Omalizumab treatment in combination with any other biologics: Is it really a safe duo?

BACKGROUND: Chronic spontaneous urticaria (CSU) is a mast cell-mediated disease, which is sometimes associated with various inflammatory disorders. Omalizumab is a commonly used biological agent, which is a recombinant, humanized, monoclonal antibody against human immunoglobulin E. However, there are only few reports about the combination of omalizumab for CSU with any other biologics for accompanying inflammatory diseases in the literature. The aim of this study was to evaluate the patients whose treatment of omalizumab for CSU were combined with any other biologics for associated inflammatory disorders and to describe whether these combinations might have any safety concerns. METHODS: We conducted a retrospective cohort study of adult patients with CSU treated with omalizumab concurrently using another biological agent for their other dermatological conditions. RESULTS: Thirty-one patients, 19 women and 12 men, were evaluated. The mean age was 45.13 years. The median duration of omalizumab was 11 months. Biological agents which patients were treated other than omalizumab were as follows: adalimumab biosimilar (n = 3), ustekinumab (n = 4), secukinumab (n = 17) and ixekizumab (n = 7). The median duration of concurrent use of omalizumab and other biologics was 8 months. None of the drug combinations was stopped because of side effects. CONCLUSION: This observational study demonstrated that omalizumab treatment for CSU in combination with any other biological agents for dermatological disorders appeared to be well tolerated without any major safety concerns.

Common tongue conditions affect quality of life: an issue to be recognized.

INTRODUCTION: There is an increasing recognition that oral disorders might cause significant impact on life of patients. To date, there has been less focus on oral health-related quality of life (OHR-QoL) measures in outpatient clinics for oral diseases. AIM: This study was carried out to test the assumption that patients with common tongue conditions would report a worse OHR-QoL than controls. METHOD: A total of 59 oral subjects with various tongue conditions and 44 controls were enrolled in this prospective study. Demographic, clinic, and laboratory findings of oral subjects were recorded, and an OHR-QoL questionnaire, named 14-item oral health impact profile (OHIP-14), was completed by oral subjects and controls at the outpatient clinics of four centers. RESULTS: Median of OHIP-14 total scores of the oral subjects with common tongue conditions was 11 and that of controls was 4 (P = 0.00) indicating that OHR-QoL was worse in oral subjects than in controls. Most (n = 39, 66%) of the oral subjects had mild to distressing pain. Eating was the most commonly affected function. Oral subjects were arbitrarily divided into two groups. Group 1 (n = 22) included patients with tongue conditions which were associated with candidal infections and the other patients formed Group 2 (n = 34). A significant difference between Group 1 and Group 2 was observed only with respect to functional limitation (P = 0.027), indicating that oral subjects of Group 1 had more functional limitation. CONCLUSION: Common tongue disorders were believed to be innocuous by most. When the influence of one of the most common form of oral disease (tongue conditions) on OHR-QoL was taken into consideration, OHR-QoL will provide an additional dimension and may help to improve the impact of a disease on an individual's life. Moreover, we also encourage more extensive use of these OHR-QoL instruments for oral diseases at outpatient clinics.

Childhood pityriasis lichenoides and oral erythromycin.

Pityriasis lichenoides (PL) is not uncommon in childhood, but current knowledge about the efficacy of oral erythromycin therapy for its treatment in children is limited. To investigate the role of oral erythromycin therapy in the treatment of PL in children, the records of 24 children with PL who had been started on oral erythromycin treatment at our institution between 2005 and 2008 were retrospectively reviewed. The study included 24 patients (14 male, 10 female) with a median age of 7 years (range 2-14) of whom 15 (62.5%) had PL chronica (PLC), six (25%) PL et varioliformis acuta (PLEVA), and three (2.5%) PLEVA-PLC overlap. History of upper respiratory tract infection was reported in 33% (n = 8) of the patients. History of drug intake and vaccination was noted in 20% (n = 5) and 20% (n = 5), respectively. The disease began during spring (30%, n = 7) or fall (30%, n = 7) in the majority of patients. The median duration of the disease was 11 months (range 1-48 months). Fifteen (68.2%) patients had more than 100 lesions. Distribution was diffuse in 82% (n = 18) of the cases and peripheral in the remainder (n = 6). Oral erythromycin was started at a dosage of 30 to 50 mg/kg per day in three to four divided dosages for 1 to 4 months. Good response was recorded in 64% and 73% of patients in the first and second months of therapy, respectively. Response rate rose to 83% in the third month. In those for whom follow-up data were available (n = 16), relapse was recorded in 12.5% (n = 3). Oral erythromycin may be an effective and well-tolerated treatment option for PL in children and should be continued for at least 3 months.

