondyloarthritis, Crohn's disease, or ulcerative colitis, initiating treatment with a biologic agent (or switching to another). Clinical assessment and blood sample collection were performed at baseline and 14-16 weeks after treatment initiation. The primary analyses included participants with available blood samples at baseline; missing data were handled as non-responders. The patients were stratified into the upper tertile of serum MFAP4 (High MFAP4) versus a combined category of middle and lower tertiles (Other MFAP4). The primary outcome was the proportion of patients with clinical response to biologic therapy after 14-16 weeks. 211 patients were included in the primary analysis population. The mean age was 43.7 (SD: 14.8) years, and 120 (59%) were female. Positive treatment response was observed in 41 (59%) and 69 (49%) for High MFAP4 and Other MFAP4, respectively. When adjusting for pre-specified variables (CID, age, sex, smoking status, and BMI), the adjusted OR was 2.28 (95% CI: 1.07 to 4.85) for a positive treatment outcome in the High MFAP4 group. A high MFAP4 status before initiating biological treatment is associated with a positive clinical response, when adjusting for confounding factors.

Factors influencing the discontinuation of biologic therapies in patients with ulcerative colitis

BackgroundThe therapeutic landscape for ulcerative colitis (UC) has recently broadened to include anti-TNFα, anti-integrin, and anti-IL-12/23p40 antibody agents. These biological agents are tailored to individual patient profiles. However, some patients cease biological treatment. This study investigates factors influencing the discontinuation of biological treatment in UC patients.MethodsThis retrospective single-cohort study encompasses UC patients who commenced treatment with biological agents like infliximab, adalimumab, golimumab, vedolizumab, and ustekinumab from April 2019 to March 2022. Patients were categorized into continuation and discontinuation groups based on their one-year treatment status. Baseline characteristics were compared between the groups.ResultsOf the 116 UC patients, 102 were included in the study. Among these, 74 (72.5%) continued and 28 (27.5%) discontinued biological therapy. Discontinuation rates for infliximab, adalimumab, golimumab, vedolizumab, and ustekinumab were 33.3%, 25.0%, 50.0%, 30.2%, and 15.6%, respectively. The primary discontinuation reason was lack of efficacy (85.7%), followed by adverse events (7.1%), pregnancy (3.6%), and death (3.6%). The discontinuation group had a significantly lower rate of concomitant thiopurine compared to the continuation group (28.6% vs. 56.8%, p = 0.0132). Multivariable analysis revealed that concomitant thiopurine was independently associated with therapy continuation (p = 0.0075).ConclusionThe study indicates that concomitant thiopurine significantly correlates with the continuation of biological therapies in UC patients, underscoring the importance of concomitant thiopurine in sustaining biological therapy. Further studies are warranted to assess the efficacy of combination therapy.

Use of Targeted Biologic Therapies in Asthma: Current Practice in India

Asthma remains a significant public health issue in India, with a growing number of patients experiencing severe and uncontrolled forms of the disease. Targeted biologic therapies, including omalizumab, mepolizumab, benralizumab, reslizumab, and dupilumab, have emerged as advanced treatment options for patients with severe asthma, especially those with allergic or eosinophilic phenotypes. These therapies work by targeting specific immunological pathways involved in asthma pathogenesis, offering better symptom control and reducing exacerbation rates. However, the high cost of biologics, limited access, and inconsistent insurance coverage pose significant barriers to their widespread use in India. Despite these challenges, real-world data from Indian studies demonstrate promising clinical outcomes with biologic therapies in patients with difficult-to-treat asthma. This review examines the current landscape of biologic use in India, challenges related to cost and accessibility, and future prospects for integrating these treatments into routine asthma care, particularly through cost- reduction strategies and expanded healthcare coverage.

The Association of Interleukin-36 Staining Intensity and Response to Biologic Therapy in Patients With Psoriasis: A Retrospective Immunohistochemical and Chart Review Pilot Study.

