Avaliação tomográfica das dimensões verticais dos tecidos periodontais supracrestais em dentes anteriores da maxila / Tomographic evaluation of the vertical dimensions of periodontal supracrestal tissues in maxillary anterior teeth

O objetivo do presente estudo foi avaliar em tomografias computadorizadas as dimensões dos tecidos periodontais supracrestais (TPSC). Cem pacientes, 600 dentes anteriores da maxila (200 incisivos centrais, 200 incisivos laterais e 200 caninos), foram avaliados. A distância média da margem gengival até a crista óssea alveolar (COA) foi de 3.25mm (95% IC: 3.20-3.30), enquanto que da junção cemento-esmalte até a COA foi de 1.77mm (95% IC: 1.72-182mm). As medidas foram significativamente diferentes entre os grupos de dentes (ANOVA, p < 0.001). A tomografia, pode representar uma importante ferramenta para a avaliação das dimensões dos TPSC.

The aim of this study was to evaluate the dimensions of the supracrestal periodontal tissues (SPT) on tomographic scans. One hundred patients, 600 maxillary anterior teeth (200 central incisors, 200 lateral incisors and 200 canines), were evaluated. The average distance from the gingival margin to the alveolar bone crest (ABC) was 3.25mm (95% CI: 3.20-3.30), while the distance from the cemento-enamel junction to ABC was 1.77mm (95% CI: 1.72-182mm). The measurements were significantly different between the tooth groups (ANOVA, p < 0.001). When properly indicated, tomography can be an important tool for assessing the dimensions of TPSCs on a case-by-case basis.

Temporal and regional variation in the use of biologic and targeted synthetic DMARDs for rheumatoid arthritis: a nationwide cohort study.

OBJECTIVE: To evaluate temporal and regional variation in biologic and targeted synthetic DMARD (b/tsDMARD) initiation for rheumatoid arthritis (RA) in England and Wales. METHODS: An observational cohort study was conducted for people with RA enrolled in the National Early Inflammatory Arthritis Audit (NEIAA) between May 2018 and April 2022 who had 12-month follow-up data. Temporal trends in escalation to b/tsDMARDs within 12 months of initial rheumatology assessment were explored, including comparisons before and after publication (July 2021) of national guidelines that lowered the threshold for b/tsDMARD initiation to include moderate-severity RA. Case-mix-adjusted, mixed-effects regression was used to evaluate regional and hospital-level variation in b/tsDMARD initiation. RESULTS: Of 6,098 RA patients with available follow-up, 508 (8.3%) initiated b/tsDMARDs within 12 months of initial assessment. b/tsDMARD escalation increased marginally towards the end of the study period (9.2% in May 2021/22); however, no significant differences were evident after guidelines were published permitting b/tsDMARDs for moderate-severity RA. The proportion of individuals escalated to b/tsDMARDs varied considerably between regions, ranging from 5.1% in Wales to 10.7% in North-West England. Following case-mix adjustment, the intraclass correlation (ICC) for hospitals within regions was 0.17, compared with a between-region ICC of 0.0, suggesting that the observable regional variation reflected hospital-level differences rather than systematic differences between regions themselves. CONCLUSION: There is marked variation in escalation to b/tsDMARDs for people newly-diagnosed with RA throughout England and Wales, despite a universal healthcare system. These disparities must be addressed if we are to deliver equitable access to b/tsDMARDs, regardless of geography.

Long-Term Outcomes of Pediatric Pars Planitis: Retrospective Cohort from a Single Tertiary Center in Turkey.

