Stella Hartono

All Publications

• A randomized double-blinded trial to assess recurrence of systemic allergic reactions following COVID-19 mRNA vaccination. The Journal of allergy and clinical immunology Khalid, M. B., Zektser, E., Chu, E., Li, M., Utoh, J., Ryan, P., Loving, H. S., Harb, R., Kattappuram, R., Chatman, L., Hartono, S., Claudio-Etienne, E., Sun, G., Feener, E. P., Li, Z., Lai, S. K., Le, Q., Schwartz, L. B., Lyons, J. J., Komarow, H., Zhou, Z. H., Raza, H., Pao, M., Laky, K., Holland, S. M., Brittain, E., Frischmeyer-Guerrerio, P. A. 2024; 153 (6): 1634-1646

  Abstract

  Systemic allergic reactions (sARs) following coronavirus disease 2019 (COVID-19) mRNA vaccines were initially reported at a higher rate than after traditional vaccines.We aimed to evaluate the safety of revaccination in these individuals and to interrogate mechanisms underlying these reactions.In this randomized, double-blinded, phase 2 trial, participants aged 16 to 69 years who previously reported a convincing sAR to their first dose of COVID-19 mRNA vaccine were randomly assigned to receive a second dose of BNT162b2 (Comirnaty) vaccine and placebo on consecutive days in a blinded, 1:1 crossover fashion at the National Institutes of Health. An open-label BNT162b2 booster was offered 5 months later if the second dose did not result in severe sAR. None of the participants received the mRNA-1273 (Spikevax) vaccine during the study. The primary end point was recurrence of sAR following second dose and booster vaccination; exploratory end points included biomarker measurements.Of 111 screened participants, 18 were randomly assigned to receive study interventions. Eight received BNT162b2 second dose followed by placebo; 8 received placebo followed by BNT162b2 second dose; 2 withdrew before receiving any study intervention. All 16 participants received the booster dose. Following second dose and booster vaccination, sARs recurred in 2 participants (12.5%; 95% CI, 1.6 to 38.3). No sAR occurred after placebo. An anaphylaxis mimic, immunization stress-related response (ISRR), occurred more commonly than sARs following both vaccine and placebo and was associated with higher predose anxiety scores, paresthesias, and distinct vital sign and biomarker changes.Our findings support revaccination of individuals who report sARs to COVID-19 mRNA vaccines. Distinct clinical and laboratory features may distinguish sARs from ISRRs.

  View details for DOI 10.1016/j.jaci.2024.03.001

  View details for PubMedID 38460680

  View details for PubMedCentralID PMC11162316

• Interventions for anxiety and depression in patients with atopic dermatitis: a systematic review and meta-analysis. Scientific reports Hartono, S. P., Chatrath, S., Aktas, O. N., Kubala, S. A., Capozza, K., Myles, I. A., Silverberg, J. I., Schwartz, A. 2024; 14 (1): 8844

  Abstract

  Atopic dermatitis (AD) is a chronic inflammatory skin disease that is associated with anxiety and depression. Few studies have addressed interventions for symptoms of anxiety and depression in this population. To determine the efficacy of interventions for anxiety and depression in patients with AD. PubMed, MEDLINE, EMBASE, and PsycINFO were searched from inception to November 2023. English-language studies published in peer-reviewed journals evaluating the effect of interventions on anxiety and/or depression using validated assessment tools on patients with AD were included. Titles, abstracts, and articles were screened by at least two independent reviewers. Of 1410 references that resulted in the initial search, 17 studies were included. Fourteen of these studies are randomized controlled trials, while the other 3 studies are prospective controlled trials with pre and post-test designs. Data were extracted using a standardized extraction form, and the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were followed. To accommodate trials with multiple interventions (each compared to a control group), we conducted a mixed-effects meta-analysis with the trial as a random effect. Prespecified outcomes were changes in symptoms of anxiety and depression in patients with AD as evaluated using standardized assessment tools. Of the 17 studies included in this systematic review, 7 pharmacological intervention studies with 4723 participants examining 5 different medications were included in a meta-analysis. Of these studies, only 1 study evaluated medications prescribed to treat anxiety and/or depression; the rest evaluated medications prescribed to treat AD. Meta-analysis of all the pharmacological interventions resulted in significant improvement in anxiety, depression, and combined anxiety-depression scale scores (standardized mean difference [95% CI]: - 0.29 [- 0.49 to - 0.09], - 0.27 [- 0.45 to - 0.08], - 0.27 [- 0.45 to - 0.08]) respectively. The 10 non-pharmacological studies with 2058 participants showed general improvement in anxiety but not depression. A meta-analysis of the non-pharmacological interventions was not conducted due to variable approaches and limited data. Pharmacological interventions designed to improve AD were found to improve anxiety and depression in patients with moderate-severe disease. More comprehensive studies on non-pharmacological and pharmacological interventions that primarily target anxiety and depression are needed.