There are limited surrogate biomarkers to identify the active inflammatory pathway in psoriasis to direct treatment with targeted biologic therapies. We investigated the association of interleukin (IL)-36 epidermal expression, a diagnostic marker of psoriasis, with response to biologic therapy in patients with psoriasis. Retrospective immunohistochemical and chart review pilot study. Patients with psoriasis with low (scores 0-2) vs. high (scores 3-4) IL-36 expression did not have significantly different response rates to tumor necrosis factor α (TNFα), IL-17, and IL-12/23 or IL-23 inhibitors; and similarly, mean IL-36 expression scores did not significantly differ among responders vs. non-responders to each treatment mechanism. However, in patients with psoriasis treated with IL-12/23 or IL-23 inhibitors, there was a marked absolute difference in response rates in those with high vs. low IL-36 (84% vs. 50%, p = 0.12) and in mean IL-36 scores in responders vs. non-responders (3.35 vs. 2.57, p = 0.19). Patients with psoriasis with high IL-36 expression were more likely to respond to IL-12/23 and IL-23 inhibition than those with low IL-36, though these findings were not statistically significant. Additional studies with larger sample sizes are needed to validate and expand upon these findings.

S1113 Comparative Effectiveness of Second-Line Biologic Therapies in Patients With Moderate to Severe Ulcerative Colitis: A Population-Based Cohort Study

S1113 Comparative Effectiveness of Second-Line Biologic Therapies in Patients With Moderate to Severe Ulcerative Colitis: A Population-Based Cohort Study

The determinants associated with the prescription of a first biologic therapy in patients with axial spondyloarthritis and concomitant fibromyalgia are mostly objective and in line with the recommendations. Results of a cross-sectional survey-based study using a mixed (qualitative and quantitative) approach to help rheumatologists in their daily practice

ObjectivesThere is no consensus on the therapeutic strategy of rheumatologists for patients with spondyloarthritis (SpA) and concomitant fibromyalgia (FM). The main aim of this study was to identify, in a population of rheumatologists practicing in Normandy, France, the determinants associated with their decision to prescribe a first biologic DMARD (bDMARD) in patients with Spa/FM. Specific objectives were to evaluate professional prescribing practices to identify a set of criteria likely to contribute to the therapeutic decision of rheumatologists, and to validate the relevance of these criteria. MethodThis is a cross-sectional survey-based study using a mixed (qualitative and quantitative) method. The quantitative approach was web-based and conducted among rheumatologists in Normandy. ResultsThe qualitative study allowed us to identify a set of criteria likely to contribute to the therapeutic decision of rheumatologists. In the quantitative study, 54/113 rheumatologists filled the questionnaire. Four criteria were considered by all respondents to contribute to their decision to prescribe a first bDMARD: arthritis on physical examination, extra-articular manifestations, systemic inflammation and structural damage on imaging. ConclusionsThe determinants associated with the decision of rheumatologists to prescribe a first bDMARD in patients with SpA/FM were mostly objective, in line with the recommendations in the literature. Most criteria were more related to an approach aimed at ensuring the diagnosis of SpA than evaluating its activity or severity.

Predictors of initiating biologics in the treatment of psoriasis.

Biologics are among the most effective therapies for psoriasis. However, many patients are only introduced to them at advanced stages of the disease course. Our aim was to identify predictors of initiating biologic therapy in patients with psoriasis and compare patients initiating biologics early versus late in their disease course. Kaplan-Meier curves visualized time to biologic initiation, while Cox regression models further explored variables as predictors of biologic initiation. Mann-Whitney U and chi-squared tests compared patients who started biologics early with those who began biologics later in the disease course. Our primary analysis included 233 psoriasis patients. Cox regression showed that age at diagnosis (P = 0.007), general physical well-being (P = 0.02), and nail psoriasis severity (P = 0.02) were significantly associated with time to biologic initiation. Our secondary analysis, the comparisons between patients starting biologics early versus later in the disease course, included a total of 378 patients. The median (interquartile range [IQR]) age at diagnosis was 34.5 (25.0-51.2) years for patients initiating biologics within 5 years, compared to 22.0 (15.0-32.8) years for patients initiating biologics later (P < 0.0001). The median (IQR) age at initiation was 37.0 (27.0-53.2) and 45.0 (36.0-55.0) years for patients initiating biologics earlier versus later than 5 years (P = 0.04). Age at diagnosis, general well-being, and severity of nail psoriasis significantly predicted future initiation of biologic treatment. Patients initiating biologics early in their disease course were generally older at diagnosis but younger at the time of biologic initiation compared to patients initiating biologics later in their disease course.

