Drug Reactions Research Articles

Attitudes and Experiences of Patients Regarding Gender-Specific Aspects of Pain Management.

Biological, pharmacological, and socio-cultural aspects influence gender-specific effects in pain management. Gender-specific aspects of pain management were assessed in a rural outpatient center via semi-structured patient interview: (i) general gender aspects (total population) from 1 = "fully disagree" to 5 = "fully agree"; and (ii) individual pain (matched pairs) via numeric analog scale (NAS) from 0 = "no pain" to 10 = "maximum pain". Patient charts were assessed for pain management (WHO-ladder). In total, 113 patients were enrolled (59.18 [SD: 12.76] years, 46% female, 54% male, 0% diverse), and 42 were matched into female-male pairs. (i) Women and men agreed that men and women should be treated equally despite biological differences (median: 5 [women] vs. 5 [men]; p = 0.789). As a reason for gender-specific aspects, "medication concentration" was reported more frequently by women (p = 0.038) and "no answer" by men (p = 0.014). (ii) Mean value (SD) of pain (NAS) was 4.0 (SD 2.3) for women and 3.3 (SD 2.6) for men (p = 0.215) with a positive correlation between pain management escalation (WHO-ladder) and the pain score (NAS) only in men (r = 0.704, p = 0.001). Women rather reported an influence of adverse drug reactions on treatment contentment than men (p = 0.042). Although patients pleaded for gender-independent equal treatment, gender-specific differences in pain therapy were found.

Safety and effectiveness of lenalidomide in Japanese patients with relapsed/refractory ATLL: post-marketing surveillance.

Lenalidomide is an oral immunomodulatory agent approved for the treatment of relapsed/refractory adult T-cell leukemia/lymphoma (ATLL) in Japan. Post-marketing surveillance (PMS) was conducted to confirm its safety and effectiveness. From April 2017 until April 2020, safety data were obtained for 77 patients and effectiveness data for 65 patients (31.2% of patients had progressive disease as the best response to their most recent prior regimen). Forty-nine patients (63.6%) in the safety analysis set experienced an adverse drug reaction (ADR). Grade ≥ 3 ADRs occurred in 42.9%. The most common Grade ≥ 3 ADRs were neutrophil count decreased/neutropenia and platelet count decreased/thrombocytopenia (11.7% each). Serious ADRs occurred in 26 patients. Five patients had previously received allogeneic hematopoietic stem cell transplantation. Among these, one experienced acute graft versus host disease (GvHD) during lenalidomide administration and two responded to lenalidomide. Effectiveness analysis showed that an objective response was achieved in 29.2% of patients. No statistically significant differences were observed in the objective response rates of patients aged < 70 versus those aged ≥ 70years (33.3% vs 28.0%, respectively; p = 0.6904). No new safety signals were observed in this PMS, and lenalidomide demonstrated a favorable benefit-risk balance in Japanese patients with ATLL.

Impact of hospital outpatients’ experiences of patient safety on fear of infection: a secondary analysis of national data

IntroductionAmid the COVID-19 pandemic, outpatients’ concerns about infection risk have increased. It is crucial to understand the factors that contribute to this fear of infection to promote patient safety and...

Factors affecting the level of medication adherence to anti-diabetic treatment: A multi- center cross-sectional study in Eastern Bhutan

Background: Worldwide, Diabetes Mellitus affects millions of people. It is a chronic and progressive disease requiring a long-term treatment plan, adherence to which becomes extremely challenging. Globally, there is a poor level of medication adherence to anti-diabetic treatment and several studies have explored the factors affecting medication adherence. However, in Bhutan, there is limited data on the rate of medication adherence and factors affecting it. . Therefore, the study aimed to find the level of anti- diabetic medication adherence and factors affecting it. Methods: A multicenter cross-sectional observational study was conducted involving six eastern district hospitals from June 2019 to February 2020. Research participants were randomly selected from the daily cohort of patients visiting diabetic clinics. Results: Amongst the 390 participants, the overall level of adherence reported in this study was intermediate with a mean Morisky Medication Adherence Scale 8 Items (MMAS-8) score of 6.06 (95% CI 5.91-6.22). Nearly 40% demonstrated a low level of adherence (MMAS-8 score &lt;6). There was a statistically significant (p&lt;0.05) association between mean MMAS-8 scores and adverse drug reactions, the drug regimen (polypharmacy or monotherapy) and the type of diabetes mellitus. Conclusion: This study revealed an intermediate level of medication adherence to anti-diabetic treatment in the eastern region of Bhutan. Adverse drug reactions and polypharmacy resulted in a lower level of adherence. However, further studies are needed to draw a definitive conclusion.