PURPOSE: To retrospectively analyze long-term outcomes of pediatric pars planitis (PP). METHODS: PP was defined as vitreal inflammation with snowbank or snowball formation in the absence of a related disease. Eighty-five eyes of 44 patients were included in this study. Demographic and clinical characteristics were obtained from medical records. RESULTS: Approximately 70% of the patients were males; the mean patient age was 10.4 ± 3.6 years at presentation, and the mean follow-up time was 42.8 ± 27.9 months. At presentation, the mean best corrected visual acuity (BCVA, logMAR) was 0.17 ± 0.27 in the right eyes and 0.27 ± 0.33 in the left eyes. Common symptoms included blurry vision (29 eyes, 65%), redness (17, 38%), pain (8, 18%), and floaters (5, 11%). Sight-threatening complications included optic disc edema/hyperemia (26, 30%), cataracts (16, 18%), macular edema (16, 18%), and glaucoma (15, 17%). All 38 patients who initially required systemic treatment received corticosteroids. During the follow-up, 24 patients were treated with azathioprine, 20 with methotrexate, 11 with cyclosporine, 20 with adalimumab, and 8 with infliximab. At the final examination, the mean BCVA of the right and left eyes improved significantly (0.08 ± 0.23 and 0.06 ± 0.17, p = 0.006 and p < 0.001, respectively). The severities of vitritis, anterior chamber inflammation, snowbank/snowball formation, and endotheliitis decreased (all p < 0.001). Thirty-one patients remained on systemic treatment, with only four patients still receiving corticosteroids. No life-threatening adverse effects were reported. CONCLUSION: Despite pediatric PP's mild course, severe vision-threatening complications can occur. Immunomodulatory or biologic agents are important for controlling inflammation and tapering corticosteroids. Further research could enhance understanding of optimal treatments.

Real-world effectiveness of dupilumab in a European cohort of CRSwNP (CHRINOSOR).

BACKGROUND: Pivotal studies with dupilumab demonstrated clinically relevant improvements in nasal polyp score (NPS), symptom and quality of life scores in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). OBJECTIVE: We evaluated the effectiveness of dupilumab in a large-scale CRSwNP cohort from 6 European tertiary care centres. METHODOLOGY: NPS, SinoNasal Outcome Test (SNOT)-22 score, visual analogue scale (VAS) for total sinus symptoms, loss of smell (LoS) and nasal blockage (NB), and Asthma Control Test (ACT) score were collected from hospital records and assessed at baseline, 24 and 52 weeks of treatment of dupilumab in CRSwNP patients. Treatment effectiveness was evaluated in relation to demographic and lifestyle factors, sinus surgery history, presence of comorbidities and blood eosinophil counts (BEC). Treatment response was evaluated according to EUFOREA 2021 criteria. RESULTS: All patient outcomes improved at 24 and 52 weeks of treatment compared to baseline. Dupilumab showed effectiveness independent of age, sex, body mass index, smoking status, prior sinus surgery, presence of asthma, NSAID exacerbated respiratory disease (NERD), allergy or baseline BEC. 92.5% and 94.4% showed an improvement in at least 1 EUFOREA criterion at 24 and 52 weeks respectively. 54.4% and 68.2% reached all 4 of the more stringent EUFOREA criteria at 24 and 52 weeks respectively. CONCLUSIONS: Real-world evaluation of dupilumab effectiveness demonstrates a robust and sustained response in at least two thirds of patients at 52 weeks of treatment. Favourable treatment response was independent of the number of sinus surgery procedures, major comorbidities or baseline systemic levels of type 2 inflammation.

Patent Claim Scope and Biosimilar Competition in the US and EU.

The US has found it hard to establish competition in the market for biologics, which are therapeutics derived from living cells. In the case of small-molecule drugs, the emergence of direct competition from generic drugs at the end of the exclusivity period has provided the impetus for price competition, leading to lower spending. In 2010, to spur competition in the biologics market, Congress created a simplified pathway for the US Food and Drug Administration (FDA) to approve comparable versions of biologic drugs called biosimilars. Biosimilar competition in the US has nonetheless remained weaker than in European peer countries. For example, as of August 2020, there were 52 biosimilars available in Germany, and only 15 in the US.1 An important contributor to this "biosimilar gap" has been the fact that biosimilars to biologic blockbusters such as adalimumab (Humira) and etanercept (Enbrel) were only (or will only become) commercially available in the US several years after receiving FDA approval, while they were available in Europe years earlier.2 Through the end of 2021, it took biosimilars a median of 301 days between receiving FDA approval and becoming available for use.3 In one recent study, the median length of time between when a biologic drug was approved and when its first biosimilar was made available to US patients was 21.5 years.4 This paucity of competition has contributed to high US spending on biologics. According to the Department of Health and Human Services, in 2022 41% of US drug expenditures was spent on biologics, which represented 16% of US prescriptions.5.

