PMID- 37846976 OWN - NLM STAT- MEDLINE DCOM- 20240219 LR - 20240219 IS - 1365-2133 (Electronic) IS - 0007-0963 (Linking) VI - 190 IP - 3 DP - 2024 Feb 16 TI - Safety of biologic therapy in combination with methotrexate in moderate to severe psoriasis: a cohort study from the BIOBADADERM registry. PG - 355-363 LID - 10.1093/bjd/ljad382 [doi] AB - BACKGROUND: Safety is an important consideration in decisions on treatment for patients with moderate-to-severe psoriasis and the study of drug safety is the main purpose of the BIOBADADERM registry. The combination of a biologic agent and a conventional systemic drug [generally methotrexate (MTX)] is a common treatment in clinical practice. However, there is a paucity of evidence from real-world practice on the safety of such combination regimens in the treatment of psoriasis. OBJECTIVES: The primary objective of this study was to ascertain whether the use of regimens combining biologic drugs with MTX in the management of moderate-to-severe psoriasis increases the risk of adverse events (AEs) or serious AEs (SAEs). We compared monotherapy using tumour necrosis factor (TNF), interleukin (IL)-17 and IL-23 inhibitors with the use of the same drugs in combination with MTX. METHODS: Using data from the BIOBADADERM registry, we compared biologic monotherapies with therapies that were combined with MTX. We estimated adjusted incidence rate ratios (aIRR) using a random effects Poisson regression with 95% confidence intervals for all AEs, SAEs, infections and serious infections and other AEs by system organ class. RESULTS: We analysed data from 2829 patients and 5441 treatment cycles, a total of 12 853 patient-years. The combination of a biologic with MTX was not associated with statistically significant increases in overall risk of AEs or SAEs in any treatment group. No increase in the total number of infections or serious infections in patients receiving combined therapy was observed for any group. However, treatment with a TNF inhibitor combined with MTX was associated with an increase in the incidence of gastrointestinal AEs (aIRR 2.50, 95% CI 1.57-3.98; P < 0.002). CONCLUSIONS: The risk of AEs and SAEs was not significantly increased in patients with moderate-to-severe psoriasis receiving different classes of biologic drugs combined with MTX compared with those on biologic monotherapy. CI - (c) The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. FAU - Lluch-Galcera, Juan Jose AU - Lluch-Galcera JJ AUID- ORCID: 0000-0002-8373-4303 AD - Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Universitat Autonoma de Barcelona, IGTP. Badalona, Barcelona, Spain. AD - Departament de Medicina, Universitat Autonoma de Barcelona (UAB), Barcelona, Spain. FAU - Carrascosa, Jose Manuel AU - Carrascosa JM AUID- ORCID: 0000-0003-4266-0771 AD - Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Universitat Autonoma de Barcelona, IGTP. Badalona, Barcelona, Spain. AD - Departament de Medicina, Universitat Autonoma de Barcelona (UAB), Barcelona, Spain. FAU - Gonzalez-Quesada, Alicia AU - Gonzalez-Quesada A AD - Department of Dermatology, Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, Islas Canarias, Spain. FAU - Rivera-Diaz, Raquel AU - Rivera-Diaz R AUID- ORCID: 0000-0002-4604-0724 AD - Department of Dermatology, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid, Spain. FAU - Sahuquillo-Torralba, Antonio AU - Sahuquillo-Torralba A AD - Department of Dermatology, Hospital Universitario y Politecnico La Fe, Valencia,Spain. FAU - Llamas-Velasco, Mar AU - Llamas-Velasco M AD - Department of Dermatology, Hospital Universitario de La Princesa, Instituto de Investigacion Sanitaria de La Princesa (IIS-LP), Madrid,Spain. FAU - Gomez-Garcia, Francisco Jose AU - Gomez-Garcia FJ AD - Department of Dermatology, Hospital