Treatment adherence to oral chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer: Protocol for a hospital pharmacy-based real-world study.

OBJECTIVE: This article describes a study protocol for evaluating adherence to oral chemotherapy (OCT) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in Spain. METHODS: This multicenter, observational, prospective study will be conducted by 6 hospital pharmacists from 6 Spanish hospitals. The study will include men and women aged 18 years or older with a diagnosis of locally advanced or metastatic NSCLC who are being treated or have been prescribed OCT. Once included, the patient will be active and prospectively followed up for 3 months, including 4 study visits to record information on sociodemographic variables, antineoplastic treatment and adherence, pharmaceutical care, clinical variables, and patient-reported outcomes (PRO) (the 3-level version of EQ-5D, the EORTC Core Quality of Life Questionnaire, the Brief Illness Perception Questionnaire, the Treatment Satisfaction with Medicines Questionnaire, and the PRO version of Common Terminology Criteria for Adverse Events). Twelve months after patient inclusion, we will record information on the disease progression status and dispensed prescriptions. The primary outcome is the percentage of treatment adherence that will be calculated based on the pill count as follows: the difference between the number of pills dispensed minus the number of unused pills will be divided by the number of days of treatment multiplied by the number of pills/day prescribed by the oncologist; this quotient will be multiplied by 100 to obtain the percentage of adherence. Based on the that pill count reconciliation, those with a percentage adherence >80% will be primarily categorized as adherent. Secondarily, treatment adherence will be also calculated based on the proportion of days covered and the 4-items Morisky Green Levine Medication Adherence Scale. To analyze the impact of patients' and treatment characteristics on adherence, bivariate analyses will be performed using different adherence cut-off points. To evaluate the impact of adherence on treatment efficacy as evaluated by progression-free survival, we will be using the Kaplan-Meier method and compare it with the log-rank test and univariate Cox regression analysis. CONCLUSIONS: We expect that our study will provide initial information on key aspects of adherence to OCT (i.e., measurement, facilitators, and barriers) and its relationship with patients' and clinically relevant outcomes in the setting of NSCLC, and that this information will help in designing pharmaceutical interventions to improve adherence.

Therapeutic Drug Monitoring in Oncohematological Patients: A Fast and Accurate HPLC-UV Method for the Quantification of Nilotinib in Human Plasma and Its Clinical Application.

Nilotinib, a second-generation tyrosine kinase inhibitor, has demonstrated clinical activity in chronic myeloid leukemia. As an exposure-response relationship has been observed for nilotinib, its therapeutic drug monitoring could be a valuable tool in clinical practice. Therefore, the aim of this study was to develop and validate a selective and precise high performance liquid chromatography-ultraviolet method for the measurement of nilotinib in plasma from patients with cancer. After protein precipitation extraction with acetonitrile, nilotinib and rilpivirine were separated using isocratic elution on a Tracer Excel 120 ODS C18 column using a mobile phase consisting of a mixture of potassium dihydrogen phosphate-buffered solution (pH 5.5; 0.037 M)-methanol-acetonitrile (45:45:10, v/v/v), pumped at a flow rate of 1.7 mL·min-1. A wavelength of 254 nm was selected for the quantification of the analyte and the internal standard (IS). The technique was validated following the guidelines for the validation of analytical methods of regulatory agencies (Food and Drug Administration (FDA) and the European Medicines Agency (EMA)). Linearity was established in a concentration range between 125 and 7000 ng/mL. The detection limit was 90 ng/mL, and the lower limit of quantification was 125 ng/mL. For all concentrations in the calibration curve, the intraday and interday coefficients of variation were less than 4.1%. Median recovery of nilotinib from plasma was ≥65.1% (±21.4%). The method described is sensitive, selective, reproducible, and rapid, and can be used for the accurate determination of nilotinib in human plasma for pharmacokinetics studies and for therapeutic drug monitoring (TDM) of nilotinib in routine clinical practice.

Six months multicentre pilot open label single-arm study to evaluate patient experience, acceptability and satisfaction of switching certolizumab pegol from a prefilled syringe or autoinjection pen to an AVA® e-Device in rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis patients.