A rare case of disseminated amebiasis in a patient on biologic therapy for chronic rhinosinusitis.

KEY POINTS: Dupilumab targets Th2-associated inflammatory mediators to reduce disease burden in CRSwNP. While rare, potential sequelae include viral, helminth, and potentially amebic infections.

The Effects of Heat Therapy During Immobilization and Rehabilitation on Muscle Atrophy and Strength Loss at Return to Sports in Healthy Humans.

Background: Animal research suggests that repeated heat exposures may stimulate skeletal muscle protein synthesis and downregulate protein degradation. Hypothesis: Repeated heat exposures during ankle immobilization and rehabilitation would preserve human muscle strength and mass. Study Design: Controlled laboratory study. Methods: A total of 20 male participants (age, 33.6 ± 2.8 years; weight, 83.8 ± 9.2 kg; height, 182 ± 6 cm) underwent 4 weeks of supervised training, 2 weeks of single-lower leg immobilization, and 2 weeks of supervised rehabilitation before return to sports (RTS). Participants were split into 2 groups: (1) whole-body heat therapy (HEAT) and (2) sham treatment (SHAM) throughout the immobilization and rehabilitation periods. Measures of muscle strength (isometric and isokinetic), volume (magnetic resonance imaging and ultrasound), and muscle biopsies were obtained preimmobilization, postimmobilization, and at RTS. Results: Maximal isometric strength of the plantarflexors was lower at RTS compared with preimmobilization in SHAM (P = .027) but not HEAT (P = .301). Isokinetic strength during a fatigue test was higher at RTS compared with preimmobilization in HEAT (P = .039) but not SHAM (P = .245). Pennation angle and muscle thickness were lower at postimmobilization compared with preimmobilization only in SHAM (P≤ .027). Muscle cross-sectional area decreased in soleus and both gastrocnemius medialis and lateralis (all P≤ .035) in SHAM, but only in gastrocnemius medialis in HEAT. There was a large (d = 0.91) but not significant (P = .054) decrease in the ratio of phosphorylated/total nuclear factor-kappa B (NFκB) from preimmobilization to postimmobilization in HEAT only. There was an increase in phosphorylated fork head box O proteins (FoxO) only in HEAT (P = .034), suggesting a decrease in FoxO activity. Caspase 3 expression increased from preimmobilization to postimmobilization in SHAM only (P = .004). Conclusion: These results indicate that using heat therapy throughout immobilization and rehabilitation reduces skeletal muscle atrophy and maintains plantarflexor strength in healthy humans. Moreover, heat therapy may lead to the inactivation of the FoxO and NFκB signaling pathways involved in atrophy. Clinical Relevance: Repeated heat exposures should be considered a novel therapeutic intervention to counteract muscle atrophy during immobilization.

Neurosarcoidosis: Current Perspectives on Diagnosis, Management, and Future Directions.

