ABSTRACT
Background Vitiligo, a chronic autoimmune depigmenting skin disease, affects a significant portion of the global population. One of the topical treatment options for vitiligo is basic fibroblast growth factor (bFGF)-related decapeptide (bFGFrP) 0.1% solution. This study aimed to assess the real-world effectiveness and safety of decapeptide in treating vitiligo. Methods This retrospective analysis utilized data collected from routine clinical practice in the management of vitiligo, focusing on patients treated with topical decapeptide lotion (Melgain™, manufactured by Zydus Healthcare Ltd., Ahmedabad, India). The primary outcome measures included the extent of re-pigmentation (EOR) and the grade of re-pigmentation (GOR) assessed at each follow-up visit. Results The analysis included data from 65 patients (24 males and 41 females) with an average age of 30.83 years. Segmental vitiligo was present in 52.31% of cases, with the face being the most commonly affected site. Among the patients, 33 received decapeptide as monotherapy, while 32 received decapeptide alongside adjuvant drug/phototherapy. The mean duration of treatment was five months. The first, second, and final follow-ups were observed to be at a mean of 45 days, two months, and five months, respectively. During the second and final follow-up, a significant response (>75% re-pigmentation) was observed in 12% (eight) and 71% (46) of the patients. A mild response (<50% re-pigmentation) was noted in 45% (29) of the patients during the first follow-up visit, 15% (10) during the second follow-up visit, and 6% (four) during the final follow-up visit. Grade 6 and 7 re-pigmentation occurred in a higher number of patients at the final visit, indicating treatment effectiveness. Overall, nearly all patients (96.92%) reported excellent tolerability of the decapeptide lotion based on the global assessment of tolerability. Conclusion This real-world study demonstrates that decapeptide promotes re-pigmentation and improves patient outcomes in vitiligo. Both decapeptide regimens, as monotherapy or in combination with other therapies, were effective and well tolerated by most patients. Thus, decapeptide represents a safe and effective therapeutic option for vitiligo treatment.
ABSTRACT
Background: Although second-generation antihistamines (SGAHs) are recommended as first-line drugs in chronic spontaneous urticaria (CSU), symptom relief has been reported in <50% of patients at licensed doses and up to fourfold dosing is recommended for these patients. Bilastine (SGAH), at licensed doses and higher doses, is efficacious in CSU. However, large-scale real-world data is scarce. Objectives: To report the real-world evidence of the safety and effectiveness of bilastine at a double dose (40-mg per day) in CSU management. Materials and Methods: In this retrospective questionnaire-based study carried out from February 2022 to July 2022, a pre-validated questionnaire was used to gather data on patients with CSU in dermatology practice from 62 centres across India. Adult patients of either gender diagnosed with CSU and switched over to bilastine 40 mg/day due to a non-satisfactory response (UCT score <12) to other antihistamines at double dose were considered for analysis. Based on UCT scores, patients were classified as responders (UCT ≥12) and non-responders at follow-up assessment at 2 weeks as compared to baseline. Results: 177 patients with a mean disease duration of 2.11 ± 1.48 years were included in the final analysis, with 53% females and 47% males. At the end of two weeks, 74/177 (42%) patients were classified as responders, and 103/177 (58%) were non-responders to Bilastine 40 mg/day. The mean change of UCT score from 5.0 ± 2.2 at baseline to 8.08 ± 5.41 (62% improvement) was significant (P < 0.001). Sedation was reported by ten patients without any discontinuation of treatment. Conclusion: Bilastine 40 mg/day was effective and well-tolerated in controlling CSU symptoms refractory to antihistamines at double doses.
ABSTRACT
Apremilast, an oral phosphodiesterase-4 inhibitor, is approved for use in the management of psoriasis and psoriatic arthritis. Although its efficacy and safety have been well established in clinical studies, in real-world settings, different practice scenarios have been reported. This review paper serves to evaluate clinical real-world scenarios and aspects of treatment for which the information in the literature was considered to be lacking or controversial. Following a literature review, a panel of five dermatologists with expertise in psoriasis considered five scenarios; namely, the positioning of apremilast in psoriasis, its use in difficult-to-treat areas, special conditions and populations, safety, dose titration and dose in maintenance therapy. These were then assessed with psoriasis experts in India using a web-based questionnaire. A total of 28 questions were discussed regarding these scenarios. According to the responses, apremilast is effective in stable mild to moderate psoriasis as monotherapy and in severe psoriasis in combination. Also, a positive response was received with regard to its effectiveness in difficult locations such as the scalp, palms and soles. To reduce adverse effects, prolonged titration therapy over 4 weeks is required and lower doses can be prescribed to maintain remission. Apremilast therapy should be continued for a minimum of 8 weeks once initiated to achieve the desired results, and the total duration of therapy should be about 24 weeks for better efficacy. It is also effective in many other cases, such as obese patients, patients with hepatitis B or C and HIV, or patients on polypharmacy. It was also reported that apremilast requires less prescreening and monitoring than other conventional and biologic systemic therapies. Overall, apremilast is an attractive option for the individualized treatment of psoriasis owing to its favorable safety profile, its ease of oral administration without the need for screening or ongoing laboratory monitoring, and its positive impact on symptoms and lesions in difficult-to-treat areas.