WHAT IS KNOWN AND OBJECTIVE: The study aimed to assess acceptability and patient experience of Certolizumab (CZP) self-injection with AVA® and clarify patient device preference after switching CZP from the syringe or auto-injection pen to AVA® in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) patients. METHOD: A multicentre open-label, cross-sectional and prospective study among four Spanish hospitals was performed. Adult RA, PsA, axSpA patients treated for at least 6 months with the CZP syringe or pen were recruited. At the first visit, patients completed Pre-AVA® questionnaire. Patients were instructed on proper administration of CZP by AVA®. After 2 and 6 months of CZP self-injections using the AVA®, patient experience, adherence, preference and safety of each administration was assessed using post-AVA® questionnaire. RESULTS AND DISCUSSION: Thirty four patients were included (28 women). All patients self-administered CZP AVA® the full dose of CZP was injected. Patients reported >90% adherence to CZP AVA® assessed with the injection log. Pain at the injection site was reduced after switching to AVA®. Twenty nine patients preferred CZP AVA® and five patients preferred the CZP pen. No safety-related findings related to AVA® CZP administration were identified. WHAT IS NEW AND CONCLUSION: The AVA® is an advantageous delivery option for CZP in patients with RA, PsA, axSpA.

Effect of Early Peripheral Parenteral Nutrition Support in an Enhanced Recovery Program for Colorectal Cancer Surgery: A Randomized Open Trial.

BACKGROUND: Peripheral parenteral nutrition allows repletion of acute nutrient deficiencies and could prevent further nutrition deficits before and after colorectal surgery. A randomized open study was performed to evaluate the effect of perioperative peripheral parenteral nutrition (PPN) support on postoperative morbidity after colorectal cancer surgery within an enhanced recovery program. METHODS: Patients were randomized into two groups: peripheral parenteral nutrition (PPN) (with Peri-Olimel N4-E) versus conventional fluid therapy (FT). Ninety-day postoperative complications, laboratory parameters, length of hospital stay, and compliance with the ERAS protocol were assessed. RESULTS: A total of 158 patients were analysed. The overall 90-day complication rate was 38.6% (61 patients), and 24 patients had major complications (Clavien-Dindo III-V) (15.2%). In the multivariate analysis, the intervention (PPN vs. FC) showed a protective effect against postoperative complications (p = 0.0031, OR = 0.2 (CI: 0.08-0.87)). Following ordinal regression, PPN and early oral tolerance showed a protective effect, being less likely to develop complications or to move from minor to major complications. In patients with low compliance to ERAS during the first postoperative day, PPN showed a protective effect, preventing 28% of morbidity. CONCLUSIONS: Perioperative peripheral parenteral nutrition (PPN) support with Peri-Olimel N4-E in colorectal cancer surgery associated with early oral intake could reduce postoperative complications.

Health and economic impact of the correct diagnosis of transthyretin cardiac amyloidosis in Spain.

Objective: To estimate the health and economic impact of the reduction in mortality and cardiovascular hospitalizations, associated with correct diagnosis of cardiac transthyretin amyloidosis (ATTR-CM), from the Spanish National Health System (NHS) perspective.Methods: A costs and effects analysis were performed (probabilistic Markov model) with time horizons between 1 and 15 years, comparing the correct diagnosis of ATTR-CM versus the non-diagnosis. Transition probabilities were obtained from the ATTR-ACT study (placebo arm) and from the literature. Costs and healthcare resources were obtained from Spanish sources (€ 2019) and from a panel of Spanish clinical experts.Results: After 1, 5, 10 and 15 years, the diagnosis of ATTR-CM would generate a gain of 0.031 (95%CI 0.025; 0.038); 0.387 (95%CI 0.329; 0.435); 0.754 (95%CI 0.678; 0.781) and 0.944 (95%CI 0.905; 0.983) life years per patient, respectively, with savings of € 212 (95%CI € -632; 633), € 2,289 (95%CI € 2,250; 2,517), € 2,859 (95%CI € 2,584; 3,149) and € 2,906 (95%CI € 2,669; 3,450) per patient, respectively, versus the non-diagnosis.Conclusions: Just by correctly diagnosing ATTR-CM, years of life would be gained, cardiovascular hospitalizations would be avoided, and savings would be generated for the NHS, compared to the non-diagnosis of the disease.

