Pfizer (Spain)

The patient's perspective is increasingly relevant in health decision making. In daily practice, care of patients with migraine should include evaluation of their satisfaction with acute and preventive treatments, the interference with daily living, as well as with the care received by the healthcare team. The aim was to develop and validate a novel specific self-reported patient-reported-experience measure (PREM) in Spanish (Spain), to ascertain satisfaction with migraine treatment; the MISAT-Q questionnaire. A multicenter, crosssectional, non-interventional study was conducted between June 2023 and March 2024 in headache units in Spain. Patients with migraine currently receiving treatment were included. A 35-items preliminary instrument was developed after literature review and cognitive debriefing with experts and patients. Three samples were used: a) 23 patients to assess feasibility/pertinence of items; b) 158 patients for item reduction; and c) 209 patients for validation of PREM. Measures for concept validity included Patient Global Impression of change (PGI), Headache Impact Scale-6 items (HIT-6), and Health-Related Quality-of-life (EQ-5D-3 L). Feasibility, reliability and validity (content, discriminant, construct, and concurrent) were assessed. Feasibility: face value (good acceptance to answer the questionnaire), administration time (below 10 minutes), floor and ceiling effects (below 40% in any extreme response category), percentage of missing values in each item (below 20%) was found in the validation sample. Factor analysis item reduction resulted in a 22-item questionnaire with 7 dimensions: undesirable side effects, treatment effectiveness in crisis and in prevention, convenience-of-use, impact on daily activities, medical care, and global satisfaction, supported with confirmatory factor analysis: CFI = 0.983; TLI = 0.980; χ2/df = 1.808; RMSEA = 0.075. Reliability was high: Cronbach's alpha = 0.90 and intraclass-correlation coefficient = 0.95. Dimensions of questionnaire showed significant and moderate convergent correlations with the overall score (0.58-0.68, p < 0.001). Concurrent validity with HIT-6 showed correlation's coefficients ranging from -0.19 to -0.48 (p < 0.01 in all cases, except medical care) and with EQ-5D-3 L (correlations from 0.17 to 0.39, p < 0.05 in all cases, except medical care). Differences in satisfaction were found according with migraine severity (F = 6.73, p = 0.002), as well as in HIT-6 scores (F = 8.20, p < 0.002). MISAT-Q discriminated overall satisfaction between patients with worse, no change and better change with treatment (F = 15.85; p < 0.001). The MISAT-Q questionnaire is a well-accepted, reliable and valid measure of migraine treatment satisfaction in Spanish. Responsiveness attribute needs to be explored. This novel PREM may facilitate clinicians when making health decision in the treatment management of patients with migraine.

IntroductionAllergic comorbidities are common in patients with atopic dermatitis (AD). Individual trials with abrocitinib or dupilumab demonstrated efficacy and safety in patients with moderate-to-severe AD and allergic comorbidities. This post hoc analysis of the phase 3 JADE COMPARE and DARE trials compared efficacy, safety, and quality of life following abrocitinib and dupilumab treatment in adults with moderate-to-severe AD, with or without comorbid asthma, allergic rhinitis, or food allergy.MethodsData were pooled from patients who received abrocitinib (200 mg/day) or dupilumab (300 mg/every 2 weeks) for 16 weeks with concomitant topical therapy. Assessments by self-reported asthma, allergic rhinitis, or food allergy included the proportion of patients achieving Investigator’s Global Assessment of clear or almost clear (IGA 0/1), ≥ 75% improvement in Eczema Area and Severity Index (EASI-75), ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4), least squares mean change from baseline in Dermatology Life Quality Index (DLQI) and SCORing Atopic Dermatitis (SCORAD), and safety.ResultsOf 1195 patients (abrocitinib, n = 588; dupilumab, n = 607), 377 (32%), 225 (19%), and 211 (18%) patients self-reported comorbid asthma, food allergy, or allergic rhinitis, respectively. Week 16 IGA 0/1 responses were comparable between patients with/without comorbidity with abrocitinib (52%/54% [with/without asthma], 50%/54% [with/without allergic rhinitis], and 53%/53% [with/without food allergy]) or dupilumab (42%/42%, 37%/43%, and 47%/41%). EASI-75 and PP-NRS4 responses and DLQI and SCORAD improvements were also comparable between patients with/without comorbidity in each treatment arm. Treatment-emergent adverse events were more common in patients with comorbidities in the abrocitinib (76%/67% [with/without asthma], 80%/67% [with/without allergic rhinitis], and 78%/67% [with/without food allergy]) and dupilumab (71%/53%, 71%/57%, and 62%/59%) arms.ConclusionAbrocitinib and dupilumab improved AD signs and symptoms with a manageable safety profile in patients with moderate-to-severe AD, regardless of asthma, allergic rhinitis, or food allergy.Graphical available for this article.Trial RegistrationClinicalTrials.gov identifier, NCT03720470 (JADE COMPARE) and NCT04345367 (DARE).Graphical Supplementary InformationThe online version contains supplementary material available at 10.1007/s13555-025-01516-w.

