Real-life data demonstrate the potential of methotrexate in severe and moderately severe psoriasis

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1 Page 1 / 5 Medac at the EADV Congress Real-life data demonstrate the potential of methotrexate in severe and moderately severe psoriasis First French guidelines for psoriasis therapy - subcutaneous MTX is First-Line Paris / Wedel (14 September 2018). Methotrexate (MTX) is established and proven as an effective systemic first-line therapeutic agent in the treatment of psoriasis. 1 MTX is and remains the world's most widely used systemic therapy, even despite new active substances entering the market. With the presentation of yet unpublished study data at the Medac-sponsored symposium, this year's EADV Congress in Paris once again confirms the importance of methotrexate as the first-line treatment of moderately severe to severe psoriasis. 2 French National Guideline - Subcutaneous Methotrexate First-Line It has often been proven in rheumatological studies that the subcutaneous (sc) administration of methotrexate improves response and reduces therapy failure. 3,4 Better bioavailability and higher effectiveness with subcutaneous MTX administration especially with doses 15 mg / week can therefore now be considered as established. 4,5,6 The advantages of a starting dose of 15 mg / week are 1 Gyulai R et al. Current practice of methotrexate use for psoriasis: results of a worldwide survey among dermatologists. J Eur Acad Dermatol Venereol. 2015;29: Medac satellite-symposium Are we using the full potential of subcutaneous methotrexate in systemic psoriasis therapy for moderate and severe patients?, on the occasion of the European Academy of Dermatology and Venerology (EADV) 13. September 2018 in Paris. 3 Hazlewood GS et al. The comparative effectiveness of oral versus subcutaneous methotrexate for the treatment of early rheumatoid arthritis. Ann Rheum Dis 2016;75: O'Connor A et al. The rapid kinetics of optimal treatment with subcutaneous methotrexate in early inflammatory arthritis: an observational study. BMC Musculoskelet Disord. 2016;17: Schiff MH et al. Head-to-head, randomised, crossover study of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis: drug-exposure limitations of oral methotrexate at doses 15 mg may be overcome with subcutaneous administration. Ann Rheum Dis. 2014;73:

2 Page 2 / 5 also increasingly recognised as a part of current guidelines. 7,8 In addition to the good safety profile and the sustained efficacy, which were yet again proven in the METOP study 9, these are the reasons for the first-line positioning of parenteral methotrexate in the new French guidelines, stressed Professor MARIE-ALETH RICHARD in her presentation. The first French guidelines ever for the treatment of psoriasis, advise against a "low test dose" and recommend a dose of mg for the start of therapy. This continued first-line classification of MTX in systemic therapy in international and national guidelines underscores its relevance for the treatment of severe and moderately severe psoriasis. METOP study data prove advantage of sc MTX, also in moderately severe psoriasis The METOP study published in the Lancet last year confirms the benefits of an optimised higher dosage and subcutaneous administration of methotrexate over 52 weeks. 9 This also demonstrated a particularly good PASI response for MTX-naive patients, emphasised Professor ULRICH MROWIETZ during his presentation. A POSTER CONTRIBUTION 10 to a practice documentation at the EADV showed just how decisive the form of application is for compliance in addition to the therapy response. According to this study, 97% of all physicians and 92% of psoriasis patients with a previous experience of pre-filled syringes prefer the metex PEN and perceive it as "very advantageous" or "beneficial". Another aspect discussed at the symposium was the efficacy of subcutaneous MTX in severe versus moderately severe forms of psoriasis. The reason was the recent extension of the marketing 6 Pichlmeier U, Heuer KU. Subcutaneous administration of methotrexate with a prefilled autoinjector pen results in a higher relative bioavailability compared with oral administration of methotrexate. Clin Exp Rheumatol. 2014;32: Nast A et al. European S3-Guidelines on the systemic treatment of psoriasis vulgaris Update 2015 Short version EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015;29: Nast A et al. S3-Leitlinie zur Therapie der Psoriasis vulgaris Update - Kurzfassung Teil 1 - Systemische Therapie (German guideline on the psoriasis treatment). JDDG. 2018;16: Warren RB et al. An intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis (METOP): a 52 week, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;389: Hattesohl M et al. Usability of a pre-filled pen for self-administration of subcutaneous methotrexate. EADV 2018/Paris, P1936 (Date: ).

3 Page 3 / 5 authorisation for the metex PEN 11 as the world's first authorisation for methotrexate with an indication in moderately severe psoriasis. 12 A METOP sub-analysis demonstrated that the severe and moderately severe forms benefit from a rapid onset of action and a comparably good as well as sustained efficacy under MTX: already after 16 weeks, the PASI had decreased from 25 to 6 for the severe forms and from 14 to 4.5 for the moderately severe forms. After 52 weeks, the PASI was only 3.2 and 2.4, respectively. German real-life data: better PASI reduction than in study This good data situation was endorsed by Professor KAMRAN GHORESCHI based on unpublished compared therapy data of subcutaneous administered methotrexate in moderately severe and severe psoriasis. On the one hand, the METOP study data served as the basis for the analysis (manuscript submitted) and on the other hand, a current evaluation of the German psoriasis register, called PsoBest. The reallife PsoBest registry data show even better PASI 75 values for both progression forms in the short and long-term, than in the METOP study slightly in favour of the moderately severe forms. After 14 / 16 weeks, the PASI 75 already lies at 56.9% versus 45.1% in the METOP study for moderately severe psoriasis according to PsoBest (Fig. 1). For severe psoriasis, the values are 65.2 versus After approximately one year (54 / 52 weeks for PsoBest and METOP), the register response rates of the moderately severe cases are 69.8 versus 54.9%. For the severe forms of progression, a rise from 54.4% to 61.9% can be observed in the evaluation of the register versus the study results Equivalent to Metoject PEN und metojectpen Medac press release dated

4 Page 4 / 5 Fig. 1: The compared data show a sustained good PASI 75 response in moderately severe and severe psoriasis after 14 and 54 (PsoBest) and 16 and 52 (METOP) weeks respectively, with a better result in the real-life data. medac In addition to the field reports from dermatological practice and after the METOP study, the real-life data again show the potential of the well-established substance methotrexate - especially with subcutaneous administration and optimised dosage. The repeated first-line positioning of methotrexate in national guidelines and the real-life data also substantiate the continued relevance of MTX in psoriasis therapy. medac 4,928 characters (spaces included)

5 Page 5 / 5 Press Contact Media Spokesperson Volker Bahr Tel. +49 (0) Fax +49 (0) press@medac.de medac Gesellschaft für klinische Spezialpräparate mbh Theaterstraße Wedel Germany medac Gesellschaft für klinische Spezialpräparate mbh medac is a privately held German pharmaceutical company located near Hamburg in Wedel and Tornesch. Medicinal products from medac support doctors and patients throughout the world in overcoming their acute and persistent diseases in the indication areas of oncology & haematology, urology and autoimmune disorders. In addition, medac develops and markets special diagnostic test systems. Since 1970, medac has been committed to unifying therapeutic and diagnostic agents under one roof. You can find further information on the company and its products on the internet under