Changes in C-reactive protein in patients with moderate-to-severe psoriasis switched to adalimumab therapy after suboptimal response to etanercept, methotrexate or phototherapy.

BACKGROUND: Psoriasis treatment can lower levels of the inflammatory biomarker C-reactive protein (CRP). OBJECTIVE: Evaluate CRP changes in patients with chronic plaque psoriasis who switched to adalimumab following suboptimal response to previous therapies. METHODS: C-reactive protein was measured at screening and after 16 weeks of adalimumab treatment following discontinuation of previous therapies: etanercept (substudy E; n = 77), methotrexate (substudy M; n = 38) or narrow-band ultraviolet B phototherapy (substudy P; n = 27). Associations of CRP with baseline characteristics and efficacy measures were evaluated. RESULTS: Median CRP change at the final visit was -0.3 mg/L overall and -0.4, -0.3 and -0.3 mg/L in substudies E, M and P respectively. Clinical response [Physician Global Assessment (PGA) 'clear' or 'minimal'] was associated with greater CRP reductions vs. no response (PGA 'mild' or worse) overall (-0.4 vs. -0.3 mg/L) and in substudies E (-0.4 vs. -0.1 mg/L) and M (-0.5 vs. -0.2 mg/L), but not P (-0.1 vs. -0.4 mg/L). CRP decreases were, respectively, -0.4 and -0.3 mg/L in patients with and without a history of psoriatic arthritis and -0.1, -0.3 and -0.6 mg/L in normal weight, overweight and obese patients, respectively. CRP decreases after 16 weeks correlated positively (ß = 0.004) with percentage change in Psoriasis Area and Severity Index (PASI; P = 0.0398) and negatively (ß = -0.360) with baseline CRP (P < 0.0001). CONCLUSION: C-reactive protein levels decreased during adalimumab therapy in patients with psoriasis who experienced suboptimal response to previous therapies. Clinical response was associated with greater CRP reductions overall and in substudies E and M, but not P. CRP reductions correlated with percentage reductions in PASI.

Efficacy of adalimumab across subgroups of patients with moderate-to-severe chronic plaque psoriasis of the hands and/or feet: post hoc analysis of REACH.

BACKGROUND: The Randomized Controlled Evaluation of Adalimumab in Treatment of Chronic Plaque Psoriasis of the Hands and Feet (REACH) trial demonstrated that adalimumab was efficacious and well-tolerated for the treatment of hand and/or foot psoriasis through 28 weeks. OBJECTIVE: To evaluate the effects of patient baseline characteristics on efficacy of adalimumab treatment of hand and/or foot psoriasis. METHODS: Patients with moderate-to-severe chronic plaque psoriasis of the hands and/or feet were randomized 2 : 1 to adalimumab or placebo during the 16 week, double-blind period of REACH. Primary endpoint was percentage of patients achieving Physician's Global Assessment of the hands and/or feet of clear/almost clear at week 16. Post hoc analyses evaluated effects of baseline patient characteristics on the primary endpoint. Patients with nail psoriasis at baseline were assessed for association of Nail Psoriasis Severity Index (NAPSI) 50 response with efficacy outcomes at week 16. RESULTS: Seventy-two patients (49 adalimumab : 23 placebo) were analysed. Greater percentages of adalimumab-treated patients achieved the primary endpoint vs. placebo across all subgroups. Among 31 patients with nail psoriasis, a greater percentage of adalimumab-treated patients achieved NAPSI 50 (56.5%) vs. placebo (12.5%) at week 16. In adalimumab-treated patients, greater percentages of NAPSI 50 Responders vs. Non-responders achieved the primary endpoint, and had greater improvements in erythema, scaling, induration and fissuring, Dermatology Life Quality Index, and pain scores. CONCLUSIONS: Adalimumab was efficacious in treating chronic plaque psoriasis of the hands and/or feet over 16 weeks, regardless of baseline characteristics. Marked improvement in nail psoriasis among adalimumab-treated patients correlated with significant improvements in skin disease and patient-reported outcomes.

Using personal digital assistants to enhance outcomes.

Personal digital assistants (PDA) are attaining increased functionality in the medical community. Physicians can use PDAs to track patient information (namely, outcome parameters and medication errors). ePhysician's ePad is demonstrated here as a successful technology for tracking and analyzing both patient and practice data.

Electronic prescribing: criteria for evaluating handheld prescribing systems and an evaluation of a new, handheld, wireless wide area network (WWAN) prescribing system.

