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Abstract Introduction Certolizumab pegol (CZP) is an anti-tumor necrosis factor alpha (TNFα) approved for the treatment of moderate to severe plaque psoriasis (PSO). However, data on its real-world use is currently limited. The objective of this study was to describe the 1-year real-world effectiveness of CZP, its impact on health-related quality of life (HRQoL), and safety outcomes in patients with moderate to severe PSO in multi-country settings. Methods CIMREAL, a prospective, noninterventional study, was conducted across Europe and Canada from August 2019 to December 2022. Patients were followed for 1-year, receiving CZP 400 mg initial doses at weeks 0, 2, and 4, followed by CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg Q2W maintenance dosing. Effectiveness was assessed using the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety was also evaluated. Results Overall, 399 patients with moderate to severe PSO were included. Of these, 93.7% (374/399) and 77.9% (311/399) completed months 3 and 12, respectively. Mean age (± standard deviation) was 42.9 ± 13.5 years and body mass index was 28.5 ± 6.8 kg/m2, with the majority of patients being female (68.2%). At 12 months, CZP showed substantial effectiveness, achieving PASI 75 and PASI 90 response rates (≥ 75% and ≥ 90% improvement from baseline, respectively) of 77% and 56.5%, respectively. Patients with PASI score of ≤ 3 and ≤ 2 experienced improvement from 3 months (49.8% and 41.1%, respectively) to 12 months (82.0% and 75.3%, respectively). HRQoL considerably improved, with mean DLQI scores decreasing from 12.4 to 2.3 after 12 months of treatment, and the proportion of patients with DLQI 0/1 increased from 28.6% at 3 months to 59.4% at 12 months. The 1-year probability of persistence was approximately 85%. Overall, 30.6% of the patients experienced any adverse events and 9.3% had serious adverse events. Conclusion In routine clinical practice, CZP exhibited consistent effectiveness, positively impacting both skin psoriasis activity and HRQoL. The 1-year persistence of CZP was high, and no new safety signals were identified. Trial Registration Number ClinicalTrials.gov Identifier: NCT04053881 https://www.clinicaltrials.gov/study/NCT04053881 .

Abstract Introduction The purpose of this study is to explore treatment preferences and identify patient characteristics in young bio-naive adults with moderate to severe psoriasis in the Nordic countries (Norway, Finland, Sweden, and Denmark). Methods Patients were 18–45 years old and bio-naive but referred for biologic treatment of moderate to severe psoriasis. Patients were included at eight Nordic dermatology clinics. Patients with significant comorbidity or psoriatic arthritis were excluded. The Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) were assessed along with basic patient information. A semistructured interview guide was used in individual qualitative interviews, asking patients about their treatment preferences and reasons, disease journey, and disease management. The interviews were analyzed using thematic content analysis. Twenty-four patients sufficed to reach saturation in this qualitative study. Results The patient sample characteristics represented a qualitative variation in age, sex, symptoms, duration of disease, and country. We included a total of 12 male and 12 female patients. The mean age was 34 years (range 18–45 years), the mean age at diagnosis was 20 years (range 6–34 years), the mean ± standard deviation (SD) time since diagnosis was 13 ± 8 years, PASI was 9.5 ± 4.7, and DLQI was 15.2 ± 6.4. Interviews suggested that both the burden of disease as well as the burden of treatment influenced patient preferences regarding treatment attributes, hence getting alleviation from symptoms did not alone influence patient preferences. Time, effort, and inconvenience related to psoriasis treatments also influenced patient preferences. Conclusions This first in-depth, qualitative study in young bio-naive adults with psoriasis suggests that patient preferences are focusing not only on symptom relief but also on alleviating the burden of psoriasis treatment. Understanding the reasons for patient preferences and the perspectives of young adults is needed to guide individual shared decision-making in psoriasis management.