Universitario Reina Sofia, Cordoba, Spain. FAU - Herrera-Acosta, Enrique AU - Herrera-Acosta E AD - Department of Dermatology, Hospital Universitario Virgen de la Victoria, Malaga, Spain. FAU - de la Cueva, Pablo AU - de la Cueva P AD - Department of Dermatology, Hospital Universitario Infanta Leonor, Madrid, Spain. FAU - Baniandres-Rodriguez, Ofelia AU - Baniandres-Rodriguez O AD - Department of Dermatology, CEIMI, Hospital General Universitario Gregorio Maranon, Madrid, Spain. FAU - Lopez-Estebaranz, Jose Luis AU - Lopez-Estebaranz JL AD - Department of Dermatology, Hospital Universitario Fundacion Alcorcon, Alcorcon, Madrid, Spain. FAU - Belinchon, Isabel AU - Belinchon I AD - Department of Dermatology, Hospital General Universitario de Alicante-ISABIAL-UMH, Alicante, Spain. FAU - Ferran, Marta AU - Ferran M AD - Department of Dermatology, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain. FAU - Mateu, Almudena AU - Mateu A AD - Department of Dermatology, Hospital Universitario Doctor Peset, Valencia, Spain. FAU - Rodriguez, Lourdes AU - Rodriguez L AD - Department of Dermatology, Hospital Virgen del Rocio, Seville, Spain. FAU - Riera-Monroig, Josep AU - Riera-Monroig J AUID- ORCID: 0000-0001-9265-1019 AD - Department of Dermatology, Hospital Clinic de Barcelona, UB, Barcelona, Spain. FAU - Abalde-Pintos, M Teresa AU - Abalde-Pintos MT AD - Department of Dermatology, Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Spain. FAU - Carretero, Gregorio AU - Carretero G AD - Department of Dermatology, Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, Islas Canarias, Spain. FAU - Garcia-Donoso, Carmen AU - Garcia-Donoso C AD - Department of Dermatology, Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid, Spain. FAU - Pujol-Marco, Conrad AU - Pujol-Marco C AD - Department of Dermatology, Hospital Universitario y Politecnico La Fe, Valencia,Spain. FAU - Del Alcazar, Elena AU - Del Alcazar E AD - Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Universitat Autonoma de Barcelona, IGTP. Badalona, Barcelona, Spain. AD - Departament de Medicina, Universitat Autonoma de Barcelona (UAB), Barcelona, Spain. FAU - Santamaria-Dominguez, Cristina AU - Santamaria-Dominguez C AD - Department of Dermatology, Hospital Universitario de La Princesa, Instituto de Investigacion Sanitaria de La Princesa (IIS-LP), Madrid,Spain. FAU - Suarez-Perez, Jorge Alonso AU - Suarez-Perez JA AD - Department of Dermatology, Hospital Universitario Virgen de la Victoria, Malaga, Spain. FAU - Nieto-Benito, Lula Maria AU - Nieto-Benito LM AD - Department of Dermatology, CEIMI, Hospital General Universitario Gregorio Maranon, Madrid, Spain. FAU - Ruiz-Genao, Diana Patricia AU - Ruiz-Genao DP AD - Department of Dermatology, Hospital Universitario Fundacion Alcorcon, Alcorcon, Madrid, Spain. FAU - Salgado-Boquete, Laura AU - Salgado-Boquete L AD - Department of Dermatology, Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Spain. FAU - Descalzo, Miguel Angel AU - Descalzo MA AD - Research Unit, Spanish Academy of Dermatology and Venereology, Madrid, Spain. FAU - Garcia-Doval, Ignacio AU - Garcia-Doval I AD - Research Unit, Spanish Academy of Dermatology and Venereology, Madrid, Spain. AD - Department of Dermatology, Complexo Hospitalario Universitario de Vigo, Vigo, Pontevedra, Spain. LA - eng GR - Fundacion Piel Sana of the Academia Espanola de Dermatologia y Venereologia/ GR - Spanish Medicines and Health Products Agency/ GR - Agencia Espanola de Medicamentos y Productos Sanitarios/ GR - Abbott/AbbVie/ GR - Almirall/ GR - Amgen/ GR - Biogen/ GR - Boehringer Ingelheim/ GR - Bristol Myers Squibb/ GR - Janssen/ GR - UCB/ GR - LeoPharma/ GR - Novartis Pharma/ GR - Lilly/ GR - MSD/ GR - Pfizer/ PT - Journal Article PL - England TA - Br J Dermatol JT - The British journal of dermatology JID - 0004041 RN - YL5FZ2Y5U1 (Methotrexate) RN - 0 (Biological Products) SB - IM CIN - Br J Dermatol. 