BACKGROUND: Many ulcerative colitis (UC) patients require the use of second-line agents after the failure of anti-TNF therapy. RESEARCH DESIGN AND METHODS: We conducted a multicenter, retrospective study including 683 chronically active, moderate-to-severe UC patients who failed first-line anti-TNFs. The rate of treatment persistence and colectomy-free survival was assessed up to 3 years after the initiation of second-line therapy. Predictors for colectomy and persistence were investigated. RESULTS: After the failure of the first-line anti-TNF, ustekinumab had superior persistence and colectomy-free survival rates compared to tofacitinib (p = 0.05; p = 0.001) and vedolizumab (p = 0.02; p = 0.05), but significant difference was only found in persistence rates in comparison with anti-TNFs (p < 0.001). Regardless of the number of prior anti-TNFs, significantly higher persistence (p = 0.05) and colectomy-free survival rates (p = 0.01) were observed over 2 years with ustekinumab than with vedolizumab or tofacitinib, whereas ustekinumab's superiority over tofacitinib seemed to disappear by the third year. Hypoalbuminaemia (p = 0.002) and shorter disease duration at second-line initiation (p = 0.03) increased, while concomitant immunomodulators (p = 0.05) reduced the risk for colectomy. Shorter disease duration (p = 0.01) and primary non-response to the previously used anti-TNF (p < 0.001) negatively influenced persistence with second-line non-TNF-targeted agents. CONCLUSION: After first-line anti-TNF failure, switching to a non-anti-TNF agent is worth considering in moderate-to-severe UC.

• Klíčová slova
• anti-TNF failure, biological therapy, inflammatory bowel diseases, sequential therapy, ulcerative colitis,
• MeSH
• chronická nemoc MeSH
• dospělí MeSH
• gastrointestinální látky * terapeutické užití   aplikace a dávkování   MeSH
• humanizované monoklonální protilátky terapeutické užití   aplikace a dávkování   MeSH
• kohortové studie MeSH
• kolektomie MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• neúspěšná terapie MeSH
• piperidiny terapeutické užití   aplikace a dávkování   MeSH
• pyrimidiny terapeutické užití   aplikace a dávkování   MeSH
• pyrrolidiny terapeutické užití   aplikace a dávkování   MeSH
• retrospektivní studie MeSH
• senioři MeSH
• stupeň závažnosti nemoci MeSH
• TNF-alfa * antagonisté a inhibitory   MeSH
• ulcerózní kolitida * farmakoterapie   chirurgie   MeSH
• ustekinumab terapeutické užití   aplikace a dávkování   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• srovnávací studie MeSH
• Názvy látek
• gastrointestinální látky * MeSH
• humanizované monoklonální protilátky MeSH
• piperidiny MeSH
• pyrimidiny MeSH
• pyrrolidiny MeSH
• TNF-alfa * MeSH
• tofacitinib MeSH Prohlížeč
• ustekinumab MeSH
• vedolizumab MeSH Prohlížeč

INTRODUCTION: Significant proportion of patients with diffuse large B-cell lymphoma (DLBCL) is refractory or relapse (R/R) after the treatment. The prognosis of this patient cohort remains poor. Novel strategies mainly based on immunotherapy and targeted agents are currently being studied. Glofitamab is novel T-cell-engaging bispecific antibody possessing a 2:1 structure with bivalent CD20 binding. Its safety and efficacy in R/R B-cell non-Hodgkin lymphoma including DLBCL were evaluated in phase I-II NP30179 trial. AREAS COVERED: The article summarizes the milestones and latest reports on glofitamab development in the field of B-cell lymphoma treatment. EXPERT OPINION: Recently, phase II part of the NP30179 study and several other reports were published proving glofitamab potential in R/R DLBCL patients. Based on the published data, glofitamab was approved by regulatory authorities worldwide for the monotherapy of R/R DLBCL in conventional time-limited manner. It is readily accessible in case of rapidly progressing disease, and it compares well with other novel treatment options. Its side effects are similar to those of other T-cell-engaging agents and can be mitigated by pretreatment with obinutuzumab or step-up dosing. Its safety profile with manageable toxicities heads the clinical development toward combination strategies and its use in earlier therapeutic phases.