Abstract Introduction Certolizumab pegol (CZP) is an Fc-free, PEGylated, anti-tumour necrosis factor biologic. Safety and efficacy data for CZP over 3 years have been previously reported. We report 3-year quality of life (QoL) outcomes for patients treated with CZP, pooled from two phase 3 trials. Methods Adults with moderate-to-severe plaque psoriasis for ≥ 6 months were initially randomised 1:2:2 to double-blinded placebo every 2 weeks (Q2W), CZP 200 mg Q2W (loading dose of CZP 400 mg at weeks 0/2/4) or CZP 400 mg Q2W. All patients received open-label CZP (200 mg or 400 mg Q2W) from week 48. Dermatology Life Quality Index (DLQI), 36-Item Short Form Survey (SF-36), EuroQol 5-Dimensions 3-Level (EQ-5D-3L) and Work Productivity and Activity Impairment (WPAI) scores are reported as observed. Results At week 0, 100 patients were randomised to placebo, 186 to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. For CZP-randomised patients, 60.9% had a DLQI score of 0 or 1 by week 48. Both the physical and mental component scores of SF-36 also improved from baseline to week 48 (mean change from baseline: 4.4 and 5.4, respectively). The proportion of patients with a score of 1 in the EQ-5D-3L Pain/Discomfort dimension increased (week 0, 21.1%; week 48, 66.2%), and WPAI Presenteeism, Work Impairment, and Activity Impairment improved from baseline to week 48, with the strongest gains observed for Activity Impairment (week 0, 33.3% of time impaired; week 48, 6.7%). Across patient-reported outcomes, gains were sustained through week 144, with durable improvements observed regardless of sex, psoriatic arthritis status or prior exposure to biologics. Conclusion CZP treatment was associated with sustained and tangible improvements in health-related QoL (DLQI and SF-36), health status (EQ-5D-3L) and functional impairment at work and in other daily activities (WPAI). Trial Registration ClinicalTrials.gov NCT02326298 (CIMPASI-1) and NCT02326272 (CIMPASI-2). Video Abstract (MP4 110310 kb)

Introduction: Combination vaccines improve vaccine uptake and open the infant immunization space for additional vaccines. Hexavalent vaccines have been marketed since 2000. Infanrix hexa (combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine, DTPa-HBV-IPV/Hib, GSK) is longest on the market, providing 16 years post-marketing experience. Each DTPa-HBV-IPV/Hib vaccine component is licensed alone and/or in smaller combination vaccines. Programmatic considerations sometimes require an interchange between vaccines due to unavailability, program change or mixed schedules (when the number of required antigens differs across scheduled primary vaccination visits). Areas covered: Immunogenicity and safety data from 11 GSK-sponsored clinical trials support the interchangeability of DTPa-HBV-IPV/Hib within the same vaccines family, and use of DTPa-HBV-IPV/Hib in mixed primary vaccination schedules. Expert commentary: Data show acceptability of interchange of DTPa-HBV-IPV/Hib with other products within the same vaccines family and its use in mixed immunization schedules. This aligns with WHO recommendations that vaccines of the same family from the same manufacturer be used to complete the infant vaccination schedule. Interchangeability and suitability for use in mixed schedules is of interest for policy-makers/providers in the framework of vaccination recommendations as it provides flexibility. Given the complexity of larger combination vaccines, interchangeability or sequential use needs careful assessment.

The article discusses the use of Certolizumab pegol (CZP) for treating plaque psoriasis in women of childbearing potential, including pregnant and breastfeeding women. The study evaluated the effectiveness and safety of CZP in these populations over a one-year period, showing improvements in Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) outcomes. The data indicated that CZP provided effective psoriasis control with minimal fetal drug exposure during pregnancy and breastfeeding, supporting informed discussions between physicians and patients. The study acknowledges limitations in its exploratory nature and the need for further research in this area. [Extracted from the article]