A. J. Olszewski, K. Aizawa, Y. H. Karimi, D. Sano, S. Y. Oh, A. Neuhof, D. Bouyoucef-Cherchalli, J. Wang, A. SyBing, M. Rodriguez, and V. T. G. Lin equally contributing author. Introduction: Although advances in adaptive, T cell-engaging immunotherapy have improved the prognosis of patients (pts) with relapsed/refractory diffuse large B cell lymphoma (R/R DLBCL), activation of innate immunity is a novel therapeutic approach. Maplirpacept is a recombinant SIRPα-blocking fusion protein designed to enhance phagocytosis and antitumor activity by disrupting inhibitory CD47-SIRPα signaling and has shown preliminary efficacy against DLBCL. This Phase 1b/2 study (NCT05626322) aimed to evaluate the safety, tolerability, and clinical benefits of the maplirpacept, tafasitamab, and lenalidomide combination in R/R DLBCL pts who are ineligible for high-dose chemotherapy (HDC) and/or autologous stem cell transplantation (ASCT). Results from the Ph1b trial are presented. Methods: Pts were aged ≥ 18 years with histologically confirmed R/R DLBCL, had ≥ 1 line of prior systemic treatment (tx; including an anti-CD20 containing regimen), and were not candidates for HDC/ASCT. Pts received maplirpacept IV 4 mg/kg, 10 mg/kg or 18 mg/kg + tafasitamab IV 12 mg/kg + lenalidomide 25 mg orally. For Ph1b, the primary objective was evaluation of dose-limiting toxicities (DLTs) during the 28-day DLT observation period; secondary objectives were safety, antitumor activity, pharmacokinetics (PK) and immunogenicity. Results: At data cut-off (December 13, 2024), 6 pts were evaluable for safety, and 5 were evaluable for DLTs. Median age was 58.5 years (range 40–81), 3 pts were male, 2 had bulky disease (longest diameter ≥ 7.5 cm), 3 had > 1 prior lymphoma-directed tx. No pts experienced DLT. Tx-emergent adverse events (TEAEs) of grade (G) ≥ 3 experienced by ≥ 2 pts were neutropenia (4 pts), thrombocytopenia, sepsis, and urinary tract infection (2 pts each). Maplirpacept tx-related AEs (TRAEs) G ≥ 3 were neutropenia (2 pts), thrombocytopenia and anemia (1 pt each). Three pts experienced serious AE (SAE); sepsis was the only SAE reported in > 1 pt. One TR-SAE (leukemia) resulted in death, unrelated to maplirpacept; a second death (cardiac arrest) occurred > 28 days after the last tx dose and was deemed unrelated to study tx. No TEAEs led to study tx discontinuation. TRAEs leading to dose interruption of maplirpacept were reported in 2 pts. Objective responses were observed in 4 pts, and all were complete responses; 1 pt had stable disease. The median duration of response was 9.6 mos; median progression free survival was 11.4 mos; median duration of tx with maplirpacept was 37 wks. Maplirpacept PK concentrations were consistent with previous datasets. No pts experienced anti-drug antibodies. Conclusions: Addition of maplirpacept to tafasitamab and lenalidomide showed clinical activity and tolerable safety profile in pts with R/R DLBCL. Although this trial was discontinued due to enrollment challenges, further development of maplirpacept for R/R DLBCL continues in NCT05896163. A genAI tool (Feb25; Pfizer; GPT-4o) developed draft 1; authors assume content responsibility. Research funding declaration: The study is sponsored by Pfizer. Medical writing support was provided by Haniya Javaid, BSc, of Engage Scientific Solutions, and funded by Pfizer. A Pfizer proprietary AI tool was used with author review to develop the first draft (February 2025); authors take full responsibility for the content. Keyword: immunotherapy Potential sources of conflict of interest: A. J. Olszewski Consultant or advisory role: Genmab, Blue Cross and Blue Shield of Rhode Island, Schrodinger, ADC Therapeutics, BeiGene, Bristol-Myers Squibb Other remuneration: Research Funding: Genentech/Roche, Precision Biosciences, Genmab, Artiva, Pfizer, Kymera Y. H. Karimi Consultant or advisory role: Yes Honoraria: Yes Other remuneration: Speakers Bureau, and Research Funding A. Neuhof Employment or leadership position: Pfizer employee Stock ownership: Yes D. Bouyoucef-Cherchalli Employment or leadership position: Pfizer employee Stock ownership: Yes J. Wang Employment or leadership position: Pfizer employee A. SyBing Employment or leadership position: Pfizer employee M. Rodriguez Employment or leadership position: Pfizer employee Stock ownership: Yes

