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Background: BI 695501 is an approved biosimilar to Humira ® reference product (RP).Research design and methods: In this randomized Phase III trial (VOLTAIRE-PSO), patients with moderate-to-severe chronic plaque psoriasis received BI 695501 or adalimumab RP (24-week treatment). Primary efficacy endpoint: the proportion of patients with ≥75% reduction in Psoriasis Area and Severity Index (PASI 75) response at week 16 (±18% equivalence limits for two-sided 95% confidence interval between treatment groups). Safety, pharmacokinetics, and immunogenicity were also assessed. Results: Baseline characteristics were balanced between treated groups (BI 695501, n = 159; adalimumab RP, n = 158). PASI 75 response rates (full analysis set, n = 158; n = 157) were 68.2% (BI 695501) and 70.4% (adalimumab RP) at week 16 (95% CI: −14.4%, 8.7%), and 75.3% and 72.4%, at week 24, respectively. At week 24, 41.5% (BI 695501) and 44.9% (adalimumab RP) of treated patients had treatment-emergent adverse events (AEs), 3.1% and 4.4% had serious AEs, and 0.0% and 1.9% had AEs of special interest. Of treated patients, 75.3% (BI 695501) and 77.9% (adalimumab RP) were anti-drug antibody-positive. Conclusion: These data demonstrate equivalent efficacy and highly similar safety and immunogenicity between BI 695501 and adalimumab RP in patients with chronic plaque psoriasis.

Background Long-term efficacy and safety of ixekizumab [160 mg at week 0, then 80 mg every 2 weeks (Q2W) for 12 weeks, followed by every 4 weeks (Q4W) thereafter (i.e. Q2W/Q4W), which is the labelled psoriasis dosing where approved, except in Japan] have been established for the treatment of adults with moderate-to-severe plaque psoriasis. However, some patients may benefit from remaining on Q2W dosing beyond 12 weeks. Methods Among patients who had static Physician's Global Assessment (sPGA) > 1 at week 12, efficacy through week 52 of continuous Q2W dosing in the IXORA-P study was compared indirectly with Q2W/Q4W in the integrated data from the UNCOVER-1, UNCOVER-2 and UNCOVER-3 studies. The continuous Q4W dose group, which had comparable results across studies, was used as the common comparator. Results In the IXORA-P study, among patients with sPGA > 1 at week 12, 64% of patients in the continuous Q2W group achieved sPGA ≤ 1 at week 52, which was statistically significantly higher than the 36% of patients with sPGA > 1 in the Q2W/Q4W group based on the integrated data from the UNCOVER studies (P = 0Á0007). There were no clinically meaningful differences in frequencies of safety events between patients with sPGA ≤ 1 and patients with sPGA > 1 at week 12 in the IXORA-P study. Conclusions Among patients who did not have clear or almost clear skin at week 12, nearly 30% more patients who were treated continuously with ixekizumab Q2W in IXORA-P had clear or almost clear skin at week 52 when compared indirectly with those who were treated using the labelled psoriasis dosing in integrated UNCOVER studies. What's already known about this topic? • Most patients with moderate-to-severe psoriasis who were given the labelled psoriasis dosing of ixekizumab [160-mg loading dose at week 0, 80 mg every 2 weeks (Q2W) through week 12, and 80 mg every 4 weeks (QW4) thereafter] respond quickly with a high percentage of skin clearance.

4990 Background: Mycosis fungoides is the most common type of cutaneous T-cell lymphoma. Early stage disease is effectively managed with skin directed therapies such as UV light and topical steroids. Excimer laser (EL) delivers monochromatic, UVB light at a wavelength of 308 nm via hand held device that covers an area of 2 × 2 cm. It generates a short-pulse radiation that is concentrated on an affected area of skin, thereby allowing a delivery of higher dose on precisely targeted tissue. In contrast to other phototherapy techniques such as narrow band UV light, the EL is ideally suited for patients with small number of patch lesions. Although EL was successfully utilized in the management of psoriasis and vitiligo, there is not extensive experience with this modality in patients with CTCL. Objectives: To assess safety and efficacy of EL therapy in patients with early stage MF who failed ≥1 skin directed therapy. Design and Methods: This is a retrospective analysis of seven consecutive patients with stage 1 MF treated with EL phototherapy between January 2011 and August 2011 in a single institution. Seven patients with histologically confirmed common type MF, and one patient with folliculotropic MF received 308 nm EL therapy after failure of at least one prior skin directed therapy. The median age was 48 years (range 24–77 yrs). Four (57%) were male, 3 (43%) were female, six (86%) were Caucasian, and 1(14%) were African American. Biopsies and photos were obtained at diagnosis and after the completion of 24 treatments. Results: Treatment was initiated at a dose of 200 millijoules (mJ) and was increased by 10–15% each subsequent treatment. The max dose of treatment ranged from 240 mJ to 850 mJ. The total number of administered treatments was 24 delivered over period of 3 months. The median number of treated lesions was 2 (range 1–5). The surface area of treated lesions was <10%. Six patients achieved clinical improvement in appearance of lesions and intensity of pruritis; 2 (29%) achieved clinical remission as confirmed with photos and post-treatment biopsies. One (14%) patient developed first degree burn and 1 (14%) patient developed pruritis. These resolved by the second treatment with EL. There were no treatment-related serious adverse events observed. Conclusion: Our results suggest that EL is effective and well tolerated skin-directed treatment modality for selected patients with early stage MF. However, longer follow-up will be required to assess durability of responses. Advantages of this approach include shorter treatment duration and lower risk of carcinogenesis in the non-affected areas of skin. Prospective study with a larger cohort of patients is necessary to further assess efficacy and safety of this approach. Disclosures: No relevant conflicts of interest to declare.