Who can benefit more from its twelve-week treatment: A prospective cohort study of blonanserin for patients with schizophrenia

BACKGROUND Blonanserin (BNS) is a well-tolerated and effective drug for treating schizophrenia. AIM To investigate which types of patients would obtain the most benefit from BNS treatment. METHODS A total of 3306 participants were evaluated in a 12-week, prospective, multicenter, open-label post-marketing surveillance study of BNS. Brief psychiatric rating scale (BPRS) scores were calculated to evaluate the effectiveness of BNS, and its safety was assessed with the incidence of adverse drug reactions. Linear regression was used to screen the influencing factors for the reduction of BPRS total score, and logistic regression was used to identify patients with a better response to BNS. RESULTS The baseline BPRS total score (48.8 ± 15.03) decreased to 27.7 ± 10.08 at 12 weeks (P &lt; 0.001). Extrapyramidal symptoms (14.6%) were found to be the most frequent adverse drug reactions. The acute phase, baseline BPRS total score, current episode duration, number of previous episodes, dose of concomitant antipsychotics, and number of types of sedative-hypnotic agents were found to be independent factors affecting the reduction of BPRS total score after treatment initiation. Specifically, patients in the acute phase with baseline BPRS total score ≥ 45, current episode duration &lt; 3 months, and ≤ 3 previous episodes derived greater benefit from 12-week treatment with BNS. CONCLUSION Patients in the acute phase with more severe symptoms, shorter current episode duration, fewer previous episodes, and a lower psychotropic drug load derived the greatest benefit from treatment with BNS.

Risk prediction models for adverse drug reactions and adverse drug events in older adults-a systematic review and meta-analysis.

Adverse drug reactions (ADRs) are common and result in significant morbidity, mortality, and associated hospital costs. Models predicting ADRs in older adults were previously found to lack reliability and validity. This systematic review and meta-analysis aim to provide an updated, comprehensive quality assessment and analysis of ADR-risk prediction tools in older adults. Standard databases and citations were searched (2012 to 2023) and studies which developed and/or validated an ADR prediction model for use in older adults were included. Four studies from a previous systematic review were also included. The TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) checklist was used to evaluate each study. Random effects models were used to derive a pooled discrimination estimate (area-under-the-receiver-operation curve; AUROC) for model development and validation studies. Eight studies, describing 6 ADR-risk prediction models met the inclusion criteria). In the meta-analysis, the pooled AUROC was 0.75 (95% CI 0.57, 0.87; I-squared = 96.88%) for model development studies and 0.73 (95% CI 0.52, 0.87; Isquared = 90.19%) for externally validated studies. Studies had poor adherence (range 34-50%; median 46.5%; IQR 12%) to TRIPOD guidelines. The studies identified through this systematic review exhibit poor adherence to TRIPOD guidelines which may question the investigational rigor and the usability of the models. This underscores the urgent need to develop a validated, robust, and reliable tool worthy of implementation and testing in a real-world setting to gauge its impact and usability effectively.

Quantifying the potential contribution of drugs to the occurrence of acute kidney injury in patients with chronic kidney disease

Abstract Background We sought to comprehensively describe drug-related components associated with AKI in patients with CKD, describing the incidence of drug-related AKI, the proportion of preventable AKI, identified the various drugs potentially associated with it, explored the risk factors, and assessed the one-year incidences of the recurrence of drug-related AKI, kidney failure, and death. Methods CKD-REIN is a French national prospective cohort of 3,033 nephrology outpatients with a confirmed diagnosis of CKD (eGFR &amp;lt;60 mL/min/1.73 m²). AKIs and adverse drug reactions (ADRs) were prospectively identified from hospital reports, medical records, and patient interviews. Expert nephrologists used the KDIGO criteria to adjudicate all stages of AKI, and expert pharmacologists used validated tools to adjudicate ADRs (including drug-related AKIs). Results Over a median [interquartile range] period of 4.9 [3.4-5.1] years, 832 cases of AKI were reported in 639 (21%) of the 3,033 study participants. The drug-related component associated with AKI accounted for 236 cases, and 28% were judged to be preventable or potentially preventable. The three most frequently implicated drug classes were diuretics, renin-angiotensin system inhibitors, and contrast agents. A history of cardiovascular events, diabetes, lower levels of hemoglobin and eGFR, poor medication adherence, and ≥ 5 drug taken daily were associated with a greater risk of drug-related AKI. Full recovery was not attained in 64 (27%) of the 236 cases of drug-related AKI. The one-year cumulative incidences of recurrence of drug-related AKI, kidney replacement therapy, and death were 7%, 15%, and 11%, respectively, after the first drug-related AKI. Conclusions Drug-related AKI is prevalent among patients with CKD. Even though a substantial proportion of these events were classified as stage 1, our findings point to a poor prognosis.

