Bimekizumab: Short-Term Effectiveness and Safety in Real Clinical Practice in Andalucia, Spain.

Introduction: Psoriasis, a chronic inflammatory skin disease, affects 2-10% of the population globally. Bimekizumab (BMK), a monoclonal antibody targeting IL-17, is a dual inhibitor of IL17 A and F that has shown efficacy in treating moderate to severe plaque psoriasis. This real-world evidence (RWE) study aims to assess BMK's efficiency and safety in naïve and refractory patients. Material and methods: A retrospective analysis of a multicenter observational study included 22 patients treated with BMK from April 2023 to February 2023 in five Andalusian hospitals. Ethical approval was obtained, and patients provided informed consent. Assessment criteria encompassed Psoriasis Area and Severity Index (PASI), body surface area (BSA), VAS pruritus, Dermatology Life Quality Index (DLQI), and minimum disease activity (MDA) at 0, 4, 12, and 24 weeks. Results: Patients, predominantly with plaque psoriasis, exhibited significant improvements in PASI (baseline 15.7 to 0.4 at week 16), BSA (baseline 20.7 to 0.43 at week 16), DLQI (baseline 17.93 to 0.43 at week 16), and pruritus (baseline 7.12 to 0.4 at week 16). At week 16, 95.4% achieved MDA. No safety concerns or treatment discontinuations were reported. Discussion: This RWE study aligns with pivotal clinical trials, confirming BMK's efficacy and safety. Notably, BMK demonstrated rapid and sustained psoriasis clearance, even in challenging areas. The study's limitations include a small sample size, suggesting the need for further exploration of patient-reported outcomes. Conclusion: Bimekizumab exhibited optimal efficacy and safety profiles in treating moderate to severe plaque psoriasis in a real-world setting. Rapid response, sustained clearance, and favorable safety outcomes contribute to improved patient experiences. Future research could delve into patient-reported outcomes and expand sample sizes to enhance the understanding of BMK's real-world effectiveness.

Real-World Clinical Experience of Dupilumab in the Treatment of Chronic Palmo-Plantar Eczema in Patients with Moderate-Severe Atopic Dermatitis: 52-Week Follow-Up.

Background: Hand-foot eczema (HFE) are special locations of dermatitis, which are often associated with atopic dermatitis (AD) and have a significant negative impact on the quality of life, demanding a clinically relevant improvement. Objectives: To evaluate the effectiveness and safety of dupilumab in the treatment of eczema localized in hands and/or feet in patients with moderate-to-severe AD. Methods: Retrospective multicenter study of adult patients with HFE treated with dupilumab for their AD. Patients with other concomitantly systemic immunosuppressive treatments did not undergo a washout period. The severity of palmar and/or plantar involvement was assessed using the Physician Global Assessment (PGA) scale on a scale of 0 ( = clear) to 5 ( = very severe). Eczema Area and Severity Index (EASI) and NRS-pruritus scales were also evaluated. One hundred percent of patients reached week 16, while 67/84 reached week 52 of follow-up. Results: A total of 84 patients were included 86.69% of patients showed a reduction in PGA-Hand, and 80.34% in PGA-Foot at week 52, EASI improvement was reached by 83.55% of patients at week 16 and 87.35% at week 52. Reduction of pruritus (≥4 points in NRS-pruritus scale) was 73.01% at week 16 and 80.67% at week 52. No differences in response to dupilumab were observed in the different subtypes of palmo-plantar dermatitis. Conclusions: The results obtained in our study suggest that dupilumab may be an effective and safe therapeutic option for the treatment of dermatitis localized in hands and/or feet.

Multicenter Retrospective Andalusian Study of the Use of Sonidegib for the Treatment of Local Advanced Basal Cell Carcinoma in Real Clinical Practice.