Factors Associated with Delays in Initiating Biologic Therapy in Patients with Inflammatory Bowel Disease.

Expeditious initiation of biologic therapy is important in patients with inflammatory bowel disease (IBD). However, initiation of biologics in the outpatient setting may be delayed by various clinical, social, and financial variables. To evaluate the delay in initiation of an advanced therapy in IBD and to identify factors that contributed to this delay. This was a multi-center retrospective study. Outpatients who were initiated on a biologic therapy from 3/1/2019 to 9/30/20 were eligible for the study. Univariate and multivariate linear regression analyses were performed to identify variables associated with a delay in biologic treatment initiation. Delay was defined as the days from decision date (prescription placement) to first infusion or delivery of medication. In total 411 patients (Crohn's disease, n = 276; ulcerative colitis, n = 129) were included in the analysis. The median [interquartile range-(IQR)] delay for all drugs was 20 [12-37] days (infliximab, 19 [13-33] days; adalimumab, 10 [5-26] days; vedolizumab, 21 [14-42] days; and ustekinumab, 21 [14-42] days). Multivariate linear regression analysis identified that the most important variables associated with delays in biologic treatment initiation was self-identification as Black, longer distance from treatment site, and lack of initial insurance coverage approval. There may be a significant delay in biologic treatment initiation in patients with IBD. The most important variables associated with this delay included self-identification as Black, longer distance from site, and lack of initial insurance coverage approval.

Use of bimekizumab to treat palmoplantar psoriasis in a patient receiving treatment for disseminated tuberculosis: A Case Report.

Due to their inherent role in immunomodulation, concerns have long existed about the use of biologic therapies in patients with active tuberculosis. Most guidelines currently list active tuberculosis as an absolute contraindication to the use of immunomodulatory therapies. Contrary to this, we present a case of a patient with active, disseminated tuberculosis, safely treated with the IL-17 inhibitor bimekizumab.

Frequency of use and annual costs of biological therapy for psoriasis in Colombia in 2019.

Evidence describing the types and annual costs of biological treatments for psoriasis in Latin America is scarce. This study aimed to estimate the frequency of use and costs of biologic therapy for psoriasis in Colombia in 2019. This secondary data analysis uses the International Classification of Diseases terms associated with psoriasis, excluding those related to psoriatic arthritis, based on data from the registry of the Colombian Ministry of Health. We estimated the prevalence of psoriasis per 100,000 inhabitants; then, we retrieved the frequency of use of biologic therapy in patients with psoriasis and estimated the cost per year of each and overall therapies in 2019 in US dollars (USD). There were 100,823 patients with psoriasis in Colombia in 2019, which amounts to a prevalence of 0.2% in the general population. Of those patients, 4.9% received biologic therapy, most frequently males (60%). The most commonly used biological therapies for psoriasis in Colombia in 2019 were ustekinumab (35.2%), with an annual cost per patient of $12,880 USD; adalimumab (26%), with a yearly cost per patient of $7130 USD; and secukinumab (19.8%), with an annual cost per patient of $6825 USD. This is the first study to describe the use and cost of biological therapy for psoriasis in Colombia. It provides valuable cost-awareness information for the Colombian health system.

Outcomes of biological therapy in patients with severe asthma with chronic rhinosinusitis in Saudi Arabia: patients with nasal polyps versus those without nasal polyps