Hydroxychloroquine-induced acute generalized exanthematous pustulosis with HLA-typing.

Acute generalized exanthematous pustulosis (AGEP) is a rare drug reaction characterized by numerous pustules on an erythematous base. In some cases, hydroxychloroquine (HCQ) can cause AGEP. There is an association between HLA genes and AGEP according to pharmacogenomic studies. In this case report, we present the case of a 36-year-old female who developed HCQ-induced AGEP with HLA-typing. According to our findings, the patient had HLA-B 58:01, HLA-C 08:01, and HLA-A 02:06. A pharmacoeconomic perspective of HLA genotyping before drug prescription is shown in this result.

Adverse drug reactions and its associated factors among geriatric hospitalized patients at selected comprehensive specialized hospitals of the Amhara Region, Ethiopia: a multicenter prospective cohort study

BackgroundAdverse drug reactions are more prevalent in geriatric patients and are frequently associated with a range of polypharmacy-related issues as well as some physiological aging-related alterations. These affect the pharmacokinetic and pharmacodynamic properties of drugs. This study aimed to assess the magnitude of ADRs and their contributing factors among geriatric patients admitted at Comprehensive Specialized Hospitals of the Amhara Region.MethodsA multicenter prospective cohort study was carried out from May 2023 to August 2023 on geriatric patients admitted to four randomly selected comprehensive hospitals in the Amhara region. We used logistic regression to find the factors influencing the occurrence of ADRs. A P value of less than 0.05 was deemed statistically significant.ResultsDuring the study’s follow-up period, 373 patients in total were included. An incidence rate of 31.10% (95% CI: 26.38–35.82) was obtained from the identification of 121 ADRs in total. The organ most frequently affected by ADRs was the gastrointestinal tract (28.92%), followed by the cardiovascular system (19.01%), and the drug class most often implicated in ADRs was antibiotics (21.49%), then anticoagulants (12.40%). ADRs were substantially linked to being overweight (P < 0.001), having been hospitalized in the previous six months (P = 0.000), and hyperpolypharmacy (p = 0.047). 93.39% of all ADRs received the interventions. 85.12% of the adverse drug reactions were successfully resolved.ConclusionsThis study found that over one-third of older people and individuals admitted to the hospital experienced ADRs. Overweight, hyperpolypharmacy, and patients who had previously been admitted during the preceding six months were significantly linked with the occurrence of ADRs. Improving the drug safety of elderly patients, particularly those who are admitted, should be a greater priority for healthcare professionals.

A Novel Spectrofluorimetric Method for Vibegron in the Newly FDA Approved Pharmaceutical Formulation and in Human Plasma: Analytical QbD Strategy for Method Development and Optimization.

Vibegron is a novel selective beta-3 adrenergic receptor agonist molecule, recently approved by US Food and Drug Administration (FDA) in tablet pharmaceutical formulation for treating overactive bladder syndrome. Such formulation necessitates the development of a simple, fast and cost-effective methodology capable of assaying the drug in various real samples with high sensitivity. Herein, a facile and robust spectrofluorimetric method was introduced, for the first time, for vibegron quantification based on analytical quality-by-design approach. The method involves drug reaction with dansyl chloride at pH 9.8, as a smart approach to overcome the non-fluorescent nature of vibegron, giving a highly fluorescent yellow derivative measured at 514nm after being excited at 345nm. Plausible reaction scheme between the drug and dansyl chloride was elucidated through studying the differences in their infrared (IR) spectra. Variables affecting fluorescence intensities were carefully screened and rationally optimized via preliminary scouting studies and central composite design for accurate and robust results. Full International Council for Harmonisation (ICH) validation protocol was followed where linearity was achieved in range of 20.0-400.0 ng/mL with minimum detectability of 3.6 ng/mL. The proposed method expressed good capability in assaying the marketed dosage forms with no excipient inference. Finally, the high sensitivity of such method paved the way for extending its application to quantify vibegron in spiked human plasma at concentrations around its real human plasma concentrations for further bioavailability studies.