This correction notice is for an article titled "Certolizumab Pegol for the Treatment of Plaque Psoriasis in Routine Clinical Practice: One-Year Results from the CIMREAL Study" published in Dermatology & Therapy. The correction replaces incorrect versions of Tables 1 and 2 with the correct versions. Table 1 provides information on demographics, baseline, and clinical characteristics of the study participants, while Table 2 presents an overview of adverse events. The original article has been corrected. [Extracted from the article]

Introduction: Certolizumab pegol (CZP) is an anti-tumor necrosis factor alpha (TNFα) approved for the treatment of moderate to severe plaque psoriasis (PSO). However, data on its real-world use is currently limited. The objective of this study was to describe the 1-year real-world effectiveness of CZP, its impact on health-related quality of life (HRQoL), and safety outcomes in patients with moderate to severe PSO in multi-country settings. Methods: CIMREAL, a prospective, noninterventional study, was conducted across Europe and Canada from August 2019 to December 2022. Patients were followed for 1-year, receiving CZP 400 mg initial doses at weeks 0, 2, and 4, followed by CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg Q2W maintenance dosing. Effectiveness was assessed using the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety was also evaluated. Results: Overall, 399 patients with moderate to severe PSO were included. Of these, 93.7% (374/399) and 77.9% (311/399) completed months 3 and 12, respectively. Mean age (± standard deviation) was 42.9 ± 13.5 years and body mass index was 28.5 ± 6.8 kg/m2, with the majority of patients being female (68.2%). At 12 months, CZP showed substantial effectiveness, achieving PASI 75 and PASI 90 response rates (≥ 75% and ≥ 90% improvement from baseline, respectively) of 77% and 56.5%, respectively. Patients with PASI score of ≤ 3 and ≤ 2 experienced improvement from 3 months (49.8% and 41.1%, respectively) to 12 months (82.0% and 75.3%, respectively). HRQoL considerably improved, with mean DLQI scores decreasing from 12.4 to 2.3 after 12 months of treatment, and the proportion of patients with DLQI 0/1 increased from 28.6% at 3 months to 59.4% at 12 months. The 1-year probability of persistence was approximately 85%. Overall, 30.6% of the patients experienced any adverse events and 9.3% had serious adverse events. Conclusion: In routine clinical practice, CZP exhibited consistent effectiveness, positively impacting both skin psoriasis activity and HRQoL. The 1-year persistence of CZP was high, and no new safety signals were identified. Trial Registration Number: ClinicalTrials.gov Identifier: NCT04053881 https://www.clinicaltrials.gov/study/NCT04053881. [ABSTRACT FROM AUTHOR]

The original article can be found online at https://doi.org/10.1007/s13555-022-00861-4. B Publisher Correction: Dermatol Ther (Heidelb) b https://doi.org/10.1007/s13555-022-00861-4 In the original publication, the supplementary material was incorrectly formatted prior to publication. [Extracted from the article]