BackgroundThis study’s purposes were to evaluate the impact of biological therapies on outcomes in patients with severe asthma (SA) and chronic rhinosinusitis (CRS) and to compare these effects among those with NP (CRSwNP) versus those without NP (CRSsNP) in the “real-world” setting in Saudi Arabian patients.MethodsFrom March to September 2022, a retrospective observational cohort study was undertaken at the severe asthma clinics of the Armed Forces Hospital—Southern Region (AFHSR) and King Khalid University Hospital, Abha, Saudi Arabia, to delineate the effects of dupilumab therapy. Outcomes were assessed, including clinical outcomes, FEV1, and laboratory findings before and one year after dupilumab. Post-therapy effects were compared between CRSwNP and CRSsNP.ResultsFifty subjects were enrolled, with a mean age of 46.56. There were 27 (54%) females and 23(46%) males. Significant improvements in clinical parameters (frequency of asthma exacerbations and hospitalizations, the use of OCs, anosmia, SNOTT-22, and the ACT), FEV1, and laboratory ones (serum IgE and eosinophilic count) were observed 6 and 12 months after using dupilumab (p < 0.001), respectively. However, after 12 months of dupilumab therapy, there were no significant differences between those with and without NP with regards to clinical (anosmia, ACT, and OCs use), laboratory (eosinophilic count, serum IgE level) parameters, and FEV1%.ConclusionsPatients with CRS experienced significant improvements in clinical, FEV1, and laboratory outcomes after dupilumab therapy. However, these improvements were not maintained when comparing CRSwNP with CRSsNP. There were no significant differences between those with and without NP regarding ACT and OCs use or laboratory (eosinophilic count, serum IgE level) parameters. Further prospective multicenter studies are warranted.

Effectiveness of Biologic Therapy in Controlling Inflammation and Achieving Disease Remission in Patients with Rheumatoid Arthritis: A Systematic Review

Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disorder characterized by joint pain, swelling, and potential systemic complications. The usefulness of biological treatments in reducing inflammation and helping RA patients achieve clinical remission is assessed in this systematic narrative review. Using PubMed, Scopus, and Google Scholar, a thorough literature search was carried out with an emphasis on research published in the last five years. The inclusion criteria were English-language human subject research that contributed significantly to our understanding of biological therapies for RA. Despite concerns over long-term drug withdrawal, TNF-alpha inhibitors, including certolizumab, adalimumab, and infliximab, have shown considerable effectiveness in lowering disease activity and inducing remission. Tocilizumab and other IL inhibitors have shown strong anti-inflammatory properties and increased rates of medication retention. Certain patient profiles have shown success with other biologics, such as rituximab and abatacept, especially those who have not responded to previous therapies. Empirical evidence demonstrates that tofacitinib, a JAK inhibitor, is just as effective as conventional biologics. The study emphasizes how important it is to create individualized treatment programs depending on the medical history and response to the condition. Even with encouraging findings, improving RA care requires ongoing observation of safety profiles and long-term effects. This study offers a thorough synthesis of the available data to help physicians choose the best biologic therapy for patients with RA.

Efficacy of benralizumab in severe eosinophilic asthma: results of a real clinical practice prospective study BEST in Russia

The study of the efficacy of biological therapy in patients with severe bronchial asthma in real world settings is a relevant task since observational research programs allow answering questions that fall out of focus with a strict selection of patients in RCT. Multicenter studies are prioritized because they allow combining and systematizing additional previously undescribed data in a wider population.The aim of the BEST study (Real World Evidence of Benralizumab in Eosinophilic Severe AsThma in Russia) was to confirm the clinical effectiveness of benralizumab regarding change of disease control and quality of life (QoL) level associated with respiratory status in patients with eosinophilic phenotype of uncontrolled severe asthma in real clinical practice in Russia.Methods. An open-label non-randomised multicenter study was conducted involving 59 adult patients with severe eosinophilic asthma. Benralizumab was prescribed according to indications used in routine practice in addition to maintenance therapy. The duration of follow-up was 56 weeks. Disease control level was assessed using the Asthma Control Questionnaire-5 (ACQ-5), and QoL associated with respiratory status was assessed using the St. George’s Respiratory Questionnaire (SGRQ). Patients’ Global Impression of Change (PGIC) and Patients’ Global Impression of Severity (PGIS) were used for subjective assessments of the well-being of patients. The frequency of exacerbations, usage of systemic corticosteroids (SCS), and functional parameters were also evaluated.Results. The use of benralizumab led to a clinically significant improvement in ACQ-5 and SGRQ scores, a significant decrease in the frequency of exacerbations and a significant increase in pre- and post-bronchodilation FEV1 and FVC. There was an improvement in the well-being of patients according to the PGIC and PGIS scales. The SCS dose did not change. The therapeutic effect of benralizumab occurred quickly and persisted throughout the whole study, demonstrating the most significant changes in effectiveness values by the 56th week of treatment.Conclusion. The use of benralizumab in real clinical practice significantly improved the control of severe eosinophilic asthma and QoL of patients and was associated with a favorable safety profile.