• Klíčová slova
• Bispecific antibody, T-cell engager, diffuse large B-cell lymphoma, glofitamab, immunotherapy,
• MeSH
• difúzní velkobuněčný B-lymfom * farmakoterapie   patologie   MeSH
• lidé MeSH
• lokální recidiva nádoru farmakoterapie   MeSH
• protilátky bispecifické * škodlivé účinky   MeSH
• protinádorové látky * terapeutické užití   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH
• Názvy látek
• glofitamab MeSH Prohlížeč
• protilátky bispecifické * MeSH
• protinádorové látky * MeSH

BACKGROUND: Tralokinumab is a human monoclonal antibody targeting interleukin-13 that is approved for the treatment of moderate-severe atopic dermatitis. Studies analyzing the efficacy and safety of tralokinumab in a real-world setting are scarce. RESEARCH DESIGN AND METHODS: A European, multicentric, real-world, retrospective cohort study was defined to assess the effectiveness and safeness profile of tralokinumab, investigating the achievement of pre-specified treatment goals; and to detect potential differences in terms of effectiveness and safeness across some selected patient subcohorts. RESULTS: A total of 194 adult patients were included in this study. A significant improvement in physician-assessed disease severity was detected at each follow-up visit as compared with baseline and similar trend was observed for patient-reported outcomes and quality of life. No meaningful difference in effectiveness was found when considering patient age (<65 versus ≥65 years), neither dissecting patient cohort in dupilumab-naive vs dupilumab-treated subjects. Among tralokinumab-treated patients, 88% achieved at least one currently identified real-world therapeutic goal at week 16. CONCLUSIONS: This retrospective multicenter study confirmed the effectiveness and safeness of tralokinumab throughout 32 weeks of observation, showing the achievement of therapeutic goals identified in both trial and real-world settings in a large proportion of tralokinumab-treated patients.

• Klíčová slova
• Atopic dermatitis, IL-13 inhibitor, Treatment goals, eczema, tralokinumab,
• MeSH
• atopická dermatitida * diagnóza   farmakoterapie   MeSH
• cíle MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• kohortové studie MeSH
• kvalita života MeSH
• lidé MeSH
• monoklonální protilátky škodlivé účinky   MeSH
• retrospektivní studie MeSH
• senioři MeSH
• stupeň závažnosti nemoci MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• Názvy látek
• monoklonální protilátky MeSH
• tralokinumab MeSH Prohlížeč

INTRODUCTION: IgA nephropathy is the most common primary glomerulonephritis worldwide. Immune complexes, composed of galactose-deficient IgA1 and Gd-IgA1 autoantibodies, are deposited in the mesangial area of the glomeruli where they induce complement-mediated inflammation. This may result in the reduced kidney function, which can progress to end-stage kidney disease. Treatment options are very limited. Treatments which directly affect the formation of pathogenic Gd-IgA1 antibodies and anti-Gd-IgA1 antibody-containing immune complexes are needed. AREAS COVERED: This article reviews potential therapies, namely monoclonal antibodies, that may affect the main axis of pathogenesis of IgA nephropathy with a discussion of their potential impact on the outcome of IgAN. PubMed was used to perform the literature search, which included papers on "treatment of IgA nephropathy"combined with "biological therapy", or 'monoclonal antibodies, atacicept, sibeprenlimab, rituximab, felzartamab, narsoplimab, iptacopan' published up to 2023. EXPERT OPINION: The new treatment options are aimed at the immunopathogenesis of IgAN, including depletion or modulation of Gd-IgA1 producing B cells, plasma cells, alternate or lectin pathway of complement. Monoclonal antibodies may target both B cells and T cells and also the factors needed for their activation and survival, e.g. BAFF or APRIL.

