Volume 7 | Issue 12
Lawrence F. Eichenﬁeld MD, Marge Nighland BS, Ana Beatris Rossi MD, Fran Cook-Bolden MD, Pearl Grimes MD, Richard Fried MD PhD, Sharon Levy, PUMP Study Group
It is well known that the setting of clinical trials for registration studies do not necessarily represent efﬁcacy seen in clinical practice,
where physicians have the ﬂexibility to select, combine, and change the acne treatment prescription. In this phase 4, open-label,
multicenter, community-based study, 544 patients who were dissatisﬁed with their current acne treatment received tretinoin gel mi-
crosphere (TGM) 0.04% or 0.1% in a pump dispenser for 12 weeks. Patients were allowed the use of up to 2 other concurrent acne
therapies, not including other retinoids. A total of 361 patients received TGM 0.04% and 183 received TGM 0.1%. Compliance was
high (deﬁned as 75% to 100% of prescribed doses taken) for approximately 95% of patients in both groups at every evaluation. At
week 12, the mean modiﬁed Global Acne Grade score (mGAGs) and the investigator global evaluation (IGE) demonstrated signiﬁcant
(P<.0001) improvement from baseline for both concentrations, with 72% having at least moderate improvement. In approximately
25% of patients, acne was assessed as cleared or almost cleared. Most side effects were characteristic of topical retinoids. These
results indicate TGM in a pump dispenser as an effective, well-tolerated acne treatment that is associated with a high rate of compli-
Alan Menter MD, Kristian Reich MD, Alice B. Gottlieb MD PhD, Mohan Bala PhD, Shu Li MS, Ming-Chun Hsu PhD, Cynthia Guzzo MD, Joris Diels MSc, Joel M. Gelfand MD MSCE
Introduction: Inﬂiximab is indicated for severe plaque psoriasis (PsO). The investigators compared safety event rates in inﬂiximab PsO
trials with those of the general United States and PsO populations.
Methods: Integrated data (n=1373 patients) were compared with external databases.
Results: The analyses reported here are based on 1106 patient years and 116 patient years of follow-up in the inﬂiximab group and the
placebo group, respectively. The standardized mortality ratio in inﬂiximab-treated patients (0.17 [95% conﬁdence interval [CI]: 0.00-0.92],
1 patient died) was lower than that of the general PsO population. No death occurred in the placebo group. Comparing with the psoriasis
population, the standardized incidence ratios (SIRs) for hospitalization were 1.16 (95%CI: 0.92-1.43) in inﬂiximab-treated patients and 1.07
(95%CI: 0.46-2.11) in placebo-treated patients. For serious infection, the SIRs were 1.28 (95%CI: 0.78-1.97) in inﬂiximab-treated patients
and 1.47 (95% CI: 0.18-5.32) in placebo patients. The incidence of tuberculosis (TB) among inﬂiximab-treated patients was 0.18 per 100 pa-
tient-years (95% CI: 0.02-0.65). No TB occurred in the placebo group. Standardized incidence ratio for malignancy (excluding nonmelanoma
skin cancers) was 0.39 (95% CI: 0.05-1.42; 2 malignancies) in inﬂiximab-treated patients. No malignancy occurred in the placebo group.
Limitations: Exclusion criteria in clinical studies may bias selection of subjects who are healthier than the general population. Additionally,
the limited number of patients followed over a maximum of 1 year can limit the ability to detect infrequent events or those events that
require prolonged follow-up to detect. Nonmelanoma skin cancers were excluded from the analysis. Finally, populations and adverse event
deﬁnitions may have differed in external databases and studies.
Conclusion: Based on the data from external databases, mortality, hospitalization, and serious infection rates in inﬂiximab-treated patients
were generally comparable to or less than that of the PsO population. Internal malignancy rates were similar to that expected in the general
US population. However, the limitations of these data must be considered when compared with the totality of the safety proﬁle of inﬂix-
imab generated across all indications.
Parviz Toossi MD, Mehdi Farshchian MD, Farhad Malekzad MD, Nahid Mohtasham MD, Arash Kimyai-Asadi MD
Background: Acne is a common inﬂammatory skin disorder. Oral antibiotics play a signiﬁcant clinical role in treating acne.
Objective: The purpose of this study was to compare the efﬁcacy of doxycycline at antimicrobial and subantimicrobial doses for the
treatment of acne.
Methods: A prospective, randomized, double-blind, controlled trial was performed. One hundred patients with moderate facial acne
were randomized into 2 treatment groups, one receiving a tablet containing 20 mg of doxycycline to be taken twice daily and the
other receiving a tablet containing 100 mg of doxycycline and a matching placebo tablet to be taken twice daily.
Results: Subantimicrobial-dose doxycycline administered twice daily for 3 months in patients with moderate inﬂammatory acne
results in signiﬁcant reduction in the number of total inﬂammatory lesions. There was an 84% reduction in number of papules and a
90% reduction in number of pustules with treatment.
Conclusion: Subantimicrobial-dose doxycycline is an effective treatment for patients with moderate acne vulgaris.