Infliximab treatment for psoriasis in 120 patients on therapy for a minimum of one year: a review.

Infliximab is a chimeric monoclonal antibody, which acts by binding to both the soluble and membrane-bound tumor necrosis factor-?. In clinical practice, it is used as either monotherapy or in combination with other systemic therapies, particularly methotrexate. This study reviews clinical response and adverse events in 120 psoriasis patients with moderate-to-severe psoriasis who have received infliximab for a minimum of one year. The medical records of 120 infliximab-treated psoriasis patients at our referral psoriasis clinic in Dallas between 2002-2008 were reviewed for response rates, side effects and concomitant therapies. Of 120 charts reviewed, 112 (93%) patients had plaque type psoriasis, six (5%) had recalcitrant palmoplantar disease and two (1.6%) had severe acropustulosis of Hallopeau. Eighty-four (70%) patients had symptomatic psoriatic arthritis. The mean follow-up time was 2.2±1.1 years. One hundred and nine (91%) of the 120 patients had clearance of their psoriasis (response of more than 90% of initial BSA) at a median time of 12 weeks. Concomitant systemic treatments, primarily methotrexate, were given to 62 (52%) patients. Nineteen patients (16%) discontinued infliximab in the post-one-year treatment period for a variety of reasons, primarily failure to maintain adequate response. One hundred and four (87%) of patients required more than the standard dose of 5 mg/kg every eight weeks to maintain clearance. Infliximab either as monotherapy or in combination with traditional antipsoriatic agents is an effective and well-tolerated treatment option for patients with moderate to severe psoriasis and psoriatic arthritis on therapy for over one year and continuing for the long term.

Isotretinoin treatment for folliculitis decalvans: a retrospective case-series study.

BACKGROUND: The literature includes only a few reports of oral isotretinoin for the treatment of folliculitis decalvans (FD). This study aimed to determine the most effective dose and duration of oral isotretinoin monotherapy for achieving remission in FD patients. METHODS: This retrospective case series study included FD patients that were treated with oral isotretinoin. Patient demographics, clinical characteristics, and treatment details were obtained from the patients' medical records. Patients were contacted via telephone after treatment was completed and asked about any relapses, time period of relapses, and the long-term effects of the treatment. RESULTS: The study included 39 male patients with a mean age of 37.9 ± 15.5 years. All of the patients received oral isotretinoin 0.1-1.02 mg/kg/day (10-90 mg/day) for a median duration of 2.5 months (range: 1-8 months). In all, 82.0% of patients healed after the treatment. Patients that received oral isotretinoin ≥0.4 mg/kg/day for ≥3 months responded better, and 66% of them never relapsed. CONCLUSION: Contrary to general belief, oral isotretinoin monotherapy resulted in complete response in the majority of patients in this study. Based on this finding, we think oral isotretinoin ≥0.4 mg/kg/day should be given for ≥3 months to minimize the likelihood of relapse. In addition, we think oral isotretinoin monotherapy should be considered a promising treatment alternative for FD that warrants further research.

Is there a role of food additives in recurrent aphthous stomatitis? A prospective study with patch testing.