• Klíčová slova
• IgA nephropathy, chronic kidney disease, felzartamab, monoclonal antibodies, narsoplimab, sibeprenlimab, treatment,
• MeSH
• galaktosa metabolismus   MeSH
• IgA nefropatie * farmakoterapie   MeSH
• imunoglobulin A metabolismus   MeSH
• imunokomplex MeSH
• lidé MeSH
• monoklonální protilátky terapeutické užití   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• přehledy MeSH
• Názvy látek
• galactosyl-deficient IgA1 MeSH Prohlížeč
• galaktosa MeSH
• imunoglobulin A MeSH
• imunokomplex MeSH
• monoklonální protilátky MeSH

Background: BI 695501 is an approved biosimilar to Humira® reference product (RP). Research design and methods: In this randomized Phase III trial (VOLTAIRE-PSO), patients with moderate-to-severe chronic plaque psoriasis received BI 695501 or adalimumab RP (24-week treatment). Primary efficacy endpoint: the proportion of patients with ≥75% reduction in Psoriasis Area and Severity Index (PASI 75) response at week 16 (±18% equivalence limits for two-sided 95% confidence interval between treatment groups). Safety, pharmacokinetics, and immunogenicity were also assessed. Results: Baseline characteristics were balanced between treated groups (BI 695501, n = 159; adalimumab RP, n = 158). PASI 75 response rates (full analysis set, n = 158; n = 157) were 68.2% (BI 695501) and 70.4% (adalimumab RP) at week 16 (95% CI: -14.4%, 8.7%), and 75.3% and 72.4%, at week 24, respectively. At week 24, 41.5% (BI 695501) and 44.9% (adalimumab RP) of treated patients had treatment-emergent adverse events (AEs), 3.1% and 4.4% had serious AEs, and 0.0% and 1.9% had AEs of special interest. Of treated patients, 75.3% (BI 695501) and 77.9% (adalimumab RP) were anti-drug antibody-positive. Conclusion: These data demonstrate equivalent efficacy and highly similar safety and immunogenicity between BI 695501 and adalimumab RP in patients with chronic plaque psoriasis. Study identifier: NCT02850965.

• Klíčová slova
• Adalimumab, BI 695501, biosimilar, equivalence, psoriasis,
• MeSH
• adalimumab škodlivé účinky   MeSH
• biosimilární léčivé přípravky * škodlivé účinky   MeSH
• dvojitá slepá metoda MeSH
• lidé MeSH
• psoriáza * farmakoterapie   MeSH
• stupeň závažnosti nemoci MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• adalimumab MeSH
• BI 695501 MeSH Prohlížeč
• biosimilární léčivé přípravky * MeSH

INTRODUCTION: Although new drug classes have significantly extended survival of patients with multiple myeloma, they continue to experience multiple relapses and/or become refractory to treatment. Therefore, novel therapies and treatment combinations with different mechanisms of action are needed to improve the outcomes of patients with relapsed/refractory multiple myeloma. AREAS COVERED: Here, the authors review the published data regarding the development and clinical investigation of isatuximab, a CD38 monoclonal antibody, for treatment of patients with relapsed/refractory multiple myeloma. The mechanisms of action, clinical efficacy, and safety of isatuximab treatment are summarized. EXPERT OPINION: Isatuximab is approved in combination with pomalidomide/dexamethasone for the treatment of adults with relapsed/refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Isatuximab displays a manageable safety profile, with infusion reactions being the most common adverse events. Isatuximab is currently being further evaluated in combination with other backbone regimens in relapsed/refractory and newly diagnosed multiple myeloma.

• Klíčová slova
• CD38, isatuximab, monoclonal antibody, multiple myeloma, relapsed/refractory,
• MeSH
• chemorezistence účinky léků   MeSH
• dospělí MeSH
• humanizované monoklonální protilátky terapeutické užití   MeSH
• lenalidomid terapeutické užití   MeSH
• lidé MeSH
• lokální recidiva nádoru farmakoterapie   patologie   MeSH
• mnohočetný myelom farmakoterapie   patologie   MeSH
• protinádorové látky imunologicky aktivní terapeutické užití   MeSH
• protokoly protinádorové kombinované chemoterapie terapeutické užití   MeSH
• recidiva MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• přehledy MeSH
• Názvy látek
• humanizované monoklonální protilátky MeSH
• isatuximab MeSH Prohlížeč
• lenalidomid MeSH
• protinádorové látky imunologicky aktivní MeSH