Neurosarcoidosis, a manifestation of sarcoidosis affecting the central or peripheral nervous system, presents unique challenges in diagnosis and management. Neurosarcoidosis can manifest with a wide range of symptoms, including cranial neuropathies, seizures, meningitis, and cognitive impairments. The heterogeneity of presentations often leads to diagnostic delays and complications. Diagnosis relies on a combination of clinical features, neuroimaging, cerebrospinal fluid analysis, and evidence of systemic sarcoidosis. Recent advances in imaging techniques, including high-resolution MRI, positron emission tomography (PET) scans, and novel biomarkers, have improved diagnostic accuracy. However, distinguishing neurosarcoidosis from mimicking conditions such as multiple sclerosis remains challenging. Treatment typically begins with corticosteroids, often requiring long-term immunosuppression. Second-line agents such as methotrexate and mycophenolate mofetil are frequently used as steroid-sparing options. Biologic therapies, particularly Tumor necrosis factor-alpha (TNF-α) inhibitors like infliximab, have shown promise in refractory cases. The long-term management of neurosarcoidosis necessitates a multidisciplinary approach with regular monitoring of disease activity and treatment response. Despite advancements, significant knowledge gaps persist in understanding the etiology, pathophysiology, and optimal management of neurosarcoidosis. Future research directions include identifying specific biomarkers, developing targeted therapies, and exploring novel imaging techniques. The rarity and heterogeneity of neurosarcoidosis underscore the importance of multicenter studies and international collaborations to advance our understanding and improve patient outcomes. Emerging technologies and innovative therapeutic approaches offer promising avenues for enhancing diagnosis and treatment in the coming years.

Pyoderma Gangrenosum in an Ulcerative Colitis Patient on Vedolizumab.

Pyoderma gangrenosum is a rare neutrophilic dermatosis that presents as a tender, rapidly progressive ulcer with violaceous, undermined borders. Pathophysiology is multifactorial and has been suggested to involve neutrophil dysfunction, increased T-cell activation, and inflammatory mediator release, often in settings that are known to have autoimmune or genetic diseases. Some medications that modify the immune response have been described to trigger pyoderma gangrenosum. Vedolizumab is a monoclonal antibody used in the management of inflammatory bowel disease that has been shown to be effective in the treatment of pyoderma gangrenosum but, in some cases, has been shown to paradoxically induce pyoderma gangrenosum. Vedolizumab causes gut-selective inhibition of lymphocyte migration, which may lead to the activation of lymphocytes in other organ systems, such as the skin. In this report, we present a case of pyoderma gangrenosum in a patient treated with vedolizumab for ulcerative colitis and explore the possible mechanism behind vedolizumab-induced pyoderma gangrenosum.

GDF-15 levels in patients with polycystic ovary syndrome treated with metformin: a combined clinical and in silico pathway analysis.

Objective: Polycystic ovary syndrome (PCOS) is an endocrine disease characterized by metabolic, reproductive, and psychological manifestations. Growth and differentiation factor 15 (GDF-15) is a cytokine associated with metabolic and inflammatory disorders. Metformin is commonly used for the treatment of PCOS. We investigated the relationship between GDF-15 levels and PCOS, the effect of metformin on GDF-15 levels, and potential biologic pathways related to GDF-15. Subjects and methods: The study included 35 women with PCOS and 32 women without PCOS (controls). Both groups were compared in terms of GDF-15 levels. Additional analysis was conducted on samples from 22 women with PCOS who were treated with either metformin (n = 7) or placebo (n = 15), retrieved from a previous randomized, controlled trial. Levels of GDF-15 were measured using MILLIPLEX. The biologic pathways related to GDF-15 were evaluated using the databases STRING, SIGNOR, and Pathway Commons. The statistical analysis was conducted using the software SPSS. Results: Levels of GDF-15 were higher in the PCOS group compared with the non-PCOS group (p = 0.039). Among women with PCOS, GDF-15 levels were higher in those treated with metformin compared with placebo (p = 0.007). The proteins related to GDF-15 overlapped between the databases, and a significant interaction was found between GDF-15 and proteins related to PCOS and its complications, including those related to estrogen response, oxidative stress, ovarian infertility, interleukin (IL)-18, IL-4, the ratio of advanced glycation end products to their receptor (AGE/RAGE), leptin, transforming growth factor beta (TGF-ß), adipogenesis, and insulin. Conclusion: The findings of the present study suggest a relationship between GDF-15 and PCOS and a potential increase in GDF-15 levels with metformin treatment. An additional finding was that GDF-15 could be involved in biologic pathways related to PCOS complications.