P014 Treatment response in psoriatic arthritis: a comparison between the disease activity scores psoriatic arthritis response criteria and disease activity score-28

Abstract Background/Aims Despite NICE guidelines recommending the use of the PsA response criteria (PsARC), to assess response to biologic therapies in patients with psoriatic arthritis (PsA), some clinicians use the Disease Activity Score (DAS-28) criteria, developed for rheumatoid arthritis. However, whether the two scores are interchangeable and/or capture similar information has not yet been explored. Here, we investigate the differences and overlap between these two disease activity scores, in identifying good/poor responders, in PsA. Methods Utilising treatment response data from the OUTPASS cohort; a UK based multi-centre observational study, PsA patients assessed with PsARC and DAS-28 scores were calculated at baseline (pre-treatment), 3-months and 6-months (3M),(6M), following treatment, where available. EULAR good/moderate response was combined and compared with PsARC responder status. Subgroup analysis of patients with both PsARC and DAS-28 scores at either 3M or 6M, were tested for agreement using the Cohen’s Kappa test. Statistical tests were also used, as appropriate, to investigate differences between the baseline subcomponents, in the observed concordant and discordant data. Results Response data from 418 patients was available. An average of 76% were classified as responders according to PsARC, and 80% according to the EULAR response criteria, for both 3M and 6M, with 12% discordance. A subgroup analysis of 218 patients assessed with both scores, (up to 6M), revealed 17.9% responder discordance between PSARC and DAS-28, and 82.1% concordance. The Cohen’s Kappa test defined the assessment of responder/non-responder outcome, as an ‘almost perfect agreement’ (0.82) between the two criteria. Further statistical analyses, of baseline subcomponents, of both response criteria, between these discordant/concordant subsets, showed no significant difference, except for PsARC Physician’s and Patient’s Global Assessments (PhGA), (PGA), (P = 0.01, P = 0.02, Table 1). Conclusion PsARC and EULAR response criteria show ‘almost perfect agreement’, strongly supporting clinical use for either score. PhGA, (not a subcomponent of DAS-28) and PsARC PGA were the only significantly different (P &amp;lt; 0.05) components between the discordant and concordant groups, highlighting the importance of considering psychosocial factors which may affect pain tolerance and treatment response. Comparative analyses with other widely used scores, such as DAPSA, would also be informative for future work. Disclosure K. Patel: Grants/research support; This project has received support from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101007757 (HIPPOCRATES), the JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA, the results reflect only the author's view and the JU are not responsible for any use that may be made of the information it contains.. N. Nair: None. M. Jani: None. H. Chinoy: Consultancies; H.C. has received Consulting for PTC Therapeutics. Member of speakers’ bureau; H.C. has received fees as a speaker for GSK, UCB. Other; H.C. for Advisory Board member for Astra Zeneca, Pfizer, Argenx, Galapagos; Data and Science Monitoring Board chair for Horizon Therapeutics. J. Bluett: Grants/research support; J.B. has received a research grant award from Pfizer and travel/conference fees from UCB, Fresenius Kabi, Pfizer and Eli Lilly. (Pfizer: WI239449). A. Barton: Grants/research support; A.B. has received research grants from Bristol Myers Squibb and Pfizer and speaker fees from Galapagos.. P. Curry: None.

Effectiveness and safety of biological therapy in patients with severe asthma in a real clinical practice