William Abramovits MD, Alan B. Fleischer Jr MD, Eileen Jaracz Pharm D, Debra Breneman MD
The objective of this study was to compare the efﬁ cacy and safety of tacrolimus ointment and pimecrolimus cream in adults with
moderate atopic dermatitis (AD). A randomized, investigator-blinded, 6-week, multicenter study enrolled patients (≥16 years) with
mild to very severe AD. Patients with moderate AD at baseline were analyzed. At study completion, tacrolimus ointment-treated
patients had signiﬁ cantly greater improvement in Eczema Area Severity Index score compared with pimecrolimus cream-treated pa-
tients (59% versus. 43% reduction, respectively; P=.01). Signiﬁ cantly more tacrolimus ointment-treated patients than pimecrolimus
cream-treated patients improved by 1 or more grades on the Investigators’ Global Atopic Dermatitis Assessment (P<.02). A total of
5 pimecrolimus cream-treated patients discontinued the study early due to lack of efﬁ cacy compared with no tacrolimus ointment-
treated patients (P=.02). Overall, reported adverse events occurred at a similar frequency for both treatment groups. Tacrolimus
ointment is more effective than pimecrolimus cream in the management of adults with moderate AD.
No abstract details for the moment.
Tracy M. Campbell MD, Clarence W. Brown Jr MD
The epidermal growth factor receptor (EGFR) inhibitor class of agents have been reported to cause multiple cutaneous adverse
events. These drug eruptions are thought by some to indicate a good prognosis. The authors report of a case of a psoriasiform scalp
eruption simultaneously occurring with an acneiform or follicular rash in a single patient. To present knowledge, this is the ﬁrst report
of a psoriasiform eruption triggered by erlotinib. In addition, this case report demonstrates 2 completely distinct cutaneous morpholo-
gies occurring simultaneously with erlotinib therapy in a single patient.
Kristin Noiles BSc, Ronald Vender MD FRCPC
Background: Psoriasis of the skin is in itself a disturbing disorder both physically and psychologically. However, most often the scaly
plaques can be hidden by clothing. When psoriasis involves the face it can be more disabling and can decrease the patient’s quality of
life. Facial psoriasis is difﬁcult to treat and is associated with severe cutaneous disease. Patients who have a long duration of psoriasis
or early age of onset are more likely to suffer from facial involvement. Facial psoriasis may also be associated with pruritus, psoriatic
arthritis, and with a family history of psoriasis.
Objective: The authors report a case of a female patient with psoriasis with severe cutaneous disease and extensive facial involvement
successfully treated with adalimumab. This 50-year-old Caucasian female had a history of cutaneous psoriasis since 1990 and psoriatic
arthritis since 2005. The patient had associated pruritus and a family history (maternal). Systematic treatment with mycophenolate
mofetil and acitretin proved unsuccessful. The patient also lost efﬁcacy after months of ultraviolet light B and topical psoralen plus
ultraviolet light A phototherapy.
Results: In 2007, the patient was screened and initiated therapy with a monoclonal humanized tumor necrosis factor alpha inhibitor,
adalimumab. She had severe facial and body involvement with a body surface area of 25%, a Psoriasis Area and Severity Index of
20.4 (PASI), and a head and neck psoriasis area and severity index (HNPASI) of 3.6. Photographic documentation was carried out
with improvement noted as soon as 4 weeks with continuing signiﬁcant response thereafter. No adverse effects were noted. The
patient’s quality of life also improved.
Limitations: Although severe facial psoriasis is rare and associated with only the most extensive and severe psoriatic cases, it is
likely the most psychologically disturbing and cosmetically disrupting to the patient because it cannot easily be covered or concealed.
The authors hope this case can illustrate an excellent therapeutic option for these patients.
Conclusion: Although facial psoriasis is difﬁcult to treat, with newer systemic therapy now available in the form of biologics, patients
now have a hope for this disease, especially devastating when associated with severe and extensive cutaneous involvement. The
case gives promise in a serial photo-documented fashion of the success that can be achieved.
Natalie Reytan MD, Berthold Rzany MD ScM
Background: Facial lipoatrophy is a common problem for patients with human immunodeﬁ ciency virus (HIV) treated with highly active
antiretroviral therapy (HAART). The loss of subcutaneous facial tissue occurs in the cheeks, temples, and periocular region. Facial lipoa-
trophy is a stigmatizing feature of HIV. The effective treatment can provide psychosocial stress for the patient.
Objective: To report on the experience using a ribose-crosslinked collagen ﬁ ller in the treatment of a patient with HIV-associated facial
lipoatrophy. Physician observations and photographs for documentation were collected up to 14 months posttreatment.
Methods: A patient with HIV with facial lipoatrophy was treated with the ribose-crosslinked collagen injectable ﬁ ller derived from por-
Results: After 4 treatment sessions over 7 months signiﬁ cant improvement was found and dermal thickening was retained in the area
of the cheeks for an additional 7 months.
Conclusion: As facial lipoatrophy is a very stigmatizing manifestation of HIV, volume augmentation is highly beneﬁ cial. By using a ribose-
crosslinked collagen, a very natural outcome was obtained that lasted for over 7 months. Additional studies should be conducted to
further investigate the use of this ﬁ ller in the treatment of HIV-associated facial lipoatrophy.
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