INTRODUCTION: Locally advanced basal cell carcinoma (LA-BCC) is defined as that BCC in which there is radiological confirmation of invasion of certain neighboring structures in depth and also, usually, a BCC that is of a sufficient size and invasion (although there is no radiological demonstration of deep invasion) in which surgery and radiotherapy are not adequate, are insufficient or are contraindicated to achieve the cure of the tumor, either due to characteristics of the tumor itself or of the patient. Sonidegib is indicated for the treatment of adult patients with locally advanced basal cell carcinoma that is not amenable to curative surgery or radiotherapy. MATERIAL AND METHODS: This is a retrospective, multicenter and descriptive study in nine centers in Andalusia, Spain. Patients treated with sonidegib for >3 months for locally advanced BCC were included from 1 January 2021 to 1 January 2023. Epidemiological, efficacy and safety data were collected. RESULTS: In the present study, a total of 38 patients were included, with a median age of 76.23 years (range 40-101). Prior treatment was surgery (31.57%; n = 25), radiotherapy (15.78%; n = 6), vismodegib (31.57%; n = 12). Eleven patients had not received prior treatment. LA-BCC were located in the cephalic pole, face or scalp. There was a total response in 9/38 patients (23.7%), partial response in 25/38 patients (65.8%) and no response in 4 patients (10.52%). In 6/34 patients, the dose was reduced to 200 mg every other day until it was discontinued due to adverse effects. The main adverse effects reported were dysgeusia (n = 8), asthenia (n = 8), = 6), muscle spasms (n = 6), alopecia (n = 4) and gastrointestinal intolerance (n = 4). DISCUSSION: Sonidegib is the second iHh authorized for the treatment of adult patients with locally advanced BCC who are not amenable to curative surgery or radiotherapy, based on the results of the phase II clinical trial, BOLT. Sonidegib shows good effectiveness and an acceptable safety profile in routine clinical practice in the sample presented.

Upadacitinib for moderate to severe atopic dermatitis.

Atopic dermatitis is an inflammatory skin disease, the prevalence of which has increased in the last decade. It affects all age groups, with adult involvement being a major focus of interest in recent years. The unmet needs of the disease, such as pruritus, sleep quality impairment and eczematous skin lesions, have undergone a therapeutic revolution following the commercialization of drugs such as JAK inhibitors. Upadacitinib, a selective JAK1 inhibitor, has been positioned by both clinical trial results and those observed in clinical practice as the fastest and most effective drug in reducing both pruritus and Eczema Area and Severity Index and validated Investigator Global Assessment. Although the safety profile may be initially alarming, it is advisable to update the actual data in this regard for proper management. New perspectives for upadacitinib in nonatopic comorbidities such as psoriasis and alopecia areata are beginning to be described, and interest in learning more about its peculiarities is growing.

Atopic dermatitis is the most common inflammatory skin disease. The inflammation happens when the body's defense system attacks the body's tissue. People with atopic dermatitis often have itching and red and scaly parts of the skin. The inflammation tends to be long-lasting and comes back repeatedly. The main goal of treatment is controlling the inflammation, which occurs because of a certain group of proteins called cytokines. Receptors called JAKs are involved in the inflammation that happens through cytokines, so they play an important role in this disease. A medicine called upadacitinib has been approved for the treatment of moderate to severe atopic dermatitis. In this article, you will find the most relevant published information on upadacitinib, including how effective and safe the medicine is based on both clinical studies and real-life cases.

Treatment of severe atopic dermatitis with tralokinumab in clinical practice: short-term effectiveness and safety results.