Midazolam and haloperidol for palliative sedation: physicochemical stability and compatibility of parenteral admixtures

This study was done to determine the time while the binary admixtures with midazolam and haloperidol drugs are administered by perfusion to the patients in the clinical routine. Samples with different concentrations of both drugs were prepared following the usual clinical practice. Solvents used were 0.9 % sodium chloride solution and 5% dextrose, and viaflo plastic bags were used as the containers of the admixtures. Samples were not protected from light and were stored at 20 ºC or at 4 ºC. Compatibility and physicochemical stability were studied by visual inspection, turbidity measurement, pH determination and ultraviolet detection high performance liquid chromatography (UV-HPLC) was used to determine midazolam and haloperidol concentrations. The assay was validated following the FDA and EMA guidelines. Darunavir was used as internal standard (IS). For the studied admixtures, turbidity measurements and pH determinations showed little changes in function of the time. Haloperidol and midazolam concentrations determined by HPLC are within the acceptable range of drug concentrations, which are considered stable for four days in case of admixtures stored at 20 ºC and for seven days for refrigerated admixtures. Taking into account the microbiological risk matrix, the compatibility and the chemical and microbiological stability of the midazolam and haloperidol in the co-administered admixtures in viaflo plastic bags with 0.9 % sodium chloride solution and 5% dextrose can be set as 48 hours when samples are stored at 20 ºC and one week if they are refrigerated.

Relationship between the rs1414334 C/G polymorphism in the HTR2C gene and smoking in patients treated with atypical antipsychotics. / Relación entre el polimorfismo rs1414334 C/G del gen HTR2C y tabaquismo en pacientes tratados con antipsicóticos atípicos.

An association has been found between the C allele of the rs1414334 polymorphism in the HTR2C gene and the metabolic syndrome in psychiatric patients. However, no study has yet evaluated whether this allele is associated with smoking. To assess this issue, therefore, we performed a cross-sectional study with a sample of 166 adult patients treated with atypical antipsychotics in 2012-2013 in a region of Spain. The primary variable was the presence of the C allele of the rs1414334 polymorphism in the HTR2C gene. Secondary variables were the number of pack-years (number of cigarettes per day x number of smoking years ÷ 20), age, gender, schizophrenia, years since diagnosis, metabolic syndrome criteria and SCORE. A stepwise binary logistic regression model was constructed to determine associations between primary and secondary variables and their area under the ROC curve (AUC) was calculated. Of the total sample, 33 patients (19.9%) had the C allele of the polymorphism analyzed. Mean cigarette consumption was 11.6 pack-years. The multivariate analysis showed the following factors as associated with the polymorphism: higher cigarette consumption, being a woman, and not having abdominal obesity. The AUC was 0.706. An association was found between increased cigarette consumption over the years and the presence of the C allele of the rs1414334 polymorphism in the HTR2C gene.

En pacientes psiquiátricos, otros autores han encontrado una asociación entre el alelo C del polimorfismo rs1414334 del gen HTR2C y el síndrome metabólico. Ninguno de ellos ha valorado si este alelo se asocia con el consumo de tabaco, por lo que se decidió realizar un estudio en una región española valorando esta cuestión. Estudio observacional transversal de una muestra de 166 pacientes adultos tratados con antipsicóticos atípicos en 2012-2013. Variable principal: presencia del alelo C del polimorfismo rs1414334 del gen HTR2C. Variables secundarias: número de años-paquete (número de cigarrillos al día x número de años fumando ÷ 20), edad, sexo, esquizofrenia, años diagnosticados del trastorno, criterios de síndrome metabólico y SCORE. Se construyó un modelo de regresión logística binaria por pasos para determinar asociaciones entre la variable principal y las variables secundarias del estudio y se calculó su área bajo la curva ROC (ABC). Del total de la muestra, 33 pacientes presentaron el alelo C del polimorfismo analizado (19,9%). El consumo de tabaco medio fue de 11.6 paquetes-año. El modelo multivariante arrojó los siguientes factores asociados al polimorfismo: mayor consumo tabáquico, ser mujer y no tener obesidad abdominal. El ABC fue de 0,706. Se ha encontrado asociación entre un mayor consumo de tabaco a lo largo de los años y la presencia del alelo C del polimorfismo rs1414334 del gen HTR2C. Se necesitan trabajos que corroboren nuestros resultados.

[Subcutaneous drug administration in palliative care]. / Administración de medicamentos por vía subcutánea en cuidados paliativos.