BACKGROUND: Recurrent aphthous stomatitis (RAS) is a common disease of the oral mucosa with an unknown etiology. This study aimed to determine if food additives play a role in the etiology of RAS as well as to determine if patch testing can be used to detect which allergens cause RAS. METHODS: This prospective study included 24 patients with RAS and 22 healthy controls. All the participants underwent patch testing for 23 food additives. RESULTS: In total, 21 (87.5%) RAS patients and 3 (13.6%) controls had positive patch test reactions to ≥1 allergens; the difference in the patch test positivity rate between groups was significant (P < 0.05). The most common allergen that elicited positive patch test results in the patient group was cochineal red (n = 15 [62.5%]), followed by azorubine (n = 11 [45.8%]) and amaranth (n = 6 [25%]). CONCLUSIONS: The present findings show that food additives might play a role in the etiology of RAS and that patch testing could be a method for determining the etiology of RAS.

Long-term follow-up of early mycosis fungoides patients treated with narrowband ultraviolet B phototherapy.

BACKGROUND: Narrowband ultraviolet B (UVB) provides complete response (CR) in 54-91% of early mycosis fungoides (MF) patients. Data concerning relapse rate and relapse-free interval after discontinuation of therapy need clarification. The purpose of this study was to evaluate the relapse rate and the relapse-free intervals of early MF patients after achieving complete response with narrowband UVB phototherapy. METHODS: Retrospective evaluation of data, which belong to early MF patients treated with narrowband UVB phototherapy between May 2000 and July 2010, and followed-up until May 2012 in a single institution, for the occurrence of relapse and the time to relapse. RESULTS: Of 31 patients, who were followed-up for a mean of 56.5 ± 30.2 months (median 55 months, range 20-120 months), relapse was observed in 11 (35.5%) patients, within a mean of 28.8 ± 18.2 months (median 33 months, range 4-59 months), whereas 20 (64.5%) patients stayed relapse-free for a mean of 54.2 ± 28.8 months (median 55.5 months, range 20-119 months). Patients received maintenance phototherapy with a median duration of 12 months (range 1-30 months) after achieving complete response. CONCLUSION: Results indicate that narrowband UVB phototherapy may induce low relapse rates and long relapse-free intervals for early MF.

Extremely high parathyroid hormone concentrations associated with pityriasis rubra pilaris and monoclonal gammopathy of unknown significance: a clinical dilemma.

We present a case with extremely high parathyroid hormone (PTH) concentrations in the order of hundred thousands accompanied by dermatological and hematological diseases. After several diagnostic interventions, no malignancy could be demonstrated except monoclonal gammopathy of unknown significance. The dermatological findings were taken to be manifestations of the hematological disease. Since the first serum intact PTH concentration of the patient was found to be higher than 2500 pg/ml, dilution study was performed and found to be 215,977 pg/ml. The high concentration of serum PTH was taken to be falsely high due to assay interference. This concentration was checked from three different paths; a test for linear dilution was performed, the test was repeated with another method and the sample was treated to remove or inhibit interfering substances. The results were compatible with endogenous antibody interference, presumed to be a result of monoclonal gammopathy. The extremely high PTH concentrations were not only due to assay interference, but also secondary hyperparathyroidism, which was evident by the decrease in PTH concentrations with calcium and vitamin D treatments.

Does recurrent aphthous stomatitis affect quality of life? A prospective study with 128 patients evaluating different treatment modalities.

INTRODUCTION: Quality of life measures are increasingly being used in the evaluation of oral disease outcome. To date, there has been less focus on oral health-related quality of life (OHR-QoL) measures for oral diseases in dermatologic literature. OBJECTIVE: To test whether patients with recurrent aphthous stomatitis (RAS) report a lower OHR-QoL than the general population and to evaluate therapeutic regimens for RAS by using OHR-QoL measures. METHOD: A total of 128 patients and 40 controls were enrolled. A questionnaire entitled the 14-item oral health impact profile (OHIP-14) was completed. Forty-three (33%) of the patients were followed-up and completed the OHIP-14 following treatment. RESULTS: The median total score of patients on colchicine before treatment was 21. Following use of colchicine, the total score was 10. There was a significant difference concerning the impact of oral health following use of oral colchicine. However, no reduction of OHIP-14 scores was observed in the topical treatment group. CONCLUSION: When the influence of one of the most common oral diseases such as RAS on OHR-QoL was taken into consideration, OHR-QoL provides an additional dimension that may help to improve the impact of a disease on an individual's life. In relation to this, colchicine seems to be one of the most effective management strategies used in RAS.