BACKGROUND: Tralokinumab was recently approved for the treatment of moderate-to-severe atopic dermatitis (AD) and is the first selective interleukin (IL)-13 inhibitor that specifically neutralizes IL-13 with high affinity. OBJECTIVES: To determine the real-life short-term effectiveness and safety of tralokinumab treatment in patients with moderate-to-severe AD. METHODS: A multicentre retrospective study was conducted including adult patients with moderate-to-severe AD who started tralokinumab treatment from 1 April to 30 June 2022 in 16 Spanish hospitals. Demographic and disease characteristics, severity and quality of life scales were collected at the baseline visit and at weeks 4 and 16. RESULTS: Eighty-five patients were included. Twenty-seven patients (32%) were non-naive to advanced therapy (biological or Janus kinase inhibitors inhibitors). All included patients had severe disease with baseline Eczema Area and Severity Index (EASI) scores of 25.4 (SD 8.1), Dermatology Life Quality Index (DLQI) 15.8 (5.4) and peak pruritus numerical rating scale (PP-NRS) 8.1 (1.8) and 65% had an Investigator's Global Assessment (IGA) of 4. At week 16, there was improvement on all scales. The mean EASI decreased to 7.5 (SD 6.9, 70% improvement), SCORing Atopic Dermatitis improved 64% and PP-NRS, 57%. Also, 82%, 58% and 21% of the patients achieved EASI 50, 75 and 90, respectively. The percentage of EASI 75 responders was significantly higher among the naive vs. non-naive groups (67% vs. 41%). The safety profile was acceptable. CONCLUSIONS: Patients, with a long history of disease and prior multidrug failure, showed a good response to tralokinumab, confirming clinical trial results.

Brodalumab: Efficacy, safety, and survival in mid-term (52 weeks) on real clinical practice in Andalucia, Spain.

INTRODUCTION: Brodalumab is a recombinant monoclonal antibody (IgG2) that binds with high affinity to the human interleukin-17 (IL-17) receptor A and blocks the biological activity of the proinflammatory cytokines IL-17A, IL-17F, IL-17A/F heterodimer, and IL- 25, resulting in inhibition of inflammation and clinical symptoms associated with psoriasis. Its introduction has managed to increase the levels of efficacy, safety (improving that previously presented by the anti-IL-17 class), and survival. MATERIAL AND METHODS: Retrospective analysis of a multicenter, observational study of real clinical practice including patients with moderate to severe plaque psoriasis in treatment with brodalumab. This cross-sectional analysis includes information of patients between February 2019 and February 2022. A total of five tertiary hospitals in Andalusia (Spain) participated in this study. Analyses were performed "as observed" using GraphPad Prism version 8.3.0 for Windows. RESULTS: Our study included 85 patients, 54 men (63.5%) and 31 women (36.5%), with moderate-severe psoriasis treated with brodalumab. In order to evaluate the efficacy of brodalumab, our patients started with mean Psoriasis Area and Severity Index (PASI) values of 12.8 and body surface area (BSA) of 16.9, as well as a Dermatology Life Quality Index (DLQI) of 15.6, highlighting that they reported that the mean baseline visual analog scale (VAS) pruritus was 6.15. On week 52, mean PASI reached 1.26 and mean BSA 2.3, showing a clear stabilization and even sustained improvement regarding results on week 12. Concerning the brodalumab survival, we obtained 85.8% persistence at week 52. DISCUSSION: Brodalumab showed excellent results in the control of psoriasis in the mid-term with an elevated number of patients maintaining treatment after 52 weeks. There were no statistically significant differences in the efficiency, safety, or survival results of brodalumab between patients coming from previous therapies.

Optimising the Therapeutic Interval for Biologics in Patients with Psoriasis.

In our clinical experience, more than half of patients do not present a complete response to biologic drugs, or drug loses its efficacy over time. Plasma determinations of drug and anti-drug antibodies levels are an objective tool for optimisation in these patients; however, established therapeutic ranges are not suitable, so the objective of this study was to study these patients and optimise their healthcare. We have made a retrospective, observational study, using data of plasma levels of drugs and anti-drugs antibodies of infliximab, adalimumab or Etanercept, we summarise all data and make a study of sensitivity, specificity, positive and negative predictive value on current therapeutic ranges. We have found a statistically significant association between subtherapeutic levels and therapeutic failure in psoriasis treated with infliximab and adalimumab. New ranges were found with higher sensitivity than the established ones, we propose 2-10 µg/mL therapeutic range for infliximab, 3-11 µg/mL for adalimumab, and 1-7 µg/mL for etanercept. In conclusion, levels of drug and anti-drug antibodies are a decisive tool for predicting therapeutic response. The current therapeutic ranges may have minimum values that are excessively high, owing to which lowering them significantly increases the sensitivity of the test in all cases, and negative predictive value in the case of etanercept. Further prospective studies are needed to prove the usefulness of these new ranges.