Multiarterial Grafting in Redo CABG: Type of Arterial Conduit and Patient Sex Determine Benefit.

OBJECTIVE: To evaluate whether multiarterial grafting provides incremental benefit above single arterial grafting in isolated redo CABG. METHODS: From 1/1980 to 7/2020, 6559 adults underwent 6693 isolated CABG reoperations. Patients undergoing multiarterial grafting were propensity-score matched with those undergoing single arterial grafting, with or without additional vein grafts, yielding 2005 well-matched pairs. Endpoints were in-hospital postoperative complications, hospital mortality, and long-term mortality. Median follow-up was 10 years with 25% followed >17 years. Multivariable multiphase hazard modeling and nonparametric random survival forests for survival were used to identify patients for whom multiarterial grafting was most beneficial. RESULTS: Among propensity-matched patients, postoperative complications for multiarterial versus single arterial grafting were any reoperation, 50 (2.5%) versus 65 (3.2%); renal failure, 73 (3.6%) versus 55 (2.7%); stroke, 44 (2.2%) versus 38 (1.9%); and deep sternal infection, 36 (1.8%) versus 25 (1.2%). Hospital mortality was 1.7% (n=35) versus 2.8% (n=56) (P=.03). Comparing multiarterial to single arterial grafting, survival at 1 and 3 years was 95% versus 94% and 92% versus 88%, and at 5, 15, and 20 years, survival was 87%, 49%, and 31% versus 82%, 42%, and 25%. Better survival after multiarterial grafting was confined to males with 2 patent internal thoracic artery grafts (P<.0001). CONCLUSIONS: Redo CABG with multiarterial grafting can be performed with lower in-hospital mortality and similar major morbidity to single arterial grafting. It is associated with better long-term survival, particularly in males when 2 internal thoracic artery grafts are used.

Maternal, Fetal, and Labour Outcomes of Dupilumab Use for Atopic Dermatitis During Pregnancy: A Systematic Review.

Atopic dermatitis is a chronic complex inflammatory disease that significantly impacts maternal well-being and quality of life during pregnancy, warranting effective therapeutic interventions that prioritize maternal health and fetal safety. Dupilumab is approved for moderate-to-severe atopic dermatitis, but limited data exist regarding its safety during pregnancy. We conducted a systematic review to review and analyze maternal, fetal, and labour outcomes in patients receiving dupilumab for atopic dermatitis during pregnancy. Comprehensive searches were conducted using databases including OVID, Scopus, and Web of Science, covering studies published until May 2024. Our search yielded 285 studies, of which 13 met the eligibility criteria. These studies included 68 patients with 69 pregnancies, revealing 58 live births and 11 spontaneous abortions. Dupilumab therapy was administered continuously throughout pregnancy in 22.2% of cases, while 77.8% received intermittent treatment. Maternal atopic dermatitis outcomes showed significant improvement in disease severity. Most pregnancies (86.3%) progressed without complications. Labour-associated outcomes varied, with 82.4% of women undergoing vaginal deliveries. The majority of births occurred at full term (82.5%), with a mean gestational age of 38.4 weeks. Fetal outcomes demonstrated a normal birth weight in 92.3% of cases, with no reported congenital defects. Our review suggests that dupilumab use during pregnancy is associated with improvement of atopic dermatitis and low or minimal risk of major adverse outcomes in treated patients or their newborns. Prospective studies with long-term follow-up are warranted to confirm the safety of dupilumab in this population.

Bone-protective effects of neutralizing angiopoietin-like protein 4 monoclonal antibody in rheumatoid arthritis.