Plasma TM2-PK levels in mycosis fungoides patients.

Aerobic glycolysis increases in tumor cells and pyruvate kinase (PK) is one of the key enzymes involved; PK exists in different isoforms in various tissues. Tumor M2-PK (TM2-PK) is one of these isoforms and its expression has been observed in various tumor cells, including lymphocytes, and in lymphoproliferative disorders. The present study aimed to compare plasma levels of TM2-PK and serum levels of two established markers of various lymphoproliferative disorders-lactate dehydrogenase (LDH) and ß-2 microglobulin, and to evaluate the role of TM2-PK in drug monitorization and disease activity in mycosis fungoides (MF) patients. The study included 27 MF patients and 46 healthy controls. Among the MF patients, 18 were stage IA, 6 were stage IB, 1 was stage IIA, and 2 were stage III. Plasma TM2-PK, and serum LDH and ß-2 microglobulin levels in the patients and controls were measured using the ELISA technique, a kinetic method, and a chemiluminescent assay, respectively. Measurements were repeated in the patient group posttreatment. Median levels of TM2-PK, LDH, and ß-2 microglobulin level in the MF patients were 22 U mL⁻¹, 375 U L⁻¹, and 1,831 ng mL⁻¹, respectively. TM2-PK and ß-2 microglobulin levels did not significantly differ between the MF patients and controls; however, LDH levels were significantly higher in the MF patients. TM2-PK levels in 17 of the MF patients that were in remission did not significantly differ from their pre-therapy levels. Based on a cut-off point of 17.5 U mL⁻¹, the sensitivity and specificity of TM2-PK for diagnosing MF were 55.6 and 60.9%, respectively. ß-2 microglobulin was the most sensitive marker for diagnosing MF (63%), while LDH was the most specific marker. Furthermore, the sensitivity of TM2-PK increased when it was analyzed in combination as parallel tests with LDH and ß-2 microglobulin (86%), while the specificity was measured as 32%. In serial analysis, the specificity was increased to 98%, while the sensitivity was 5%. Statistically significant agreement in diagnosing MF was also noted between TM2-PK and LDH levels. TM2-PK may not be a useful marker for MF, especially in early-stage patients, because it proliferates slowly. We think that TM2-PK levels should be investigated in advanced-stage MF or in other types of cutaneous T-cell lymphomas; in particular, in combination with other established markers.

Narrowband ultraviolet-B phototherapy in pityriasis lichenoides chronica.

BACKGROUND: Current knowledge about the efficacy of narrowband UVB therapy for the treatment of pityriasis lichenoides is limited. OBJECTIVE: The aim of this study was to investigate the efficacy of narrowband UVB therapy for the treatment of pityriasis lichenoides chronica (PLC). METHODS: Data were retrospectively collected following a review of patient phototherapy and medical charts, and telephone interviews were performed for follow-up information. RESULTS: The study included 25 patients (14 male, 11 female) with a mean age of 34 +/- 13 years. Diagnosis was confirmed by histopathological examination in 92% (n = 23) of the patients. The median duration of the disease was 24 months (range: 2-192 months). The median number of sessions until response was 25 (8 weeks) (range: 9-77 sessions), with a median cumulative dose of 15 J/cm(2) (range: 2-158 J/cm(2)). Complete response and partial response were achieved in 48% and 44% of the patients, respectively, while 8% of the patients achieved no response. In those patients for whom follow-up data were available (n = 17), 10 (58%) relapsed within a median of 9.5 months (range: 1-44 months). CONCLUSIONS: Our results suggest that narrowband UVB is an effective and well-tolerated treatment option for PLC.

Spitz nevus of the genital mucosa.

We herein report an 11-year-old girl who came to our clinic with a swelling on the genital area of 2 months duration. Dermatological examination of the patient was performed and a pigmented lesion was found on the inner surface of the labium majus of the mucosa. The lesion was well circumscribed and approximately 1 cm in diameter, with homogenous color distribution. The patient was diagnosed as Spitz nevus on the basis of clinical and histopathological findings. Our case is probably the first reported case of Spitz nevus localized to the genital mucosa in the English literature.