Objectives: To assess the role of short-term response to first anti-TNF in long-term prediction of disability.Methods: In nationwide registry ATTRA, we identified ankylosing spondylitis patients starting anti-TNF between 01/2003 and 12/2016. Full disability and work impairment (WI; WPAI questionnaire) were predicted via the Cox- and lagged-parameter mixed-effect regression.Results: 2,274 biologicals-naïve patients newly indicated to anti-TNF were prospectively followed (6,333 patient-years; median follow-up 1.9 years). Reaching BASDAI < 4 (77.4%) and ASDAS-CRP < 2.1 (61.1%) after 3 months of anti-TNF both decreased the risk of future disability by ≈2.5-fold. ASDAS-CRP < 2.1 predicted non-disability better than BASDAI < 4 & CRP < 5 mg/L (p = 0.032). BASDAI < 4 & CRP < 5 mg/L was comparable to BASDAI < 4 (p = 0.941) and to BASDAI change by >50% or by >2 points (p = 0.902). ASDAS-CRP change >1.1 and >2.0 both failed to predict non-disability. Once on anti-TNF therapy, the strongest predictor of WI was Pain (SF36). Yearly increase in indirect costs remains below €3,000 in those reaching ASDAS-CRP < 2.1.Conclusions: Low disease activity measured by ASDAS-CRP ≤ 2.1 should be used to measure the outcome of new anti-TNF therapy. Continuous WI could be decreased through pain management.

• Klíčová slova
• ASDAS, Ankylosing spondylitis, BASDAI, anti-TNF, disability, multivariate modeling, predictive power, work impairment,
• MeSH
• absentérství MeSH
• ankylózující spondylitida komplikace   diagnóza   farmakoterapie   epidemiologie   MeSH
• biologické přípravky terapeutické užití   MeSH
• časové faktory MeSH
• dospělí MeSH
• kohortové studie MeSH
• lidé středního věku MeSH
• lidé MeSH
• longitudinální studie MeSH
• postižení statistika a číselné údaje   MeSH
• posuzování pracovní neschopnosti MeSH
• prognóza MeSH
• průzkumy a dotazníky MeSH
• registrace statistika a číselné údaje   MeSH
• stupeň závažnosti nemoci MeSH
• TNF-alfa antagonisté a inhibitory   imunologie   MeSH
• výkonnost * účinky léků   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• pozorovací studie MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Česká republika epidemiologie   MeSH
• Názvy látek
• biologické přípravky MeSH
• TNF-alfa MeSH

Introduction: The expiry of patents for biologics has led to the introduction of biosimilars for the treatment of immune-mediated inflammatory diseases (IMIDs). These treatment alternatives may allow earlier and wider access to appropriate therapy for patients without increasing the economic burden on health-care systems. Prescription of biosimilars to treatment-naïve patients is well accepted; however, additional considerations must be taken into account when switching clinically stable patients from reference products to biosimilars. Area covered: We discuss the current considerations related to switching from reference products to biosimilars from a physician and patient perspective. We review the clinical data and real-life experience on switching patients with IMIDs, present the position of the relevant medical societies, and discuss the importance of patient-physician communication and need for shared decision-making. Expert opinion: The introduction of biosimilars provides an opportunity to expand access to treatment for patients with IMIDs across Europe and support the financial sustainability of health-care systems. We anticipate that as the real-world evidence base grows, confirming the results of clinical trials, there will be a corresponding increase in physician and patient acceptance, not only to initiating treatment with a biosimilar, but also to switching medication from a reference product to a biosimilar.