Despite recent advances, rheumatoid arthritis (RA) patients remain refractory to therapy. Dysregulated overproduction of angiopoietin-like protein 4 (ANGPTL4) is thought to contribute to the disease development. ANGPTL4 was initially identified as a regulator of lipid metabolism, which is hydrolyzed to N-terminal and C-terminal (cANGPTL4) fragments in vivo. cANGPTL4 is involved in several non-lipid-related processes, including angiogenesis and inflammation. This study revealed that the level of ANGPTL4 was markedly elevated in the sera and synovial tissues from patients with RA versus controls. The administration of a neutralizing antibody against cANGPTL4 (anti-cANGPTL4 Ab) resulted in the inhibition of inflammatory processes and bone loss in animal models of collagen-induced arthritis and adjuvant-induced arthritis (AIA). Transcriptomic and proteomic profiling of synovial tissues from an AIA model indicated that the anti-cANGPTL4 Ab inhibited fibroblast-like synoviocyte (FLS) immigration and inflammatory-induced osteoclastogenesis. Mechanistically, the anti-cANGPTL4 Ab has been shown to inhibit TNF-α-induced inflammatory cascades in RA-FLS through the sirtuin 1/nuclear factor-κB signaling pathway. Moreover, the anti-cANGPTL4 Ab was found to block FLS invasion- and immigration-induced osteoclast activation. Collectively, these findings identify ANGPTL4 as a prospective biomarker for the diagnosis of RA, and targeting cANGPTL4 should represent a potential therapeutic strategy.

Influence of Chitosan on the Viability of Encapsulated and Dehydrated Formulations of Vegetative Cells of Actinomycetes.

This study focuses on developing an encapsulated and dehydrated formulation of vegetative actinobacteria cells for an efficient application in sustainable agriculture, both as a fungicidal agent in crop protection and as a growth-stimulating agent in plants. Three strains of actinobacteria were used: one from a collection (Streptomyces sp.) and two natives to agricultural soil, which were identified as S3 and S6. Vegetative cells propagated in a specific liquid medium for mycelium production were encapsulated in various alginate-chitosan composites produced by extrusion. Optimal conditions for cell encapsulation were determined, and cell damage from air-drying at room temperature was evaluated. The fresh and dehydrated composites were characterized by porosity, functional groups, size and shape, and their ability to protect the immobilized vegetative cells' viability. Actinomycetes were immobilized in capsules of 2.1-2.7 mm diameter with a sphericity index ranging from 0.058 to 0.112. Encapsulation efficiency ranged from 50% to 88%, and cell viability after drying varied between 44% and 96%, depending on the composite type, strain, and airflow. Among the three immobilized and dried strains, S3 and S6 showed greater resistance to encapsulation and drying with a 4 L·min-1 airflow when immobilized in coated and core-shell composites. Encapsulation in alginate-chitosan matrices effectively protects vegetative actinobacteria cells during dehydration, maintaining their viability and functionality for agricultural applications.

Patients With Graft Tears Leaving the Tuberosity Covered Have Similar Functional Outcomes to Those With an Intact Graft After Superior Capsular Reconstruction.