OBJECTIVE: The objectives of this study were: 1) to establish criteria for evaluating handheld computerized prescribing systems; and 2) to evaluate out-of-box performance and features of a new, Palm Operating System (OS)-based, handheld, wireless wide area network (WWAN) prescribing system. The system consisted of a Palm Vx handheld organizer, a Novatel Minstrel V wireless modem, OmniSky wireless internet access and ePhysician ePad 1.1, the Palm OS electronic prescribing software program. DESIGN: A dermatologist familiar with healthcare information technology conducted an evaluation of the performance and features of a new, handheld, WWAN electronic prescribing system in an office practice during a three-month period in 2000. System performance, defined as transmission success rate, was determined from data collected during the three-month trial. Evaluation criteria consisted of an analysis of features found in electronic prescribing systems. METHODS: All prescriptions written for all patients seen during a three-month period (August - November, 2000) were eligible for inclusion. Prescriptions written for patients who intended to fill them at pharmacies without known facsimile receiving capabilities were excluded from the study. The performance of the system was evaluated using data collected during the study. Criteria for evaluating features of electronic prescribing systems were developed and used to analyze the system employed in this study. RESULTS: During this three-month trial, 200 electronic prescriptions were generated for 132 patients included in the study. Of these prescriptions, 92.5 percent were successfully transmitted to pharmacies. Transmission failures resulted from incorrect facsimile numbers and non-functioning facsimile machines. Criteria established for evaluation of electronic prescribing systems included System (Hardware & Software), Costs, System Features, Printing & Transmission, Formulary & Insurance, Customization, Drug Safety and Security. CONCLUSION: This study is the first effort to establish comprehensive criteria for evaluating handheld prescribing systems and to evaluate the performance and features of a handheld, electronic prescribing system. The results demonstrated that the evaluated system: 1) was simple to install; 2) successfully interfaced with a commonly used practice management system; 3) was user-friendly and easy to operate; 4) offered a robust variety of standard features; and, 5) resulted in a high rate of success for transmitting electronic prescriptions. The criteria established for the evaluation of features of an electronic prescribing system can be used to critically evaluate the performance and features of other handheld and personal computer-based electronic prescribing systems.

Neonatal citrullinemia associated with cutaneous manifestations and arginine deficiency.

A patient with neonatal citrullinemia (argininosuccinic acid synthetase deficiency), a heritable disorder of the urea cycle, developed a generalized cutaneous eruption at 35 days of age. The skin lesions consisted of erosive, erythematous, scaling patches and plaques. The plasma arginine concentration at that time was low. After treatment with oral arginine supplements, the cutaneous lesions rapidly resolved and the plasma arginine concentration normalized. Histologic features of pretreated lesions included parakeratosis, crust formation, absence of a granular cell layer, pallor of the upper epidermal cells, and a mild, superficial, perivascular, mononuclear-cell infiltrate. Since the patient's skin lesions responded to arginine supplements, and since arginine is a component of keratin, we postulate that the skin lesions are the result of arginine deficiency.

Pseudo-Kaposi's sarcoma of the hand associated with an acquired, iatrogenic arteriovenous fistula.

Pseudo-Kaposi's sarcoma has been associated, in most cases, with an underlying congenital arteriovenous (AV) fistula. A patient with chronic renal failure and an acquired, iatrogenic AV fistula in his left wrist for hemodialysis developed pseudo-Kaposi's sarcoma on his left hand three years after placement of the AV fistula. Histologic findings included a proliferation of superficial dermal vessels and fibroblasts, extravasated red blood cells, and occasional fibrin thrombi in vessels. To our knowledge, this is the third case of an association between pseudo-Kaposi's sarcoma and an acquired, iatrogenic AV fistula, and the first to involve the hand. Pseudo-Kaposi's sarcoma occurs in association with underlying congenital and acquired AV fistulas.

Dimethyl sulfoxide (DMSO) does not affect epidermal wound healing.

We studied the effect of 95% DMSO on dermal/epidermal healing and microbiol flora in partial-thickness wounds. Wounds of 0.3 mm were made in the skin of Yorkshire pigs with a keratome and treated daily with either 95% DMSO, water, or they were left untreated. Wounds were excised on Days 2-7 and the dermis was separated from the epidermis. The dermis was assayed for collagen biosynthesis (by measuring the production of [14C]hydroxyproline (HP) and amount of radioactive peptides released after collagenase digestion) and absolute HP (by spectrophotometric analysis). The epidermis was evaluated macroscopically for resurfacing. Aerobic bacteria from unwounded and wounded skin were identified and quantitated. There were no significant differences between treatment groups in HP incorporation or absolute collagen content from Days 2-6 after wounding. HP incorporation in the total protein fractions and in the collagenase digestible fractions were analogous. Collagen biosynthesis was similar in both unwounded, untreated, and unwounded DMSO-treated skin. Epidermal healing did not differ between treatment groups. There were no differences in the number or types of bacteria in wounds between treatment groups. These results indicate that topical DMSO is neither beneficial nor harmful in the healing of superficial wounds.

Intragastric feeding in the neonatal dog. Its effect on intestinal osmolality.

Hypertonic formulas have been implicated in the etiology of necrotizing enterocolitis. We measured the osmolality of neonatal canine intestinal contents one hour after intragastric feeding of isotonic breast milk, isotonic formula, or hypertonic formula in 1-day-old and 9-day-old puppies. Regardless of the formula tonicity, all intestinal contents were hypertonic in both segments. Hypertonic formula had been diluted, and isotonic feedings concentrated in the neonatal canine intestine. Gastric contents could be recovered only from hypertonic-fed puppies, which implies delayed gastric emptying to permit formula dilution. We conclude that any form of neonatal feeding can lead to hypertonic intestinal contents. Factors other than tonicity of a formula should be considered in the pathophysiology of necrotizing enterocolitis.