OBJECTIVE: Develop a guide that compiles all the information available in the literature for healthcare staff on the administration of drugs subcutaneously in palliative care patients of the Hospital Unit of home. METHOD: It is designed a summary table of drugs likely to be administered subcutaneously in palliative care patients through the revision of the technical reports of the manufacturers and other literature published by scientific organizations, in addition to the literature search on Pubmed® and Micromedex®. RESULTS: We have reviewed 65 drugs and a guide has been developed of recommendations depending on whether there is information of his administration by subcutaneous or, if on the contrary, its use is contraindicated. CONCLUSIONS: Although mainly manufacturers laboratories do not have data, information collected in this guide will allow the management of the subcutaneous route of some of the most commonly used medications in palliative care.

Objetivo: Elaborar una guía que recopile toda la información disponible en la bibliografía para el personal sanitario sobre la administración de medicamentos por vía subcutánea en pacientes de cuidados paliativos de la Unidad de Hospitalización a Domicilio. Método: Se diseña una tabla resumen de fármacos susceptibles de ser administrados por vía subcutánea en pacientes de cuidados paliativos mediante la revisión de los informes técnicos de los laboratorios fabricantes y de otra literatura publicada por organizaciones científicas, además de la búsqueda bibliográfica en Pubmed® y Micromedex®. Resultados: Se han revisado 65 fármacos y se ha elaborado una guía de recomendaciones en función de si existe información de su administración por vía subcutánea o, si por el contrario, esta contraindicado su uso. Conclusiones: Aunque mayoritariamente los laboratorios fabricantes no disponen de datos, la información recopilada en esta guía permitirá el manejo de la vía subcutánea de algunos de los medicamentos más utilizados en cuidados paliativos.

Dose modification of anti-TNF in rheumatoid arthritis and estimated economical impact: a review of observational studies.

Anti-TNF drugs indicated for the treatment of moderate-to-severe active rheumatoid arthritis (RA) presents similar efficacy, safety and potential toxicity profiles, with more than 10 years' treatment experience. Several pharmacoeconomic evaluations had demonstrated their favorable cost-effectiveness profile in RA patients, based on pivotal clinical studies data from different countries and perspectives. However, in clinical practice, individual profiles of patients and drugs leads to dose modifications that may be associated with substantial cost deviations. Here, we further discuss the effect of dose titration of these biological drugs in clinical practice over their RA cost-effectiveness profiles.

Filgrastim use in the emergency department of a Spanish general hospital.

BACKGROUND: Febrile neutropenia is a cause of dose reduction in hematological cancer treatments, with patient risk of infection proportional to duration and severity. In addition, colony-stimulating factors have been shown to be beneficial in a patient subgroup, although they are probably overused in the clinical setting. OBJECTIVE: Evaluation of compliance with American Society of Clinical Oncology 2006 criteria when it comes to filgrastim use in the Emergency Department of a Spanish general hospital. METHODS AND MATERIALS: A prospective observational study from August 2011 to February 2012 in a tertiary Spanish General Hospital. We included all patients prescribed with filgrastim in the Emergency Department. Data was collected on demographics, the pharmacotherapy history, the administered chemoprophylaxis, and the destination after discharge from a clinical department, the complete blood count, and the presence of fever >= 38 °C. RESULTS: 51 patients were recorded over the period of the study. 27.45% of prescriptions complied with the clinical practice guideline criteria given the risk of febrile neutropenia, whereas 72.34% of prescriptions did not comply with the criteria, 17.65% of which did not fulfil any requirements. CONCLUSIONS: A high percentage of colony-stimulating factors use in the Emergency Department does not comply with the medical practice guideline.

Adverse cutaneous reactions induced by TNF-alpha antagonist therapy.

OBJECTIVE: To review adverse cutaneous drug reactions induced by tumor necrosis factor alpha (TNF-alpha) antagonist therapy. METHODS: A literature search was performed using PubMed (1996-March 2009), EMBASE, and selected MEDLINE Ovid bibliography searches. All language clinical trial data, case reports, letters, and review articles identified from the data sources were used. RESULTS: Since the introduction of TNF-alpha antagonist, the incidence of adverse cutaneous drug reactions has increased significantly. A wide range of different skin lesions might occur during TNF-alpha antagonist treatment. New onset or exacerbation of psoriasis has been reported in patients treated with TNF-alpha antagonists for a variety of rheumatologic conditions. TNF-alpha antagonist therapy has been associated with a lupus-like syndrome; most of these case reports occurred in patients receiving either etanercept or infliximab. Serious skin reactions such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely with the use of TNF-alpha antagonists. CONCLUSIONS: As the use of TNF-alpha antagonists continues to increase, the diagnosis and management of cutaneous side effects will become an increasingly important challenge. In patients receiving TNF-alpha antagonist treatment, skin disease should be considered, and clinicians need to be aware of the adverse reactions of these drugs.

