PD03—MEDICAL DERMATOLOGY Patient geography and relation to dermatology service utilization
(Poster reference number 5606)
Advancing pharmacovigilance through analysis of a gadolinium-based
contrast agent (GBCA) exposure dataset for nephrogenic systemic fibrosis:
A RADAR report
(Poster reference number 5325)
Beatrice Nardone, MD, PhD, Department of Dermatology, Northwestern
University, Chicago, IL, United States; Anne E. Laumann, MBChB, Department
of Dermatology, Northwestern University, Chicago, IL, United States; Beatrice J.
Edwards, MD, MPH, Department of Medicine, Division of Geriatrics,
Northwestern University, Chicago, IL, United States; Dennis P. West, PhD,
Department of Dermatology, Northwestern University, Chicago, IL, United
States; Steven M. Belknap, MD, Department of Dermatology, Northwestern
University, Chicago, IL, United States
Background: Nephrogenic systemic fibrosis (NSF) is a systemic fibrosing disorder
primarily affecting patients with end-stage renal disease (ESRD). Patients develop
progressive, indurated plaques and confluent papules on their skin, visceral fibrosis,
contractures, and may proceed to disability and elevated mortality. NSF is associated
with systemic exposure to gadolinium-based contrast agents (GBCAs). Higher GBCA
doses and/or cumulative dosing may raise the risk of NSF.
Methods: RADAR (Research on Adverse Drug events And Reports) searched a GBCA-
exposure dataset for NSF biopsy-proven cases, all with GBCA exposures and
positively identified as linked to a specific product (good faith substantiation). Cases
were characterized as unconfounded if it was determined that the patient was
exposed to only one GBCA before NSF diagnosis and confounded if the patient was
exposed to two or more GBCAs. The cases in this publicly available dataset are those
filed in federal court within the Gadolinium-Based Contrast Agents Product Liability
Litigation, MDL No. 1909.
Results: A total of 382 individual biopsy-proven, product-specific NSF cases were
analyzed. 76.1% (291/382) identified exposure to gadodiamide, of which 67.7%
(197/291) were unconfounded. In addition, 40% (153/382) of cases involved
gadopentetate dimeglumine, of which 48.3% (74/153) were unconfounded while
gadoversetamide was identified in 7.3% (28/382) of which 28.6% (8/28) were
uncounfounded. Some cases involved gadobenate dimeglumine or gadoteridol, 5.7%
(22/382) all of which were confounded. The mean number of exposures to GBCA
was gadodiamide (3), gadopentetate dimeglumine (5) and gadoversetamide (2). Of
the 279 uncounfounded cases, all involved a linear-structured GBCA. Two hundred
and five (73.5%) were a nonionic GBCA while 74 (26.5%) were an ionic GBCA.
Conclusion: High GBCA dose, low patient renal function, presence of systemic
inflammation and chemical instability of the gadolinium-chelate are likely to be the
key determinants for NSF. Importantly, this publicly available legal dataset allows for
the identification of unconfounded cases with product-specific exposure
information.
Commercial support: None identified.
Skin manifestations of outpatient adverse drug events in the United States:
A national analysis
(Poster reference number 5560)
Peter Koelblinger, Wake Forest University School of Medicine, Winston Salem,
NC, United States; Scott Davis, Wake Forest University School of Medicine,
Winston Salem, NC, United States; Steve Feldman, MD, PhD, Wake Forest
University School of Medicine, Winston Salem, NC, United States; Tushar
Dabade, MD, Wake Forest University School of Medicine, Winston Salem, NC,
United States
Background: Cutaneous reactions to drugs are among the most common clinical
manifestation of adverse drug events (ADEs); however, data on outpatient cutaneous
adverse drug events (CADEs) are limited.
Purpose: To provide national estimates of outpatient CADEs and determine their
most frequent causes.
Methods: Outpatient CADEs recorded in the National Ambulatory Medical Care
Survey (NAMCS) and the National Hospital and Ambulatory Medical Care Survey
(NHAMCS) between 1995 and 2005 were analyzed. By applying sampling weights,
the national annual incidence of outpatient CADEs in the United States was
estimated and the most frequent medication classes implicated with CADEs were
identified.
Results: Our analysis yielded a mean annual total of 635,982 CADE-related visits,
resulting in an annual incidence of 2.26 CADEs per 1,000 persons. Patients took an
average of 2.2 medications in addition to the one causing the CADE. The incidence
of CADEs increased with age, with a peak in the age group from 70-79 years. The
medications most frequently causing a CADE were antimicrobial agents, with
amoxicillin being the most frequent single causative substance. Dermatitis and
urticaria were the two main types of skin reactions reported. Limitations: Estimates
were limited by the sample size of 539 visit records. Conclusions: CADEs occur less
frequently in outpatients than for inpatients, and result in fewer hospital admissions
than ADEs in general (1.2 vs 2.5%). Physicians must be particularly cognizant of the
occurrence of CADEs when prescribing antimicrobial agents.