Introduction: The purpose of this study is to explore treatment preferences and identify patient characteristics in young bio-naive adults with moderate to severe psoriasis in the Nordic countries (Norway, Finland, Sweden, and Denmark). Methods: Patients were 18–45 years old and bio-naive but referred for biologic treatment of moderate to severe psoriasis. Patients were included at eight Nordic dermatology clinics. Patients with significant comorbidity or psoriatic arthritis were excluded. The Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) were assessed along with basic patient information. A semistructured interview guide was used in individual qualitative interviews, asking patients about their treatment preferences and reasons, disease journey, and disease management. The interviews were analyzed using thematic content analysis. Twenty-four patients sufficed to reach saturation in this qualitative study. Results: The patient sample characteristics represented a qualitative variation in age, sex, symptoms, duration of disease, and country. We included a total of 12 male and 12 female patients. The mean age was 34 years (range 18–45 years), the mean age at diagnosis was 20 years (range 6–34 years), the mean ± standard deviation (SD) time since diagnosis was 13 ± 8 years, PASI was 9.5 ± 4.7, and DLQI was 15.2 ± 6.4. Interviews suggested that both the burden of disease as well as the burden of treatment influenced patient preferences regarding treatment attributes, hence getting alleviation from symptoms did not alone influence patient preferences. Time, effort, and inconvenience related to psoriasis treatments also influenced patient preferences. Conclusions: This first in-depth, qualitative study in young bio-naive adults with psoriasis suggests that patient preferences are focusing not only on symptom relief but also on alleviating the burden of psoriasis treatment. Understanding the reasons for patient preferences and the perspectives of young adults is needed to guide individual shared decision-making in psoriasis management. Plain Language Summary: Not much research has been done on understanding the disease burden and treatment needs of young adults suffering from psoriasis. This is an interview study with young adults from Nordic countries suffering from moderate to severe psoriasis with an active lifestyle. The adult patients were all referred for biologic treatment of psoriasis but had not yet started treatment when they were interviewed. The aim was to explore treatment preferences in this group. The study showed that treatment goals depended upon both alleviation of symptoms and obtaining a low treatment burden. The most influential symptoms were scaling, itching, and visible plaques. The most important treatment burden features were efficacy, durability, speed of response, safety, and convenience. Understanding the reasons behind these different treatment preferences is essential to help shared-decision psoriasis management that matches individual needs. [ABSTRACT FROM AUTHOR]

Introduction: Certolizumab pegol (CZP) is an Fc-free, PEGylated, anti-tumour necrosis factor biologic. Safety and efficacy data for CZP over 3 years have been previously reported. We report 3-year quality of life (QoL) outcomes for patients treated with CZP, pooled from two phase 3 trials. Methods: Adults with moderate-to-severe plaque psoriasis for ≥ 6 months were initially randomised 1:2:2 to double-blinded placebo every 2 weeks (Q2W), CZP 200 mg Q2W (loading dose of CZP 400 mg at weeks 0/2/4) or CZP 400 mg Q2W. All patients received open-label CZP (200 mg or 400 mg Q2W) from week 48. Dermatology Life Quality Index (DLQI), 36-Item Short Form Survey (SF-36), EuroQol 5-Dimensions 3-Level (EQ-5D-3L) and Work Productivity and Activity Impairment (WPAI) scores are reported as observed. Results: At week 0, 100 patients were randomised to placebo, 186 to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. For CZP-randomised patients, 60.9% had a DLQI score of 0 or 1 by week 48. Both the physical and mental component scores of SF-36 also improved from baseline to week 48 (mean change from baseline: 4.4 and 5.4, respectively). The proportion of patients with a score of 1 in the EQ-5D-3L Pain/Discomfort dimension increased (week 0, 21.1%; week 48, 66.2%), and WPAI Presenteeism, Work Impairment, and Activity Impairment improved from baseline to week 48, with the strongest gains observed for Activity Impairment (week 0, 33.3% of time impaired; week 48, 6.7%). Across patient-reported outcomes, gains were sustained through week 144, with durable improvements observed regardless of sex, psoriatic arthritis status or prior exposure to biologics. Conclusion: CZP treatment was associated with sustained and tangible improvements in health-related QoL (DLQI and SF-36), health status (EQ-5D-3L) and functional impairment at work and in other daily activities (WPAI). Trial Registration: ClinicalTrials.gov NCT02326298 (CIMPASI-1) and NCT02326272 (CIMPASI-2). [ABSTRACT FROM AUTHOR]