• Klíčová slova
• Biological therapy, biosimilar, immune-mediated inflammatory disease, switching,
• MeSH
• biosimilární léčivé přípravky terapeutické užití   MeSH
• lidé MeSH
• nemoci imunitního systému farmakoterapie   genetika   imunologie   MeSH
• randomizované kontrolované studie jako téma MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• přehledy MeSH
• Názvy látek
• biosimilární léčivé přípravky MeSH

BACKGROUND: CT-P13, the first biosimilar monoclonal antibody to infliximab (IFX), has previously been confirmed to be efficacious in inducing mucosal healing in ulcerative colitis (UC) patients. The aim of this study was to evaluate the efficacy of CT-P13 therapy in maintaining mucosal healing in UC. METHODS: CT-P13 trough levels, antibody positivity, serum inflammatory markers as CRP level, fecal calprotectin at weeks 14 and 54, concomitant steroid and azathioprine therapy at the time of induction therapy and at weeks 14 and 54, previous use of anti TNF drug and the need of dose intensification as possible predictive factors for mucosal healing at week 54 were evaluated in this prospective study. RESULTS: 61 patients had already completed the 54-week treatment period. Mucosal healing was shown in 65.5 % and 62.1 %, complete mucosal healing was present in 31% and 38 % at week 14 and 54, respectively. The median values of CRP, leukocytes, thrombocytes, and albumin showed significant difference between baseline and week 54. Serum antibody positivity was proved in 6.5 % and 19.7 % of cases at week 14 and 54, respectively. CONCLUSION: Our study confirmed the long-term efficacy of CT-P13 therapy on mucosal healing in UC.

• Klíčová slova
• CT-P13, Ulcerative colitis, infliximab biosimilar, long-term efficacy, mucosal healing,
• MeSH
• biosimilární léčivé přípravky terapeutické užití   MeSH
• dospělí MeSH
• gastrointestinální endoskopie MeSH
• gastrointestinální látky terapeutické užití   MeSH
• hojení ran účinky léků   MeSH
• indukce remise MeSH
• infliximab terapeutické užití   MeSH
• kohortové studie MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• monoklonální protilátky terapeutické užití   MeSH
• senioři MeSH
• střevní sliznice účinky léků   patologie   MeSH
• ulcerózní kolitida diagnóza   farmakoterapie   patologie   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• pozorovací studie MeSH
• práce podpořená grantem MeSH
• Názvy látek
• biosimilární léčivé přípravky MeSH
• CT-P13 MeSH Prohlížeč
• gastrointestinální látky MeSH
• infliximab MeSH
• monoklonální protilátky MeSH

INTRODUCTION: Treatment of systemic lupus erythematosus (SLE) represents a challenge due to variable disease manifestations, clinical course, and outcome. Long-term outcome in SLE remain unsatisfactory and a search for new therapeutic options is definitely warranted. Despite expectations, most clinical trials performed in SLE and lupus nephritis in the last decade did not reach primary outcome, and the only drug that has been licensed is belimumab. AREAS COVERED: Results of negative trials testing monoclonal antibodies and other biologic agents in SLE are briefly summarized. Reasons for the failure of the trials are listed and discussed. EXPERT OPINION: Future studies should recruit patients with similar organ involvement, better defined disease manifestations, higher activity, and similar severity. In addition to testing higher efficacy if given as add-on treatment to standard-of-care, the trials should be aimed at reducing dosing, or completely eliminating some parts of the current standard treatment, especially corticosteroids. Median follow-up of the patients should be longer. Moreover, specific biomarkers are needed to help to identify eligible patients and to better define response to treatment. An urgent unmet need is testing these new drugs in patients with severe SLE (including those refractory to current treatment).

• Klíčová slova
• SLE, biologic treatment, clinical trial, monoclonal antibodies, treatment,
• MeSH
• biologické faktory terapeutické užití   MeSH
• biologické přípravky terapeutické užití   MeSH
• humanizované monoklonální protilátky terapeutické užití   MeSH
• klinické zkoušky jako téma normy   statistika a číselné údaje   MeSH
• lidé MeSH
• monoklonální protilátky terapeutické užití   MeSH
• neúspěšná terapie MeSH
• systémový lupus erythematodes farmakoterapie   epidemiologie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• přehledy MeSH
• Názvy látek
• belimumab MeSH Prohlížeč
• biologické faktory MeSH
• biologické přípravky MeSH
• humanizované monoklonální protilátky MeSH
• monoklonální protilátky MeSH