Early treatment initiation is one of the strongest predictors of good treatment response in axial spondyloarthritis (axSpA). Recently, the Assessment in SpondyloArthritis International Society (ASAS) defined early axSpA as a diagnosis of axSpA with a duration of axial symptoms equal to or less than 2 years. Tofacitinib is a Janus kinase (JAK) inhibitor for the treatment of ankylosing spondylitis. Compare the efficacy and safety of tofacitinib versus placebo (both on non-steroidal anti-inflammatory drug (NSAID) background) in patients with active early axSpA and inadequate response to at least one NSAID. This is a phase IV, randomized, double-blind, placebo-controlled, multicenter clinical trial. The study will recruit 104 patients aged ⩾18 and ⩽45 years with active early axSpA (chronic back pain ⩽2 years), inadequate response to at least one NSAID, and objective signs of active inflammation (on magnetic resonance imaging (MRI) of sacroiliac joints (SIJs) or elevated C-reactive protein). Patients will be randomized 1:1 to receive tofacitinib 5 mg twice daily or placebo, with background naproxen 500 mg twice daily for 16 weeks. Patients not meeting early treatment response criteria at week 4 will receive open-label tofacitinib until week 16. Primary and key secondary endpoints at week 16 will be the proportion of patients achieving disease remission (Axial Spondyloarthritis Disease Activity Score <1.3) and change from baseline in MRI SIJ Spondyloarthritis Research Consortium of Canada osteitis score, respectively. Safety will be monitored up to 4 weeks after the last study drug dose. The study will be performed according to the ethical principles of the Declaration of Helsinki and will be approved by independent ethics committees of each center. This is one of the first randomized clinical trials designed to evaluate the efficacy and safety of a JAK inhibitor in the recently ASAS-defined "early" axSpA population. Trial registration: ClinicalTrials.gov: NCT06112665; CTIS: 2023-505050-18-00.

We aimed to describe the risk profile of respiratory syncytial virus (RSV) infections among adults ≥ 60years in Valladolid from January 2010 to August 2022, and to compare them with influenza and COVID-19 controls. This was a retrospective cohort study of all laboratory-confirmed RSV infections identified in centralized microbiology database during a 12-year period. We analyzed risk factors for RSV hospitalization and severity (length of stay, intensive care unit admission, in-hospital death or readmission < 30days) and compared severity between RSV patients vs. influenza and COVID-19 controls using multivariable logistic regression models. We included 706 RSV patients (635 inpatients and 71 outpatients), and 598 influenza and 60 COVID-19 hospitalized controls with comparable sociodemographic profile. Among RSV patients, 96 (15%) had a subtype identified: 56% A, 42% B, and 2% A + B. Eighty-one percent of RSV patients had cardiovascular conditions, 65% endocrine/metabolic, 46% chronic lung, and 43% immunocompromising conditions. Thirty-six percent were coinfected (vs. 21% influenza and 20% COVID-19; p = < .0001 and 0.01). Ninety-two percent had signs of lower respiratory infection (vs. 85% influenza and 72% COVID-19, p = < .0001) and 27% cardiovascular signs (vs. 20% influenza and 8% COVID-19, p = 0.0031 and 0.0009). Laboratory parameters of anemia, inflammation, and hypoxemia were highest in RSV. Among RSV, being a previous smoker (adjustedOR 2.81 [95% CI 1.01, 7.82]), coinfection (4.34 [2.02, 9.34]), and having cardiovascular (3.79 [2.17, 6.62]), neurologic (2.20 [1.09, 4.46]), or chronic lung (1.93 [1.11, 3.38]) diseases were risks for hospitalization. Being resident in care institutions (1.68 [1.09, 2.61]) or having a coinfection (1.91[1.36, 2.69]) were risks for higher severity, while RSV subtype was not associated with severity. Whereas RSV and influenza patients did not show differences in severity, RSV patients had 68% (38-84%) lower odds of experiencing any severe outcome compared to COVID-19. RSV especially affects those with comorbidities, coinfections, and living in care institutions. RSV vaccination could have an important public health impact in this population.