  View details for DOI 10.1038/s41598-024-59162-9

  View details for PubMedID 38632375

  View details for PubMedCentralID PMC11024101

• Safety outcomes of SARS-CoV-2 vaccination in pediatric patients with a first dose reaction history or allergy to polyethylene glycol or polysorbate. The journal of allergy and clinical immunology. In practice Hartono, S. P., Sharma, H. P., Bundy, V., Thompkins, J. D., Kochis, S. R., Brooks, J. P. 2022; 10 (8): 2172-2175.e1

  View details for DOI 10.1016/j.jaip.2022.05.035

  View details for PubMedID 35842413

  View details for PubMedCentralID PMC9277098

• Novel STAT1 Gain-of-Function Mutation Presenting as Combined Immunodeficiency. Journal of clinical immunology Hartono, S. P., Vargas-Hernández, A., Ponsford, M. J., Chinn, I. K., Jolles, S., Wilson, K., Forbes, L. R. 2018; 38 (7): 753-756

  View details for DOI 10.1007/s10875-018-0554-3

  View details for PubMedID 30317461

• Gastrointestinal Disorders Associated with Primary Immunodeficiency Diseases. Clinical reviews in allergy & immunology Hartono, S., Ippoliti, M. R., Mastroianni, M., Torres, R., Rider, N. L. 2018

  Abstract

  There are now 354 inborn errors of immunity (primary immunodeficiency diseases (PIDDs)) with 344 distinct molecular etiologies reported according to the International Union of Immunological Sciences (IUIS) (Clin Gastroenterol Hepatol 11: p. 1050-63, 2013, Semin Gastrointest Dis 8: p. 22-32, 1997, J Clin Immunol 38: p. 96-128, 2018). Using the IUIS document as a reference and cross-checking PubMed ( www.ncbi.nlm.nih.pubmed.gov ), we found that approximately one third of the 354 diseases of impaired immunity have a gastrointestinal component [J Clin Immunol 38: p. 96-128, 2018]. Often, the gastrointestinal symptomatology and pathology is the heralding sign of a PIDD; therefore, it is important to recognize patterns of disease which may manifest along the gastrointestinal tract as a more global derangement of immune function. As such, holistic consideration of immunity is warranted in patients with clinically significant gastrointestinal disease. Here, we discuss the manifold presentations and GI-specific complications of PIDDs which could lead patients to seek advice from a variety of clinician specialists. Often, patients with these medical problems will engage general pediatricians, surgeons, gastroenterologists, rheumatologists, and clinical immunologists among others. Following delineation of the presenting concern, accurate and often molecular diagnosis is imperative and a multi-disciplinary approach warranted for optimal management. In this review, we will summarize the current state of understanding of PIDD gastrointestinal disease involvement. We will do so by focusing upon gastrointestinal disease categories (i.e., inflammatory, diarrhea, nodular lymphoid hyperplasia, liver/biliary tract, structural disease, and oncologic disease) with an intent to aid the healthcare provider who may encounter a patient with an as-yet undiagnosed PIDD who presents initially with a gastrointestinal symptom, sign, or problem.

  View details for DOI 10.1007/s12016-018-8689-9

  View details for PubMedID 29754192

• Predictors of granulomatous lymphocytic interstitial lung disease in common variable immunodeficiency. Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology Hartono, S., Motosue, M. S., Khan, S., Rodriguez, V., Iyer, V. N., Divekar, R., Joshi, A. Y. 2017; 118 (5): 614-620

  Abstract

  A subset of patients with common variable immunodeficiency (CVID) develop granulomatous lymphocytic interstitial lung disease (GLILD), which is associated with early mortality.To determine a set of clinical and/or laboratory parameters that correlate with GLILD.A retrospective, nested case-control (patients with CVID diagnosed with GLILD compared with patients with CVID without a diagnosis of GLILD) medical record review was undertaken at Mayo Clinic, Rochester, MN. Network and univariate analysis was used to identify clinical and laboratory parameters at the time of diagnosis that are associated with GLILD.Twenty-six cases with radiologic evidence of GLILD were included in this study. Eighteen cases (69%) cases had coexistent splenomegaly with lower IgA levels (P = .04) compared with the controls. Patients with low IgA levels (<13 mg/dL) also had percentage expansion of low CD21 B cells (CD21low >5%) (P = .007). Univariate analysis revealed that splenomegaly (odds ratio [OR], 17.3; 95% confidence interval [CI], 3.9-74.5), history of immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA) (OR, 4.8; 95% CI, 1.1-20.2), low IgA level (OR, 3.6; 95% CI, 1.2-11.9), and percentage expansion of CD21low (OR, 5.8; 95% CI, 1.6-24.7) were independently associated with GLILD. Logistic regression analysis revealed that splenomegaly, history of ITP or AIHA, low IgA level, and percentage expansion of CD21low B cells are highly sensitive in predicting presence of GLILD (area under the receiver operating curve of 0.86).Presence of splenomegaly, history of ITP or AIHA, low serum IgA level, and percentage expansion of CD21low B cells may be useful to identify a group of patients at high risk for development of GLILD.

  View details for DOI 10.1016/j.anai.2017.01.004

  View details for PubMedID 28254202

• No! When the immunologist becomes a virologist: Norovirus - an emerging infection in immune deficiency diseases. Current opinion in allergy and clinical immunology Hartono, S., Bhagia, A., Joshi, A. Y. 2016; 16 (6): 557-564

  Abstract

  Norovirus infection is an emerging chronic infection in immunocompromised hosts. The aim of this review is to discuss the pathophysiology of Norovirus infection and explore mechanistic models for chronic infection/shedder state, especially in patients with immune deficiency diseases.Chronic Norovirus infection is increasingly associated with enteropathy associated with both primary and secondary immune deficiency diseases. There is an ongoing debate in the immune deficiency community whether it is truly a causative agent for the enteropathy or it is an innocent bystander.We describe the historic aspects of Norovirus infection, its immunology and viral structure and the basis for preventive and vaccination strategies.We also postulate in this review a disease model in immune deficiency subjects which creates a milieu for it to become a chronic and explore newer frontiers for disease modification and prevention.Norovirus is the most common cause of acute gastroenteritis in general population but the factors that lead to its persistence in patients with immune deficiency need further holistic studies. This should include host assessment, microbiome signatures, and viral pathogenic factors assessment.

  View details for DOI 10.1097/ACI.0000000000000323

  View details for PubMedID 27755184