BACKGROUND: Studies to date of superior capsular reconstruction (SCR) comparing outcomes of healed grafts versus torn grafts do not separate graft tears based on location of the tear, rather they combine and report all tears as a single group. PURPOSE/HYPOTHESIS: The purpose of this study was to correlate functional outcome with graft integrity and graft tear location after SCR with a dermal allograft. It was hypothesized that the functional outcomes of patients with an intact graft would be equivalent to those with graft tears leaving the tuberosity covered. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: Patients who underwent SCR with an acellular dermal allograft at a single institution were included. Pre- and postoperative American Shoulder and Elbow Surgeons (ASES), Oxford Shoulder Score, visual analog scale (VAS) for pain, and postoperative Single Assessment Numeric Evaluation (SANE) scores were recorded. A magnetic resonance imaging scan was performed postoperatively to assess graft integrity. RESULTS: A total of 39 patients met inclusion criteria. Mean age of patients was 60.4 ± 8.7 years; mean follow-up was 53.3 ± 25 months (range, 14-98 months). Magnetic resonance imaging performed at a mean of 17.5 months (range, 6-66 months) demonstrated an intact graft in 14 (36%); tear from the glenoid in 11 (28%), from midsubstance in 4 (10%), and from the tuberosity in 8 (21%); and complete graft absence in 2 (5%). Patients were divided into group 1 (intact graft), group 2 (tuberosity covered: tears from glenoid and midsubstance tears), and group 3 (tuberosity bare: tears from the tuberosity and dissolved or absent grafts). In group 1, there was significant improvement in ASES (37.9 to 88.5; P < .001), Oxford (25.2 to 46.2; P < .001), and VAS (6.8 to 0.9; P < .001). In group 2, there was significant improvement in ASES (32.2 to 86.1; P < .001), Oxford (23.4 to 44.2; P < .001), and VAS (7.3 to 1.3; P < .001). In group 3, there was no significant improvement in ASES (40.3 to 45.8; P = .50) or Oxford (33.5 to 31.4; P = .81), but there was a significant reduction in VAS (7.1 to 5.4; P = .03). There was no significant difference between group 1 and 2 in postoperative ASES (88.5 vs 86.1; P = .59), Oxford (46.2 vs 44.2; P = .07), VAS (0.9 vs 1.3, P = .42) and SANE (85.4 vs 83.2; P = .92) scores. However, group 3 had significantly lower ASES (45.8; P < .001), lower Oxford (31.4; P < .001), lower SANE (45.4; P < .001), and higher VAS (5.4; P < .001) scores than groups 1 and 2. There were no differences in outcomes based on sex (P = .72), previous surgery (P = .06), preoperative acromiohumeral distance (P = .57), and preoperative Goutallier stage of the supraspinatus (P = .16). CONCLUSION: Patients who underwent SCR with a dermal allograft and developed a graft tear leaving the tuberosity covered had equivalent functional outcomes to those with an intact graft.

Infliximab versus interferon-alpha in the treatment of Behçet's Syndrome: Clinical data from the BIO-BEHÇET'S randomised controlled trial.

OBJECTIVES: Whilst biologic therapy is used for Behçet's Syndrome of all subtypes refractory to first-line immunomodulation, there has been an absence of high-quality evidence-and no predictive biomarkers to optimally inform choice. BIO-BEHÇET'S was a randomised, controlled, head-to-head clinical trial comparing the two most frequently used biologics in active refractory Behçet's. METHODS: Bayesian-designed, pragmatic, standard of care, two-arm, parallel head-to-head trial at four UK centres. Patients with active disease randomised to infliximab or interferon-α2a, and received follow-up with symptom-directed examination at Weeks 12 and 24. Primary outcome was Behçet's Disease Activity Index (BDAI) at 12 weeks. Secondary outcomes included BDAI at 24 weeks and significant improvement in individual organ systems, including ocular symptoms, oral and genital ulcers, arthritis pain, quality of life, disease activity, and steroid use. Biomarkers were also investigated but are reported elsewhere. RESULTS: 79 patients were recruited. Both treatments were equally effective, with a mean difference of 0.13 in BDAI (80% CI: -0.19, 0.46). No significant differences were observed for secondary outcomes, though there were clinically significant within-group reductions for each over time. A modest steroid-sparing effect was observed, with complete cessation of steroids in 20% and 44% of those randomised to infliximab and interferon-α2a, respectively. There was a trend for minor benefit in favour of infliximab in terms of tolerability and persistence. CONCLUSION: In this first reported, high-quality, head-to-head trial of two biologics in Behçet's, both infliximab and interferon-α2a showed comparable short-term clinical efficacy and safety in refractory active disease of all subtypes. TRIAL REGISTRATION: EudraCT: 2014-005390-36; ISRCTN: ISRCTN49793874.