Background: Uncontrolled inflammatory disease activity can impact pregnancy outcomes and the health of the mother and child. This retrospective claims database analysis assessed treatment patterns before, during, and after pregnancy among women with inflammatory rheumatic disease (IRD; axial spondyloarthritis [axSpA], psoriatic arthritis [PsA], and rheumatoid arthritis [RA]) or psoriasis (PSO) in Germany. Methods: Data were extracted from the BARMER sickness fund (2013–2017). Pregnant women (18–45 years) with documented IRD or PSO diagnoses were compared with age-matched controls from the same database for the analysis of patient characteristics, healthcare resource utilization, and pharmacological treatment during pregnancy. Reported measures included the proportion of women with pharmacological prescriptions or hospitalization/new prescription of corticosteroids or biologics in the 180 days before pregnancy, during pregnancy, and 180 days after delivery. Pre-specified prescription categories (such as disease-specific drugs [not including biologics]) were identified by anatomical therapeutic chemical classification codes. Extrapolated values to the German statutory health insurance population are reported. Results: Overall, 2702 pregnant women with IRD (axSpA: 1063; PsA: 660; RA: 979) and 6527 with PSO were identified. The proportion of women with IRD receiving prescriptions for disease-specific drugs reduced during pregnancy and remained stable after delivery (before: 15.0%; during: 9.0%; after: 9.7%). The proportion of women with PSO receiving prescriptions for disease-specific drugs was low (before: 0.6%; during: 0.3%; after: 0.1%). The proportion of women with hospitalization/new prescription of corticosteroids or biologics decreased during pregnancy, compared with pre-pregnancy, and increased after delivery in women with IRD (before: 9.0%; during: 5.1%; after: 11.1%) and PSO (before: 3.5%; during: 1.9%; after: 2.7%). Conclusions: A reduction in pharmacological treatment during pregnancy was observed for women with IRD in Germany. Many women with IRD did not return to pre-pregnancy treatments after delivery, despite signs of disease exacerbation, such as hospitalization and initiation of treatment with corticosteroids/biologics, in this period. [ABSTRACT FROM AUTHOR]

Introduction: Combination vaccines improve vaccine uptake and open the infant immunization space for additional vaccines. Hexavalent vaccines have been marketed since 2000. Infanrix hexa (combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine, DTPa-HBV-IPV/Hib, GSK) is longest on the market, providing 16 years post-marketing experience. Each DTPa-HBV-IPV/Hib vaccine component is licensed alone and/or in smaller combination vaccines. Programmatic considerations sometimes require an interchange between vaccines due to unavailability, program change or mixed schedules (when the number of required antigens differs across scheduled primary vaccination visits). Areas covered: Immunogenicity and safety data from 11 GSK-sponsored clinical trials support the interchangeability of DTPa-HBV-IPV/Hib within the same vaccines family, and use of DTPa-HBV-IPV/Hib in mixed primary vaccination schedules. Expert commentary: Data show acceptability of interchange of DTPa-HBV-IPV/Hib with other products within the same vaccines family and its use in mixed immunization schedules. This aligns with WHO recommendations that vaccines of the same family from the same manufacturer be used to complete the infant vaccination schedule. Interchangeability and suitability for use in mixed schedules is of interest for policy-makers/providers in the framework of vaccination recommendations as it provides flexibility. Given the complexity of larger combination vaccines, interchangeability or sequential use needs careful assessment. [ABSTRACT FROM AUTHOR]

Introduction: The development of diphtheria-tetanus-acellular pertussis-Haemophilus influenzaetype b (Hib) conjugate vaccine combinations culminated with hexavalent vaccines, the largest, most complex vaccine combinations in the immunization calendar. Hexavalent vaccines are used widely in Europe and are co-administered with multiple other recommended vaccines. Hib immunogenicity may reduce when combined with acellular pertussis antigens, or in some co-administrations. We reviewed the epidemiology ofH. influenzaedisease in Europe aiming to evaluate the current level of Hib control and indirectly assess the effectiveness against Hib of GSK’s hexavalent vaccine in 10 countries where it is/has been used almost exclusively. Areas covered: We reviewed surveillance data from the European Union Invasive Bacterial Infections Surveillance Network and the European Surveillance System database from 1999–2014 and extracted case and incidence/notification rates (per 100,000 population) of invasiveH. influenzaedisease. We included age and serotype/strains distribution among countries in the European Union/European Economic Area region that reported to the European Centre for Disease Prevention and Control surveillance system. Expert commentary: The impact of Hib vaccination in Europe is sustained, testifying to continued effectiveness against invasive Hib disease after the implementation of hexavalent vaccines into immunization programs, which, since 2006, has been almost exclusively GSK´s hexavalent DTPa-HBV-IPV/Hib vaccine. [ABSTRACT FROM PUBLISHER]