Background. Mepolizumab, a monoclonal antibody that interacts with IL-5, was the first anti-IL-5 approved for uncontrolled severe eosinophilic asthma. In several randomised, placebo-controlled trials, treatment with mepolizumab has shown a significant improvement in asthma symptoms and the need to use of oral corticosteroids (OCS). Several studies have correlated blood levels of eosinophil cationic protein (ECP) with the degree of eosinophilic inflammation, which could make it an indirect marker of eosinophilic activity. Methods. This was a single-centre retrospective study that included all patients diagnosed with severe eosinophilic asthma under treatment with mepolizumab. We recorded the number of exacerbations, daily prednisone intake, asthma control test scores and forced expiratory volume in the first second. Results. We followed 22 patients, 14 of whom were OCS-dependent with a mean daily dose of 15.85 ± 15.62 mg prednisone. After 12 months, only five continued taking OCS and the mean daily dose was reduced by up to 2.50 ± 3.84 mg (p less than 0.007). The exacerbation rate at baseline was 2.91 ± 2.27 and decreased to 0.82 ± 1.14 in the following year (p less than 0.001). ACT scores increased significantly from 16.00 ± 5.85 to 20.71 ± 4.45 after six months (p = 0.003). We also observed a decrease in ECP from 81.46 ± 43.99 µg/L to 19.12 ± 18.80 µg/L (p > 0.001). Conclusions. These real-life results are consistent with previous clinical trials demonstrating the efficacy and safety of mepolizumab in routine clinical practice for severe uncontrolled eosinophilic asthma. We observed a significant decrease in blood eosinophil counts and in ECP levels, suggesting a reduction in eosinophil activity following mepolizumab treatment.

Targeting B-cell maturation antigen (BCMA) on myeloma cells has led to improved clinical benefit in heavily pretreated patients with relapsed or refractory multiple myeloma (RRMM), including those patients with triple-class exposed disease.1 Elranatamab, a humanized BCMA-CD3 bispecific antibody, was approved for the treatment of patients with RRMM based on the results from the registrational MagnetisMM-3 study, which enrolled patients previously treated with at least one immunomodulatory drug, one proteasome inhibitor, and one anti-CD38 monoclonal antibody.2, 3 Among BCMA-naive patients (n = 123), treatment with elranatamab led to an objective response rate (ORR) of 61.0%, with 35.0% of patients achieving a complete response (CR) or better.4 After a descriptive median follow-up of 14.7 months (data cutoff approximately 14 months after the last patient's initial dose), the median progression-free survival (PFS) and overall survival (OS) had not been reached, making it difficult to contextualize the survival outcomes in the treatment landscape for RRMM.4 Here, we report updated results, including Kaplan–Meier estimates of PFS and OS after a longer follow-up. As of the data cutoff of March 26, 2024 (approximately 26 months after the last patient's initial dose), with a median follow-up of 28.4 months (95% confidence interval [CI], 28.0–29.0; estimated by reverse Kaplan–Meier), the ORR was 61.0%, with 37.4% of patients achieving CR or better. Among responders, the median duration of response was not yet reached, and the probability of maintaining response at 24 months was 66.9% (95% CI, 54.4–76.7). The median PFS was 17.2 months (95% CI, 9.8–not-estimable [NE]) (Figure 1) and the median OS was 24.6 months (95% CI, 13.4–NE) (Figure 2). No new safety signals emerged with longer follow-up. Hematologic adverse events in ≥25% (any grade, maximum grade 3/4) of the patient population included neutropenia (49.6%, 49.6%), anemia (48.8%, 37.4%), thrombocytopenia (31.7%, 23.6%), and lymphopenia (26.8%, 25.2%). Other adverse events of interest observed in patients included infections (70.7%; 42.3% maximum grade 3/4; 6.5% grade 5), cytokine release syndrome (57.7%; all grade ≤2), and immune effector cell–associated neurotoxicity (4.9%; all grade ≤2). Elranatamab monotherapy continues to improve survival outcomes without new safety signals. Despite the refractory patient population with a high percentage of patients with poor prognostic features in MagnetisMM-3, the median PFS of 17.2 months and the median OS of 24.6 months observed with additional follow-up are promising among bispecific antibodies currently approved