To assess effectiveness and safety of biological therapy in patients with severe asthma during 5 yr follow-up. We recruited 129 adult outpatients (29% males) aged 18-81 yrs with severe asthma were followed up during 5 yrs and were examined for every 3-6 months. Eighty five patients were treated by conventional therapy (ICS/LABA ± tiotropium, montelukast, OCS) only and 44 pts additionally received biologicals (оmalizumab - 9 pts, мepolizumab - 8 pts, benralizumab - 11 pts, dupilumab - 16 pts). Pulmonary function tests were measured by dry spirometer (2120, Vitalograph Ltd., UK). Eosinophil count in blood was assessed by automatic haemoanalyser. Fraction of exhaled nitric oxide was measured by a chemiluminescence analyzer (LR4100; Logan Research, UK). Asthma control and quality of life were assessed by using Russian versions of ACQ-5 and SGRQ. The use of biologicals led to a more significant reduction of exacerbations and OCS use, improvement of lung function, asthma control and quality of life, decrease of eosinophil and fraction of exhaled nitric oxide than conventional therapy of severe asthma (p<0.05). Systemic side effects were not registered, frequency of local adverse reactions (edema, hyperemia and itching at injection site) was 14%. Long-term use of biologicals added to conventional therapy in patients with severe asthma is characterized by high effectiveness and favorable safety profile.

Biologic therapy in patients with severe NSAID-exacerbated respiratory disease and previous aspirin desensitization : Results of a multicentric study

Chronic rhinosinusitis with nasal polyps (CRSwNP) is atype‑2 inflammatory disease of the upper airways, with severe impairment of quality of life. Persons affected by NSAID-exacerbated respiratory disease (NERD) usually present with highly dynamic recurrence of polyps and disease despite prior treatment with sinus surgeries, oral corticosteroids, and aspirin desensitization (ATAD). Biologic therapy has fundamentally changed the choice of therapeutic concept; however, limited data exist on subgroups such as NERD patients. The aim of the current article is to report on amulticenter retrospective study on add-on therapy with dupilumab, omalizumab, and mepolizumab in patients with NERD. This is aretrospective cohort study of patients (NERD+, status after ATAD) in three reference centers in Germany (Munich, Mainz, Berlin). Subjective and objective parameters were collected at 4, 8, and 12months after biologic therapy initiation in accordance with current EPOS/EUFOREA (European Position Paper on Rhinosinusitis and Nasal Polyps/European Forum for Research and Education in Allergy and Airway Diseases) guidelines. Biologic agents were chosen depending on availability and patient characteristics. Treatment was commenced in 122patients meeting the criteria for CRSwNP and NERD. The endoscopic polyp score, SNOT-22 questionnaire score, visual analogue scoring of total symptoms/severity of disease, and sense of smell (psychophysical testing with Sniffin'Sticks/Brief Smell Identification Test, B‑SIT; Sensonics, Inc., Haddon Heights, NJ, USA) improved significantly after 4 and 12months of add-on therapy (p < 0.0001). All three biologic agents significantly improved one or more disease parameter. Adverse events were not life threatening but led to change of biologic agent in 4cases. Patients rated biologic therapy significantly better than ATAD, with improved long-term disease control. Add-on biologic therapy is effective, safe, and widely accepted among CRSwNP + NERD patients. Future studies might allow for personalized algorithms with sequential surgery, ATAD, and/or biologic therapy.

Response Types and Factors Associated with Response Types to Biologic Therapies in Patients with Moderate-to-Severe Plaque Psoriasis from Two Randomized Clinical Trials.

This study aimed to understand treatment response dynamics, including factors associated with favorable response, among patients with moderate-to-severe psoriasis who received guselkumab, adalimumab, or secukinumab. These post hoc analyses used data from the phaseIII clinical trials ECLIPSE and VOYAGE1, which were conducted between September 2021 and November 2022. On the basis of absolute Psoriasis Area and Severity Index (aPASI) scores, patients were divided into short-term response types (SRT1-6, based on week20-48 response) and long-term response types (LRT1-4, based on week52-252 response). Response types(RTs) were based on aPASI cutoffs deemed clinically relevant by the investigators; SRT1/LRT1 were the most favorable response types. Baseline characteristics were compared across RTs, and logistic regression analyses established factors associated with SRT1/LRT1. Overall, 1045, 662, and 272 patients were included in the ECLIPSE short-term, VOYAGE1 short-term, and VOYAGE1 long-term analyses, respectively. Mean age, body mass index (BMI), baseline aPASI score, and body surface area were lower in SRT1 than SRT6. In VOYAGE1, adalimumab treatment, high BMI, and current/former smoking status resulted in less favorable responses. In the VOYAGE1 long-term analysis, patients in LRT4had the highest baseline aPASI score, were older, and were more often obese compared with other LRT groups. Regression analyses showed that SRT1 (both treatments) in VOYAGE1 and ECLIPSE, and LRT1 (guselkumab group) in the VOYAGE1 long-term analysis, were associated with week16 aPASI response. In VOYAGE1, SRT1 was associated with psoriasis duration and smoking status. Early treatment response and baseline characteristics, including smoking, psoriasis duration, and obesity, may be associated with longer-term response to biologics. ECLIPSE: NCT03090100, VOYAGE1: NCT02207231.