Background: Antibiotic consumption is one of the main causes of bacterial resistance to antibiotics and a major public health problem worldwide, especially in France. A national campaign was implemented in 2001 to reduce the inappropriate use of antibiotics in France, and guidelines for the management of respiratory tract infections were published in 2005. Methods: In this study, data on paediatric outpatient antibiotic use in France between 2000 and 2010 were derived from prescribing panels of the Permanent Survey of Medical Prescription, which analyzed prescriptions by 835 French general practitioners and specialists. Results: Overall, antibiotic prescriptions decreased by 57.2% between 2001 and 2010 in children aged 0-24 months, by 50.0% in children aged 25 months to 6 y, and by 45.8% in children older than 6 y of age. In the 3 age groups, the greatest reduction was for rhinopharyngitis (83.4%) and the lowest was for otitis (22.4%). Because otitis is one of the most common diseases in childhood, the proportion of antibiotic prescriptions due to otitis in children aged 0-24 months consequently increased from 22.5% in 2000 to 42.3% in 2010. Conclusion: Additional measures may be necessary to decrease antibiotic consumption related to otitis in young children. [ABSTRACT FROM AUTHOR]

Background: Introduction of the 7-valent pneumococcal conjugate vaccine (7vCRM) in several countries has led to a rapid, significant drop in vaccine-type invasive pneumococcal disease (IPD) in immunized children. In the United States and some other countries with high antibiotic use, a subsequent rise in serotype 19A IPD has been taken to indicate that the 19F conjugate in the vaccine provides no cross-protection against the immunologically related 19A. Discussion: We systematically assessed the clinical efficacy and effectiveness of 19F-containing vaccines against 19A disease or nasopharyngeal carriage by searching English-language articles in the electronic databases PubMed, Current contents, Scopus, and Embase from 1985 to 2008. The vaccine efficacy and effectiveness point estimates were consistently positive for modest protection against 19A IPD and acute otitis media (AOM). However, statistical significance was not reached in any individual study. No consistent impact of 7vCRM on 19A nasopharyngeal colonization could be detected. These findings are discussed in context of immunogenicity analyses indicating that 7vCRM induces functionally active anti-19A antibodies after the booster dose, and that other 19F-containing vaccine formulations may elicit higher levels of such antibodies after both primary and booster doses. Summary: Taken together, these results suggest that 19F-conjugates can provide some protection against 19A disease. The magnitude of this protection in a given setting will likely depend on several factors. These include the anti-19A immunogenicity of the specific vaccine formulation, the number of doses of that formulation needed to elicit the response, and the burden of 19A disease that occurs after those doses. It is possible that a modest protective effect may be obscured by the presence of countervailing selection pressures (such as high antibiotic use) that favor an increase in colonization with antibiotic-non-susceptible strains of 19A. [ABSTRACT FROM AUTHOR]

Many slow dissociating (insurmountable) non-peptide angiotensin type 1 receptor (AT1) antagonists contain, besides the acidic biphenyltetrazole substructure of losartan, a second acidic group to stabilise antagonist-receptor complexes. To investigate the involved basic amino-acids of the human AT1-receptor, wild-type and mutant receptors were transiently transfected in CHO-K1 cells and characterised by [3H]candesartan binding. Lys199 → Gln substitution decreased the affinity 45-fold for candesartan (95% insurmountable), 18-fold for EXP3174 (70% insurmountable), 10-fold for irbesartan (40% insurmountable) and 5-fold for losartan (surmountable). His256 → Ala substitution had only minor effects. This suggests that Lys199 is important for the tight binding of non-peptide antagonists. [ABSTRACT FROM PUBLISHER]