for RRMM. In an analysis of MajesTEC-1 with a median follow-up of 23 months, BCMA-naive patients treated with teclistamab had a median PFS of 11.3 months (95% CI, 8.8–16.4) and a median OS of 21.9 months (95% CI, 15.1–NE).5 In the MonumenTAL-1 trial, talquetamab, a bispecific antibody against CD3 and G-protein-coupled receptor, class C, group 5, member D (GPRC5D) showed a median PFS of 7.5 and 11.9 (61% censored) months in the once-weekly and once every 2 weeks dosing cohorts after a median follow-up of 14.9 and 8.6 months, respectively.6 The observed safety profile with elranatamab is consistent with that of teclistamab as well as other BCMA-targeted bispecific antibodies.5, 7-10 In conclusion, extended follow-up from the ongoing phase 2 MagnetisMM-3 trial of elranatamab in BCMA-naive patients with heavily pretreated RRMM demonstrated sustained clinical efficacy and no new safety signals. We wish to thank the patients who participated in the trial and medical staff of participating centers. Medical writing support was provided by William Clafshenkel, PharmD, PhD, of Nucleus Global and was funded by Pfizer. All authors were involved in the trial conception/design or the acquisition, analysis, or interpretation of data. All authors contributed to the drafting of the manuscript and approved the final version. Michael H. Tomasson: consulting or advisory roles for Janssen. Shinsuke Iida: honoraria from Bristol Myers Squibb, Celgene, Janssen, Pfizer, Sanofi, and Takeda; consulting or advisory roles for Janssen, Sanofi, and Takeda; and research funding from AbbVie, Amgen, Bristol Myers Squibb, Caelum Biosciences, Celgene, Daiichi Sankyo, Janssen, Ono, Otsuka, Sanofi, and Takeda. Ruben Niesvizky: consulting or advisory roles for Bristol Myers Squibb, GSK, Janssen, Karyopharm Therapeutics, and Takeda and research funding from Bristol Myers Squibb, GSK, Janssen, Karyopharm Therapeutics, and Takeda. Mohamad Mohty: honoraria from Amgen, Celgene; consulting or advisory roles for Adaptive Biotechnologies, GSK, Jazz Pharmaceuticals, MaaT Pharma, Novartis, Sanofi, and Xenikos; personal fees from Amgen, Astellas, Bristol Myers Squibb, Celgene, Pfizer, Stemline-Menarini and Takeda; and speakers bureau roles for Janssen, Jazz Pharmaceuticals, and Sanofi. Nizar J. Bahlis: honoraria from AbbVie, Amgen, Celgene, Genentech/Roche, GSK, Janssen, Karyopharm Therapeutics, Sanofi, and Takeda; consulting or advisory roles for Amgen, Celgene, Janssen, Karyopharm Therapeutics, Pfizer, Sanofi, and Takeda; personal fees from AbbVie, Amgen, Celgene, Genentech/Roche, GSK, Janssen, Karyopharm Therapeutics, Sanofi, and Takeda; and patents, royalties, and/or other intellectual property interests with Celgene and Janssen. Joaquin Martinez-Lopez: consulting or advisory roles for Bristol Myers Squibb, Janssen, and Novartis; research funding from Astellas and Bristol Myers Squibb; and speakers bureau roles for Bristol Myers Squibb, Janssen-Cilag, and Roche. Paula Rodriguez-Otero: consulting or advisory roles for AbbVie, Bristol Myers Squibb, GSK, Janssen, Pfizer, and Sanofi; personal fees from AbbVie, Celgene, GSK, H3 Biomedicine, Janssen, Pfizer, and Sanofi; travel and accommodations expenses paid by Pfizer; and speakers bureau roles for Bristol Myers Squibb, GSK, Janssen, and Sanofi. Alexander M. Lesokhin: honoraria from iTeos Therapeutics, Janssen, Legend Biotech, Pfizer, Sanofi, and Trillium Therapeutics; consulting or advisory roles for Pfizer, Trillium Therapeutics, and Arcellx; personal fees from iTeos Therapeutics, Janssen, Legend Biotech, Pfizer, Sanofi, and Trillium Therapeutics; research funding from Bristol Myers Squibb, Genentech, Janssen, Pfizer, Sanofi, and Trillium Therapeutics; and patents, royalties and/or other intellectual property interests with Serametrix. Andrea Viqueira, Eric Leip, Umberto Conte, and Sharon T. Sullivan: employment and stock ownership at Pfizer. Guenther Koehne: has no conflicts of interest. This study was conducted in accordance with the International Council for Harmonisation guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki. The study protocol was approved by local or independent institutional review boards or ethics committees at participating sites. This study was funded by Pfizer. Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified patient data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information.