Successful treatment of severe gastrointestinal bleeding secondary to Crohn disease with recombinant factor VIIa.

A 58-year-old man diagnosed with ileocolonic Crohn disease was admitted to the emergency room with massive lower gastrointestinal hemorrhage and hypovolemic shock. Treatment was started with methylprednisolone, metronidazole and omeprazole. Within the next 24 hours, he received a total of 9 U of red blood cell concentrate and 2 U of fresh frozen plasma. Because of persistence of bleeding, hypovolemic shock and life-threatening situation, we started therapy with rFVIIa. One dose of 120 microg/kg and another dose of 120 microg/kg three hours after the first dose were administered as compassionate use, with resolution of bleeding in the next 12 hours. On day 4 the patient was stabilized. We performed a total colonoscopy and intubation of the ileocecal valve that showed patchy deep ulcerations in the rectum with bleeding inflammatory pseudopolyps. Acute gastrointestinal bleeding is an unusual complication in Crohn disease. In this case, the use of recombinant activated factor VIIa controlled the massive gastrointestinal bleeding secondary to Crohn disease and without clinically significant adverse effect. There are few case reports documenting the use of recombinant activated factor VIIa for this type of off-label indication. Clinical trials should be carried out to define the dosage and dose interval schedule of rFVIIa in the treatment of uncontrolled massive gastrointestinal bleeding secondary to Crohn disease.

Optic neuritis with concurrent etanercept and isoniazid therapy.

OBJECTIVE: To report a case of optic neuritis associated with concurrent etanercept and isoniazid therapy. CASE SUMMARY: A 55-year-old man diagnosed as having rheumatoid arthritis had received treatment with nonsteroidal antiinflammatory drugs, sulfasalazine, oral methotrexate, leflunomide, and deflazacort. Four months prior to admission, he had a Disease Activity Score of 6.06; treatment with etanercept was considered. Three months prior to admission, because of evidence of latent tuberculosis, isoniazid 300 mg once daily and pyridoxine 50 mg once daily were prescribed. Treatment with subcutaneous etanercept 25 mg twice weekly was started 5 days after isoniazid was initiated. Two weeks prior to admission, the patient developed blurred vision in his left eye. Ten days later, his vision worsened and he was hospitalized. The visual acuity in both eyes was 0.7, and a campimetric examination was compatible with optic neuritis. Magnetic resonance imaging of the brain revealed lesions suggesting demyelinating lesions. The clinical course was consistent with bilateral optic neuritis. Etanercept was stopped, and isoniazid was replaced with rifampin 600 mg once daily. The patient was treated with intravenous methylprednisolone hemisuccinate 1 g/day for 5 days followed by oral prednisolone, resulting in a minor subjective improvement in left eye visual acuity. He then received oral prednisone for 3 weeks, slowly tapering to discontinuation. DISCUSSION: No physiologic factors could have predisposed this patient to develop optic neuritis. He was not diagnosed with a demyelinating disease or underlying systemic condition. The optic neuritis was unlikely to be an early manifestation of multiple sclerosis based on the clinical course and the negative results of the imaging tests. Furthermore, there was a close temporal correlation between the drug exposure and the onset of symptoms. After discontinuation of etanercept and isoniazid therapy, the patient's general condition improved. Use of the Naranjo probability scale indicated a possible relationship between optic neuritis and combined etanercept-isoniazid therapy. CONCLUSIONS: Patients initiated on etanercept and isoniazid should be closely monitored for the development of adverse neurologic signs and effects. If optic neuritis is determined, etanercept and isoniazid should be discontinued immediately.

Recombinant factor VIIa is an effective therapy for abdominal surgery and severe thrombocytopenia: a case report.