Effectiveness, survival and safety of guselkumab attending to basal characteristics in moderate-to-severe psoriatic patients: a cohort study.

Background: Psoriasis is a chronic inflammatory disease which can impact quality of life. In the past decade multiple biologic treatments have been released with encouraging results. Guselkumab is a monoclonal antibody targeting IL-23p19. Multiple randomized clinical trials have demonstrated its efficacy in psoriasis, but response differences among patient subpopulations have not been extensively reported. Furthermore, patients in real life are often non-eligible for clinical trials and their responses may differ from pivotal studies. Methods: This is a retrospective, observational study of real clinical practice of patients receiving guselkumab treatment in Spain. Patients treated with guselkumab were included between February 2019 to December 2021. This study evaluates the potential differential effect of baseline demographic and disease characteristics on therapeutic responses to guselkumab. We measured effectiveness and survival by the psoriasis area and severity index, the dermatology life quality index as well as Kaplan meier curves, respectively. Categorical and quantitative variables are reported with frequencies, and with mean and standard deviation, respectively. Differences between groups in psoriasis area and severity index and dermatology life quality index, were calculated using a mixed-effects analysis. Survival was calculated using Kaplan meier curves and log-rank tests. Results: A total of 87 patients were included. In this study, our objective was to evaluate the effectiveness, safety and survival of guselkumab attending to demographic characteristics. No differences in psoriasis area and severity index or dermatology life quality index baseline values or therapeutic responses were noted at 52 weeks of follow-up among all the subgroups analysed (age, sex, psoriasis duration, body mass index, and comorbidities). A difference in drug survival was only seen between gender groups. Conclusions: Our research has demonstrated the consistency of guselkumab effectiveness across patient subgroups. No baseline features affected the effectiveness or drug survival of guselkumab, except for lower drug survival in female patients.

Risankizumab: Efficacy, Safety, and Survival in the Mid-Term (52 Weeks) in Real Clinical Practice in Andalusia, Spain, According to the Therapeutic Goals of the Spanish Psoriatic Guidelines.

Introduction. Risankizumab is a humanized monoclonal antibody of the immunoglobulin G1 (IgG1) type that binds selectively, and with high affinity, to the p19 subunit of interleukin-23 (IL-23), resulting in the inhibition of inflammation and clinical symptoms associated with psoriasis. Its introduction has managed to increase the levels of efficacy and safety (improving upon those previously presented by the anti-IL-23 class). Material and methods. Retrospective analysis of a multicenter, observational study of real clinical practice, including patients with moderate-to-severe plaque psoriasis in treatment with risankizumab. This cross-sectional analysis includes information on patients from May 2020 to June 2022. A total of six tertiary hospitals in Andalusia (Spain) participated in this study. Analyses were performed "as observed" using GraphPad Prism version 8.3.0 for Windows. Results. Regarding the percentage of patients who reached PASI 90 or PASI 100 at week 52, 92.5% achieved the therapeutic goal of PASI 90, and 78.5% reached PASI 100. When analyzing the results by absolute PASI, we found that 78.5% (n = 33) obtained PASI 0, 85.7% (n = 36) obtained PASI ≤ 1, and all patients achieved PASI ≤ 3 (disease control). Discussion. Risankizumab has shown promising results in the control of psoriasis in the long-term, with a high percentage of patients (>80%) maintaining PASI 90 and PASI 100 up to 52 weeks of treatment. No abnormal safety findings have been reported, and risankizumab appears to be a solid treatment in the different scenarios analyzed.

Validation of a Questionnaire to Assess the Perception of Women with Atopic Dermatitis in Family Planning.