Commercial support: None identified.
APRIL 2012
Elaine Dupuis, University of British Columbia, Vancouver, Canada; Wingfield
Rehmus, MD, MPH, University of British Columbia, Vancouver, Canada
Background: In many Canadian provinces, dermatologists are unevenly distributed.
Literature supports that patients in and near urban centers have the shortest travel
distance to a dermatologist. Patients living at a great distance from a dermatologist
might be referred less often for management of less severe skin problems because of
the cost of travel and relative inaccessibility of specialty care. This study set out to (a)
identify the top diagnoses seen at BC Children’s Hospital (BCCH) dermatology
clinic, (b) examine if diagnoses differ based on where the patient lives, and (c)
explore what relationship exists between distance from patient’s home to BCCH
dermatology clinic and disease severity. We hypothesize that the further a patient
travels to see a dermatologist, then the more severe their disease.
Methods: A list of all new patient visits to BCCH dermatology clinic during 2009 was
compiled and sorted by ICD-10 codes to produce a ranking list of encountered
diagnoses. For each diagnosis, data were subsequently sorted by health region,
delivery area, and city of residence. Census data and definitions were used to classify
cases as urban or rural. For each health area, the most common reasons for referral to
dermatology were noted. For acne and atopic dermatitis cases, a retrospective chart
review was undertaken to assess disease severity based on patient management.
Patient demographics, primary reason for visit, prescribed treatment and follow-up
care were noted.
Results: The top 10 diagnoses at the BCCH dermatology clinic were: atopic
dermatitis (2102 cases), hemangioma (289), acne (263), psoriasis (145), warts
(121), congenital nevi (97), molluscum contagiosum (95), eczema, NEC (78), vitiligo
(77), and alopecia areata (60). The most common reasons for referral to the
dermatology clinic were comparable between health regions despite vast differ-
ences in geographic proximity to the clinic. The majority of patients were from
urban areas. Only 0.1% of all cases for atopic dermatitis and 5.4% of all acne cases
were from rural areas.
Conclusion: The results suggest that the most frequent cases seen at BCCH
dermatology clinic are common diagnoses, even for patients who come from a
great distance to the clinic. This suggests that educational programs for primary care
doctors in other areas in British Columbia should focus on management of these
common skin conditions. Complete results including chart review for disease
severity will be presented.
Commercial support: None identified.
Value of omalizumab in chronic refractory urticaria
(Poster reference number 4738)
Miquel Armengot-Carbo, MD, Arnau de Vilanova Hospital, Valencia, Spain;
Beatriz Rodrigo-Nicolas, MD, Arnau de Vilanova Hospital, Valencia, Spain;
Enrique Gimeno Carpio, MD, Arnau de Vilanova Hospital, Valencia, Spain;
Manuel Velasco Pastor, MD, PhD, Arnau de Vilanova Hospital, Valencia, Spain;
Virginia Pont Sanjuan, MD, Arnau de Vilanova Hospital, Valencia, Spain
Background: Omalizumab is a monoclonal anti-IgE antibody approved for the
treatment of severe allergic asthma. Several cases have been published in the
literature, and there are some small series where it was used successfully for the
treatment of both autoimmune and nonautoimmune chronic urticaria (CU).
Purpose: We performed a review of the patients treated in our department with
omalizumab for the purpose of evaluating its efficacy in refractory CU.
Methods: A retrospective case review was performed over 15 patients with CU that
started treatment with omalizumab during the year 2010. Their medical records
were reviewed to evaluate the improvement obtained at 3 and 6 months of
treatment. For this retrospective assessment, the response obtained was classified as
follows: lack of response, mild response (symptom improvement with no reduction
of previous treatments), moderate response (symptom improvement with reduc-
tion of previous treatments), and complete response (asymptomatic with no other
added treatment).
Results: The mean duration of the clinical symptoms was 6 years (range, 6 months to
22 years). All patients were refractory to antihistamines and some were also to
corticoids and/or cyclosporine. After 3 months of treatment, 12 of the 15 patients
(80%) obtained some type of response. Three patients (20%) obtained a complete
response, 7 (47%) a moderate response, 2 (13%) a mild response, and 3 (20%) had no
response. Of nonresponders, two discontinued treatment; the dose was increased in
one; and one patient with moderate response discontinued for work reasons. The
drug was removed in two patients with complete response and they experienced
clinical relapse after 5 weeks, so omalizumab was restarted, obtaining again a
complete response (persistent after 2 months follow-up). Six-month data are
available for 10 patients: eight had obtained or maintained a complete response,
and two had a mild response. None of those obtaining response at 3 months lost
efficacy at 6 months.
Conclusion: Although further studies supporting it are required, the results obtained
in our series show that omalizumab is an effective therapeutic tool in cases of
chronic urticaria not responding to conventional treatments.
Commercial support: None identified.
J AM ACAD DERMATOL AB5