A Prospective Study of Adverse Drug Reactions to Antipsychotic Agents and its Causality Assessment in Psychiatry Ward of a Tertiary Care Hospital

A Prospective Study of Adverse Drug Reactions to Antipsychotic Agents and its Causality Assessment in Psychiatry Ward of a Tertiary Care Hospital

Rheumatic Immune-Related Adverse Events With Anti-cyclic Citrullinated Peptide Positivity and Cutaneous Adverse Drug Reactions: A Case Report

Rheumatic Immune-Related Adverse Events With Anti-cyclic Citrullinated Peptide Positivity and Cutaneous Adverse Drug Reactions: A Case Report

Safety and Effectiveness of Elotuzumab in Japanese Patients with Relapsed/Refractory Multiple Myeloma: A Post-marketing Surveillance Study.

Objective Elotuzumab plus lenalidomide and dexamethasone (ELd) was approved in Japan in 2016 for the treatment of relapsed/refractory multiple myeloma (RRMM). This post-marketing surveillance study evaluated the safety and effectiveness of ELd in RRMM patients during routine clinical practice in Japan. Methods Elotuzumab safety was assessed by evaluating adverse drug reactions (ADRs), and effectiveness was assessed primarily by the best overall response. Patients The study enrolled patients with RRMM who received ELd therapy between November 18, 2016, and June 18, 2017. The safety and effectiveness analysis sets included 831 and 755 patients, respectively. Results In the safety analysis set, patients received a median (range) of 12 (1-40) elotuzumab administrations over 108 (1-728) days of treatment. The relative dose intensity of elotuzumab was ≥90% in 74.1% of patients. ADRs and serious ADRs were reported in 41.2% and 15.2% of the patients, respectively. The most common ADR was infection (12.0%), followed by lymphocytopenia (10.1%), infusion reactions (7.5%), secondary malignancies (e.g. gastric cancer and pancreatic carcinoma), cataracts, and interstitial lung disease (0.2% each). While most patients with ADRs recovered, 71 discontinued treatment, and 14 deaths were reported. The presence of comorbidities, particularly cardiovascular disorders, significantly affected the safety. The overall response rate was 41.1%. Conclusion This all-case post-marketing surveillance study showed that ELd had an acceptable tolerability profile and promising clinical activity in Japanese patients with RRMM.

Characteristics of the current situation of drug use in elderly patients with chronic diseases in Chongqing: A cross-sectional survey.

Following improved accessibility to medical services, the phenomenon of polypharmacy in elderly patients with comorbidity has been increasing globally. Polypharmacy patients are prone to drug interactions, adverse drug reactions, and even the risk of death etc. Therefore, there is an urgent need to fully understand the current status and characteristics of drug use in elderly patients with chronic diseases, focusing on polypharmacy factors to ensure that medications for elderly patients are effective and safe. To collect and analyze the characteristics of the current drug use situation in elderly patients with chronic diseases in Chongqing and further explore the influencing factors for polypharmacy, providing references for formulating more effective and safe medication regimens for elderly patients. Most elderly patients affected with chronic diseases in Chongqing were willing to go to hospitals or pharmacies to buy medicines. However, they were not familiar with their disease conditions and drug-related adverse reactions and could not be regularly followed up or monitored. The number of diseases, medications, and adverse drug reactions increased with the increasing age of elderly patients. The problem of irrational use of drugs in elderly patients with chronic diseases was relatively prominent, especially the use of traditional Chinese medicines. The medication situation in elderly patients with chronic diseases was not optimistic, and the problem of polypharmacy was relatively prominent. Further large-scale studies are needed to provide a certain reference for improving the current status of drug use in elderly patients.

Efficacy and safety of remimazolam tosylate for patients undergoing off-pump coronary artery bypass grafting: a study protocol for a non-inferiority randomised controlled trial in China

IntroductionMaintaining haemodynamic stability is crucial but challenging during the induction and maintenance of general anaesthesia (GA) in patients undergoing off-pump coronary artery bypass grafting (OPCABG). Remimazolam tosylate is a novel...

One-strength dose escalation of house dust mite depot product for subcutaneous immunotherapy is safe and tolerable.