A 50-year-old woman was admitted to the emergency room. An appendectomy was done. On the sixth day the patient's general state deteriorated and she became somnolent with jaundice due to distal obstructive choledocholithiasis. The results of laboratory tests were platelets 12 x 10(9)/L, prothrombin time 13 seconds, international normalized ratio 1.19, activated partial thromboplastin time 31.8 seconds, and fibrinogen 8.78 g/L. There was no evidence of disseminated intravascular coagulation. In view of the patient's clinical condition, surgery was considered to be indicated. Because it was a life-threatening situation and at the time there was no platelet concentrate available for immediate transfusion, she was treated with a single dose of recombinant factor VIIa (rFVIIa) (60 microg/kg). The dose of 60 microg/kg was selected on the basis of experience with rFVIIa in the treatment of hemophilic patients. In this case, use of rFVIIa was a valid alternative to control the bleeding in a patient with thrombocytopenia. However, despite the efficacy of the treatment, it should not be forgotten that it was used because of the unavailability of platelets and that we were dealing with a life-threatening situation. Clinical trials should be carried out to verify the safety, effectiveness, and efficiency of rFVIIa in these cases.

Acenocoumarol-induced Henoch-Schönlein purpura.

OBJECTIVE: To report a probable case of Henoch-Schönlein purpura associated with acenocoumarol therapy. CASE SUMMARY: A 76-year-old white woman was prescribed acenocoumarol for chronic atrial fibrillation. Two months after starting therapy, the patient came to our hospital's emergency department because of abdominal pain associated with vomiting. Physical examination revealed multiple round, confluent, purpuric lesions with some vesicles and an area of residual pigmentation. Lesions were present predominantly on the legs and gluteus, and also on the abdomen and arms. Skin biopsy of the lesions was compatible with leukocytoclastic vasculitis with deposition of immunoglobulin A. An upper intestinal endoscopy was done and identified purpuric mucosal lesions in the fundus, body, and antrum of the stomach and the duodenal bulb. Renal function was not affected, although proteinuria (1.26 g/day) was found and microscopic hematuria was observed. DISCUSSION: The most likely cause of the Henoch-Schönlein purpura in this case was considered to be acenocoumarol because of the close temporal relationship between exposure to the drug and onset of symptoms, as well as the rapid resolution of the symptoms and signs after acenocoumarol was discontinued. The oral anticoagulant was the only identifiable precipitant that the patient encountered before the Henoch-Schönlein purpura developed. An objective causality assessment revealed that the adverse drug event was probable. CONCLUSIONS: This case report illustrates a probable association between Henoch-Schönlein purpura and acenocoumarol. As of December 2003, this reaction had not been previously reported. Clinicians should be aware of this potential adverse effect of a widely used drug.

Photo-induced Stevens-Johnson syndrome due to sulfasalazine therapy.

OBJECTIVE: To report a case of photo-induced Stevens-Johnson Syndrome (SJS) due to sulfasalazine therapy. CASE SUMMARY: Photo-induced SJS associated with sulfasalazine therapy occurred in a 34-year-old white man diagnosed as having seronegative symmetrical polyarthritis with no predisposing factors. According to his medical record, the patient had received methotrexate, levofolinate calcium, deflazacort, and diclofenac sodium as needed. Two months prior to admission, methotrexate and diclofenac sodium were suspended and treatment with sulfasalazine was started. The patient presented to our emergency department because of severe erythema confined to sun-exposed areas; annular lesions on the extremities and the mucosa were affected. Nikolsky's sign was present. A skin biopsy was compatible with SJS, and the clinical diagnosis was SJS induced by sulfasalazine. Administration of sulfasalazine was suspended, which resulted in an improvement in the skin lesions and general state of health. The patient was discharged without further symptoms. DISCUSSION: The observed reaction to sulfasalazine was considered phototoxic, as lesions appeared like a burn rash reaction in sun-exposed areas when sulfasalazine treatment was started and the reaction progressed to SJS. It seems that there was a correlation between the time course of the reaction and the administration of sulfasalazine. An objective causality assessment revealed that the adverse effect was possible. CONCLUSIONS: To our knowledge, this is the first report of photo-induced SJS due to sulfasalazine therapy. Clinicians should be aware of this infrequent but severe reaction. If clinical evaluation leads to the suspicion of SJS, sulfasalazine should be discontinued immediately.