INTRODUCTION: Atopic dermatitis (AD) is a highly frequent chronic inflammatory skin disease. It is important to know how women with AD approach family planning together with their disease. The aim of the present research is to develop and validate a questionnaire for women diagnosed with AD in order to measure their level of desire and gestational information. MATERIALS AND METHODS: A multicenter cross-sectional study was conducted. Women between 18 and 45 years old with mild, moderate, and severe forms of the disease were included and disease-free controls. An exploratory factorial analysis of the primary components and varimax rotation was used to measure the validity of the construct. Cronbach's α was used to measure the reliability of the individual scales and the global questionnaire. RESULTS: In total, 150 valid questionnaires were included. The final questionnaire consisted of 23 items that converged on six factors. The six scales had adequate reliability: "Pregnancy" (Cronbach's alpha = 0.95), "Conception" (Cronbach's alpha = 0.93), "Concern-information" (Cronbach's alpha = 0.82), "Breastfeeding" (Cronbach's alpha = 0.81), "Sexual life" (Cronbach's alpha = 0.79), and "Family planning" (Cronbach's alpha = 0.67). The total Cronbach's alpha of the questionnaire was 0.94. DISCUSSION: This questionnaire is the first specific measurement instrument developed for women with AD of childbearing age that has demonstrated adequate levels of reliability and construct validity. We consider it useful and valuable to study aspects such as family planning in this patient profile, and that can influence their decision to have offspring.

Tildrakizumab: Efficacy, Safety and Survival in Mid-Term (52 Weeks) in Three Tertiary Hospitals in Andalucia (Spain).

Tildrakizumab (TIL) binds selectively to the p19 subunit of interleukin 23. Its introduction has managed to increase the levels of efficacy, safety (improving that previously presented by the anti-IL-12/23 class) and survival. Retrospective analysis of a multicenter, observational study of real clinical practice including patients with moderate-to-severe plaque psoriasis in treatment with TIL. This cross-sectional analysis includes information of patients between February 2019 to February 2022. A total of three tertiary hospitals in Andalusia (Spain) participated in this study. Analyses were performed "as observed" using IBM SPSS v28 for Windows. A total of 61 patients were included in the analysis. The mean age of our patients was 49.5 years; 50.18% of the patients were female and 34.42% of the patients had a BMI greater than 30. It was notable that 44.26% of our patients had scalp involvement. Almost 35% of the patients had psoriatic arthropathy, although skin involvement was predominant. At week 52 (n = 34), 68% of the patients presented an absolute PASI equal to or less than 1. Regarding the drug survival, eight patients discontinued treatment due to inefficacy: five primary and three secondary failures, and one death due to causes not drug related showing survival of 86% at week 52. In the analysis of subgroups of patients, we found that scalp involvement determined greater survival (94%), as well as a shorter duration of the disease (91.7% vs. 84.4% in those with less than 10 years versus more than 15 years of evolution) and with a lower number of previous biological therapies (100% naïve, 90% in those who have used one line of biological therapy and 82.1% in those who have completed two or more lines of biological treatment. Tildrakizumab showed excellent results in the control of psoriasis in the mid-term with an elevated number of patients maintaining treatment after 52 weeks. There were no statistically significant differences in the efficiency, safety or survival results of TIL between patients coming from previous therapies.

Super-Responders in Moderate-Severe Psoriasis under Guselkumab Treatment: Myths, Realities and Future Perspectives.

A fast skin clearance is the main goal to achieve in psoriasis treatment. Patients that present a fast and exceptional improvement with treatment are called super-responders (SR). There is no consensus on the definition of SR with respect to psoriasis. Included herein is a retrospective analysis of a multicenter, observational study of real clinical practices including patients with moderate-to-severe plaque PSO undergoing treatment with Guselkumab (GUS). This cross-sectional analysis includes information on patients between February 2019 to February 2022. A SR is a patient that achieved a PASI = 0 at weeks 12 and 24. Analyses have been performed "as observed" using GraphPad Prism version 8.3.0 for Windows (GraphPad Software, San Diego, CA, USA, At baseline, the PASI is significantly correlated with VAS_pruritus, BSA, and DLQI, while DLQI is significantly correlated with VAS_pruritus. Significant correlations increase in number and magnitude over the follow-up time. In relation to the univariate logistic models carried out, only three variables showed a significant association with the super-responder variable: depression, VAS_pruritus, and DLQI.SR patients, who show a faster evolution in PASI and BSA improvement than non-SRs. Based on the results obtained, it would be possible to also include DLQI and VAS_pruritus in the broader concept of the SR.