Allergen immunotherapy (AIT) aims at modulating the immune response by administration of allergen preparations at regular intervals over several years (1). For subcutaneous AIT (SCIT), the treatment is initiated with a dose escalation phase followed by a maintenance dose administration. Over the last decade, there has been a trend towards shortening dose escalation regimens to increase patient adherence. This open-label, phase II trial aimed to investigate the safety and tolerability of a house dust mites (HDMs) SCIT product when used in a newly designed one-strength dose escalation scheme. Patients, aged 12-65, suffering from HDM-allergic rhinitis/rhinoconjunctivitis ± asthma were included. Patients were randomized to the one-strength (6 injections from the highest strength 3) or the Standard dose escalation regimen (14 injections from strengths 1 to 3) using the HDMs-SCIT product. All adverse events were reported. Tolerability was assessed on the Likert scale. One hundred and forty-three patients were randomized, 79 adults and 64 adolescents. In total, the one-strength regimen caused more adverse drug reactions (ADRs) than the Standard regimen (p = .0457). With both regimens most ADRs were local reactions which occurred more often in the one-strength group (p = .0393). But there was no significant difference in the number of patients affected by systemic or serious ADRs between both regimens. No relevant differences occurred between the two age groups and no other risks were observed for adolescents compared to adults. The safety and tolerability of both regimens can be considered comparable, as most ADRs were local reactions, primarily rated as mild in intensity. Nevertheless, the one-strength regimen caused more ADRs. Reducing the number of injections from 14 to 6 while using only one strength offers the potential to improve patient adherence which further might increase clinical efficacy. Future trials could confirm this hypothesis.

Treatment of Acanthamoeba keratitis with high dose PHMB (0.08%) monotherapy in clinical practice: A case series.

Acanthamoeba keratitis (AK) is a rare sight-threatening infectious disease with no approved pharmacological treatments. Topical polihexanide 0.8 mg/ml (PHMB 0.08%) completed a pivotal clinical trial showing a medical cure rate of 84.9%. The purpose of this study is to evaluate the efficacy and safety of PHMB 0.08%, given as monotherapy, in clinical practice. consecutive cases of AK were included. Diagnosis was confirmed by in vivo confocal microscopy or PCR. Patients were treated with PHMB 0.08% as part of a name-based compassionate use program. Treatment delivery frequency and termination were as advised in the pivotal clinical trial. Medical cure was defined as clinical evidence of healed epithelium and absence of corneal inflammation lasting 3 months after discontinuing all treatments. twelve eyes of 11 contact lens wearers with AK of variable severity were evaluated. Eleven of 12 (91.7%) eyes achieved a medical cure with no surgery. One eye had a corneal perforation and required emergency therapeutic keratoplasty. The median time of treatment with PHMB 0.08% was 100 days (range 35-222). Seven eyes (58.3%) reached a final visual acuity of 20/50 Snellen or better. Two subject reported worsening of conjunctival hyperaemia during the intensive phase of the treatment. No other adverse drug reactions were observed. topical treatment with PHMB 0.08% monotherapy successfully cured AK in 11 of 12 eyes when used in real-world clinical practice, thereby confirming that results observed in the clinical trial could be obtained in this setting.

Real-world research on beta-blocker usage trends in China and safety exploration based on the FDA Adverse Event Reporting System (FAERS)

BackgroundBeta-blockers are widely used, with continuously updated clinical recommendations. However, their application faces challenges in personalized treatment and safety. The study aimed to investigate the frequency and patterns of prescribing beta-blockers in China and to explore potential adverse event risk signals associated with beta-blockers, providing reference for rational medication use in clinical settings.MethodsPrescription data for beta-blockers from January 2018 to June 2023 were extracted through the Hospital Prescription Analysis Collaborative Project in China to analyze clinical usage trends. While adverse drug reaction reports for beta-blockers were obtained from the FDA Adverse Event Reporting System (FAERS) database. The classification and standardization of adverse drug event (ADE) reports were based on the preferred terms (PT) and corresponding system organ classes (SOC) from the Medical Dictionary for Regulatory Activities (MedDRA). Signal detection utilized a proportion imbalance method.ResultsIn clinical practice, metoprolol dominated beta-blocker prescriptions in China, accounting for 62.2%. Beta-blockers were primarily prescribed to the elderly (65.7%) and male patients (57.0%). However, off-label use of beta-blockers was relatively widespread. For instance, sotalol was prescribed for hypertension at 18.25%, while esmolol was used for angina and heart failure at rates of 12.94% and 14.98%, respectively. In addition, we identified newly discovered adverse reactions associated with beta-blockers, such as BRASH syndrome (metoprolol: n = 186, ROR = 391.285; carvedilol: n = 72, ROR = 256.459), acute kidney injury (bisoprolol: n = 247, ROR = 5.641), premature baby (labetalol: n = 110, ROR = 91.385), and sleep disorder (propranolol: n = 254, ROR = 10.98).ConclusionsMetoprolol led the beta-blocker market in China. Attention was warranted regarding the newly discovered adverse reactions, such as the risk of acute kidney injury with bisoprolol and the potential for BRASH syndrome with metoprolol and carvedilol.