The use of biologic therapy in patients with ankylosing spondylitis and coxitis: dynamics of clinical and laboratory parameters and structural progression

Hip joint inflammation (coxitis) occurs in almost half of patients with ankylosing spondylitis (AS) and often leads to early disability. A therapy for this condition has not yet been developed, although it is one of the indications for the initiation of biologic therapy in national recommendations. The review presents data from recent clinical trials on the use of biologics, focusing on the Russian national multicenter study of GO-COX in patients with AS with coxitis.Tumour necrosis factor-α inhibitors have been shown to be effective against inflammatory affection of the hip joint in patients with AS, and their administration over a two-year period inhibits the progression of coxitis.

Evaluation of Therapeutic Response Under Biologic Therapy in Patients with Rheumatoid Arthritis

Biotherapy has revolutionized the therapeutic management of rheumatoid arthritis (RA). The objective of the study was to evaluate and compare the efficacy and tolerance of biological disease modifying antirheumatic drugs (bDMARDs) and conventional disease modifying antirheumatic drugs ( cDMARDs) used in RA.&#x0D; It was a retrospective study covering 13 years at the level of the immunology unit of the UHU Hassiba Ben Bouali Blida and functional rehabilitation service of the CHU Frantz Fanon Blida. We identified 1866 records of patients with RA, 75 receiving biotherapy and 71 receiving conventional treatment. The therapeutic response was evaluated by the DAS 28-ESR (disease activity score based on erythrocyte sedimentation rate) and interpreted according to the EULAR (European league against rheumatism) judgements criteria.&#x0D; A female predominance of 83%, the average age of RA patients was 49.3 ±13.42 years, the mean starting DAS28-ESR was 5.625± 1.4. 84% of patients initially received MTX (methotrexate) on the front line, the decrease in DAS28-ESR was non- significant, with patients exhibiting intolerance (41%), and (45%) ineffectiveness. The introduction of biotherapy mainly Actemra allowed a decrease of DAS28-ESR of - 1.842±0.3812, a significant decrease according to the criteria of the EULAR. Humira had an adverse efficacy and tolerance profile (including the occurrence of severe adverse effects (AEs)).&#x0D; In conclusion, biotherapy is more effective than conventional treatments, while in terms of tolerance data are insufficient to make a judgment on it.&#x0D; Keywords: Rheumatoid arthritis – Biotherapy.

Dose Tapering and Discontinuation of Biologic DMARDs in Axial Spondyloarthritis: A Narrative Review (2023 SPARTAN Annual Meeting Proceedings).

Limited data is available for tapering or discontinuation of biologic therapy in patients with axSpA who are in disease remission. The current review concentrates on published studies regarding dose tapering or withdrawal of biologics in axSpA. Recent evidence in light of randomized controlled trials suggests that tapering of b-DMARDs is a feasible strategy to maintain remission or low disease activity in axSpA patients. TNF inhibitors were the studied biologics in most of these trials. The disease flare rates were comparable to those maintained on standard dose in most of these studies, although with variable tapering strategies and follow-up. Additionally, the duration of disease in remission prior to tapering, studied primary outcome, and flare definitions were heterogeneous. Female sex, HLA-B*27 negativity, high physician global score, and high CRP were negative predictors of successful tapering, but not consistently reported in all the trials. Although designed to address efficacy, there were no safety concerns with b-DMARD tapering. Withdrawal or complete discontinuation of biologics met with increased risk of flares compared to standard dosing. Tapering of TNF inhibitors may be feasible in certain axSpA patients with an acceptable disease state; however, discontinuation is not currently recommended owing to increased risk of flare. Future studies with axSpA patients with longer remission duration prior to taper and different doses and types of b-DMARDs may provide more guidance.