Guselkumab dosing interval optimization in adult patients with moderate-to-severe psoriasis switching from ustekinumab.

Psoriasis (PSO) is an inflammatory disease that emerges as a dysregulation of the interleukin 23 (IL23)/Th17 axis. There are many biologic alternatives to treat PSO that are administered monthly, every 2 months and every 3 months. Guselkumab (GUS) is a fully human monoclonal antibody, that selectively blocks IL-23 through binding to its p19 subunit. There is scarce evidence on dose optimization of GUS in psoriatic patients. Retrospective, observational case series review which includes patients with moderate-to-severe PSO who switched from ustekinumab to GUS as standard dosing or every 12 weeks, regarding daily clinical practice of every dermatology unit. Clinical and demographic data from patients were included from February 2019 to October 2021. Analyses were performed "as observed" using GraphPad Prism version 8.3.0 for Windows (GraphPad Software, San Diego, CA, USA, www.graphpad.com). A total of 30 patients were included in this study: 20 receiving GUS as standard of care (SC) and 10 receiving an optimized dosing (Q12W) (GUS every 12 weeks without induction). The Q12W group presented greater percentage of comorbidities and was less refractory to previous biologic treatments. After receiving GUS as SC or Q12W, psoriasis area severity index and dermatology life quality index improved dramatically in both groups up to 52 weeks. Survival was 87.2% and 100% for the SC and Q12W, respectively, and there were not safety signals. Our case series of 10 patients receiving GUS every 12 weeks without induction showed a good effectiveness and safety profile accompanied by an excellent treatment survival. However, more studies are needed to provide strong evidence of dosing alternatives different than SC.

Long-Term Effectiveness and Safety of Biologic and Small Molecule Drugs for Moderate to Severe Atopic Dermatitis: A Systematic Review.

INTRODUCTION: Atopic dermatitis (AD) is a genetically based chronic inflammatory dermatosis associated with multiple triggers and complex pathophysiological mechanisms. Nowadays, an authentic therapeutic revolution is taking place with the incorporation of biological drugs for the treatment of moderate and severe atopic dermatitis. A new systematic revision (RS) is necessary to support decision-making for specialists treating AD. METHODS: A literature search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials was performed between 1 January 2000 and 30 April 2022. Phase III randomized clinical trials (RCTs) of EMA-approved molecules were included. The main variables analyzed were a 75% improvement in the Eczema Area and Severity Index (EASI 75) and the number of patients who reached 0 in the Investigator Global Assessment (IGA) (fully cleared patients) or IGA 1 (almost cleared patients) at the end of the study period (week 48-60). The risk of bias was analyzed with the Cochrane Risk of Bias Assessment (ROB-2) tool, focused on the primary objectives. Before carrying out the study, the protocol was registered in PROSPERO with the number CRD42022331109. RESULTS: A total of 3299 studies were systematically identified via databases and registers (442 from PubMed/MEDLINE, 2857 from Embase and 719 from CENTRAL). Finally, five publications containing seven RCTs were included in the final sample of detailed data extraction and data analyses. Regarding efficacy, the best results are obtained with Upadacitinib 30 mg (84.7% (77.3-92.1)) at 52 weeks, slightly improving its results when TCS is added (84.9% (80.3-89.5)). These results are replicated in the measurement of vIGA 0/1 for Updacitinib 30 mg + TCS, where 65.5% (55.7-75.2) of patients maintain it at 52 weeks. Of the four drugs, no long-term safety results have been reported for baricitinib. In relation to the safety findings, there were no significant differences in the dropout rates for this reason in the remaining three drugs. DISCUSSION: Today, different therapeutic options for AD patients can be prescribed. Individualizing the treatment allows for better therapeutic consistency, in addition to being cost-efficient to avoid primary therapeutic failures. The results of the present SR may provide us with a useful basis for the preparation of management guidelines for the use of new generation therapies in moderate to severe atopic dermatitis.

Atopic Dermatitis: Background, Objectives and Future Perspectives (Superresponders).