Prospects for the use of perampanel in the treatment of epilepsy in patients with malignant gliomas of the brain

Epilepsy occurs in 35–95% of patients with low-grade malignant cerebral gliomas and in 29–71% of patients with high-grade gliomas. Seizures can be the first manifestation of a malignant cerebral glioma or may develop in the postoperative period and during chemoradiation therapy. This necessitates the use of antiepileptic drugs that can control seizures, ensure seizure prevention, and provide secondary seizure prophylaxis without reducing the effectiveness of anticancer therapy or the patient’s quality of life. The processes of epileptogenesis and oncogenesis are closely interrelated through common developmental mechanisms, with glutamate playing a key role. Increased glutamate secretion is accompanied by elevated expression and activation of its receptors, which raises seizure susceptibility. This is associated with increased levels of brain-derived neurotrophic factor, the number of synapses between peritumoral neurons and glioma cells, and the expression of various growth factors, all of which contribute to tumor progression. In this context, special attention is given to perampanel, a glutamate receptor antagonist and third-generation antiepileptic drug, in the treatment of epilepsy in patients with malignant cerebral gliomas. It has been shown that perampanel not only effectively controls seizures in patients with malignant cerebral gliomas but also suppresses tumor progression. Perampanel can dose-dependently enhance apoptosis and disrupt cell migration in malignant glioma cell lines. A synergistic effect of perampanel in combination with temozolamide has been identified. During chemoradiation therapy, perampanel exerts a protective effect on healthy peritumoral tissues. Adverse drug reactions associated with perampanel use are infrequent and mild. Further research is needed to investigate the anticonvulsant and antitumor efficacy of perampanel for the treatment of epilepsy in patients with malignant brain tumors.

Real-world safety and effectiveness of adalimumab in patients with pyoderma gangrenosum: Interim analysis of a post-marketing observational study in Japan.

Pyoderma gangrenosum (PG) is a rapidly progressive disease characterized by deep ulcers, predominantly in the lower extremities. Adalimumab, a monoclonal antibody against tumor necrosis factor alpha, is the first drug approved for PG treatment in Japan, ahead of other countries. We conducted a multicenter, open-label, post-marketing observational study to evaluate the safety and effectiveness of adalimumab in Japanese patients with PG. Of 67 patients enrolled, 37 in the safety analysis set and 32 in the effectiveness analysis set were included in this interim analysis. (Nineteen patients whose case report forms were not collected and 11 whose data were not fixed by the data cut-off date were excluded from the study). In the safety analysis set, the mean age was 62.9 years and 86.5% of patients had comorbidities, including ulcerative colitis (21.6%), diabetes mellitus (18.9%), and hypertension (10.8%); subtypes of PG included ulcerative (n = 33), vegetative (n = 2), and pustular (n = 2). Mean exposure duration to adalimumab was 185.5 days. Systemic steroids were used before (70.3%) and during (56.8%) adalimumab treatment. The incidence proportion of overall adverse drug reactions was 18.9%. The incidence proportions of all infections and serious infections reported as adverse drug reactions were 13.5% and 10.8%, respectively. The proportion of patients with a Physician Global Assessment score (total lesions) of 0/1 at weeks 12, 26, and 52 was 42.9%, 36.8%, and 50.0%, respectively. This interim analysis revealed the characteristics of Japanese patients with PG treated with adalimumab in the actual clinical setting and the real-world safety and effectiveness of adalimumab. At the time of the interim analysis, adalimumab treatment was generally well tolerated, and no new safety concerns were detected. Further follow-up of this study will provide a more detailed understanding of the long-term safety and effectiveness of adalimumab in patients with PG refractory to conventional treatments.