In this Special Issue entitled Atopic Dermatitis: New Perspectives, we have tried to collect research of special interest related mainly to the incorporation of pathophysiological aspects and therapeutic novelties in this regard [...].

Guselkumab as a switching strategy after anti-TNFα, anti-IL17, or anti-IL12/23 therapies in moderate-to-severe psoriasis.

The IL23/Th17 axis plays a strategic role in psoriasis (PSO). Guselkumab (GUS) is a selective inhibitor of the IL23p19 subunit. Its introduction has managed to increase the levels of efficacy, safety and survival in PSO. In real clinical practice, patients can loss effectiveness or suffered adverse events that forces a change in their treatments. There is scarce evidence of the effectiveness, safety, and survival of GUS in real clinical practice after anti-TNFα, anti-IL17, and/or anti-IL12/23. This is multicenter, observational and retrospective study of real clinical practice includes patients with moderate-to-severe plaque PSO in treatment with GUS. The objective of the study was to evaluate the effectiveness of GUS after anti-TNFα, anti-IL17, and anti-IL12/23. The study includes clinical information from February 2019 to February 2022. PASI, BSA, Pruritus, DLQI, survival, and safety were evaluated up to 76 weeks. Analyses were performed "as observed" using GraphPad Prism version 8.3.0 for Windows. A total of 103 patients were included in the analysis. At baseline there were significant differences between the anti-TNF, anti-IL17, and anti-IL12/23 groups for (1) dyslipidemia; (2) number of previous biological treatments and (3) PASI, BSA, VAS Pruritus, and DLQI scores. The effectiveness of GUS in terms of PASI, BSA, Pruritus, and DLQI was not impacted by previous biological alternatives. Treatment survival including discontinuations due to lack of effectiveness or safety reasons was 100%, 92.7%, and 92.1% for anti-TNFα, anti-IL17, and anti-IL12/23, respectively, at 130 weeks. No differences were found between groups. One adverse event was reported in the anti-LI12/23 group. The mid-term effectiveness, safety and survival of GUS if not impacted by previous biological therapy as anti-TNFα, anti-IL17, and/or anti-IL12/23. Our results indicate that GUS could be a switching strategy in patients who fail or present AE to other biological alternatives in moderate-to-severe PSO.

Super responders to guselkumab treatment in moderate-to-severe psoriasis: a real clinical practice pilot series.

BACKGROUND: The term super responders defines a subset of patients with moderate-to-severe psoriasis that present a rapid and higher rate of response to biological treatments in comparison to the general population. Little scientific evidence to explain the behavior and clinical characteristics of these psoriatic patients has been published thus far. Its characterization could be important to improve therapeutic optimization and to identify the profile of patients that will respond efficiently to biological treatments. OBJECTIVES: The main objective of this study was to evaluate and characterize the proportion of super-responder patients (who achieved PASI = 0 at week 12 and 24) in a total of 87 patients with moderate-to-severe psoriasis treated with guselkumab. Also, our intent was to analyze and evaluate differences in response to guselkumab in absolute PASI, PASI 75, PASI 90, PASI 100, BSA, VAS pruritus, and DLQI between groups. RESULTS: A total of 14 out of 87 patients treated with guselkumab were characterized as SR. No differences in demographic characteristics were found. The percentage of patients reaching PASI 75, PASI 90, and PASI 100 were numerically greater for SR than N-SR at week 12, 24, 36, and 52. These differences were more pronounced for PASI 100 > PASI 90 > PASI 75. SR performed better and faster to guselkumab treatment as assessed by absolute PASI, BSA, VAS pruritus, and DLQI. Statistically significant differences were found in absolute PASI, BSA, VAS pruritus, and DLQI between groups along the 52 weeks of study. No differences in drug survival were found between groups (P = 0.3326). CONCLUSION: Our study demonstrated for the first time, in a real clinical practice setting, the presence of a subpopulation of patients that super respond to guselkumab at week 12 and 24 and maintain this efficacy for 52 weeks. Further research must be performed to identify basal specific characteristics of this SR population.