2024 Jan 03;:. PMID: 38170214 CIN - Br J Dermatol. 2024 Feb 16;190(3):e30. PMID: 38366834 MH - Humans MH - Methotrexate MH - Cohort Studies MH - *Psoriasis/pathology MH - Registries MH - Biological Therapy MH - *Biological Products/adverse effects COIS- Conflicts of interest J.M.C. has participated as a speaker and/or advisor and/or principal investigator/senior investigator in clinical trials sponsored by for Celgene, Janssen, Lilly, Leo Pharma, Novartis, Pfizer, MSD, Biogen, Mylan, Amgen, AbbVie and Sandoz. A.G.-Q. acted as consultant and/or speaker for and/or participated in clinical trials as principal investigator and subinvestiator for AbbVie, Almirall, Amgen, Boehringer, Janssen, Leo Pharma, Lilly, Novartis, MSD, Pfizer-Wyeth and UCB. R.R.-D. acted as consultant and/or speaker for and/or participated in clinical trials as principal investigator for AbbVie, Almirall, Amgen, Boehringer, Janssen, Leo Pharma, Lilly, Novartis, MSD, Pfizer-Wyeth and UCB. A.S.-T. has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Celgene, Janssen-Cilag, LEO Pharma, Lilly, Novartis and Pfizer. M.L.-V. acted as a consultant and speaker and participated in clinical trials for Janssen-Cilag, AbbVie, Boehringer, Celgene, Pfizer, Novartis, Lilly, Almirall, UCB, Kyowa Kirin and Leo Pharma. E.H.-A. has served as consultant and/or speaker with Leo Pharma, Novartis, Janssen, Lilly, Celgene and AbbVie. P.d.l.C. acted as a consultant and/or speaker for Janssen-Cilag, AbbVie, MSD, Pfizer, Novartis, Lilly, Almirall, UCB, Biogen, Celgene, Amgen, Sandoz, Sanofi and Leo Pharma. O.B.-R. acted as a consultant and/or speaker for Janssen-Cilag, AbbVie, Pfizer, Novartis, Lilly, Celgene, Leo Pharma, Amgen, Boehringer, UCB and Almirall. L.L.-E. participated as advisory board member and received educational grants from Janssen, AbbVie, MSD, Lilly, Novartis, LeoPharma and Pfizer. I.B. acted as a consultant and/or speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including Janssen Pharmaceuticals Inc., Almirall SA, Lilly, AbbVie, Novartis, Celgene, Biogen Amgen, Leo Pharma, UCB, Pfizer-Wyeth and MSD. M.F. has participated as speaker and/or advisor for Janssen, Lilly, Novartis, Pfizer, MSD, AbbVie Celgene and Almirall. A.M. acted as consultant and/or speaker for AbbVie, Almirall, Celgene, Janssen, Leo Pharma, Lilly, Novartis. L.R. acted as a consultant and speaker for Janssen-Cilag, AbbVie, MSD, Pfizer, Novartis, Lilly, Almirall, Celgene and Leo Pharma. J.R.-M. acted as a consultant and/or speaker for and/or participated in clinical trials sponsored by AbbVie, Almirall, Janssen, Leo Pharma, Novartis, UCB, Pfizer, Lilly, Amgen and Boehringer Ingelheim. G.C. has been reimbursed by Janssen, AbbVie, Novartis, Pfizer, MSD and Celgene for advisory service and conference attendance. C.G.-D. participated as advisory board member for AbbVie, Almirall and speaker for Janssen, Lilly and Celgene. C.P.-M. acted as a consultant and/or speaker for Janssen-Cilag, AbbVie, MSD, Pfizer, Novartis, Lilly, Almirall, UCB, Celgene and Leo Pharma. E.D.A. has participated as a speaker and/or and/or PI/SI clinical trials sponsored by Amgen, Almirall, Janssen, Lilly, Leo Pharma, Novartis, UCB and AbbVie. J.A.S.-P. has served as consultant and/or speaker with Leo Pharma, Novartis, Janssen, Lilly, Celgene, AbbVie, Amgen, Sanofi, Almirall and Pfizer. D.P.R.-G. has been reimbursed by Pfizer, Janssen, Celgene, AbbVie, Novartis and LeoPharma for advisory services and conference attendance. I.G.D. received travel grants for congresses from AbbVie, MSD, Pfizer and Sanofi. EDAT- 2023/10/17 12:43 MHDA- 2024/02/19 06:42 CRDT- 2023/10/17 08:54 PHST- 2023/05/24 00:00 [received] PHST- 2023/09/27 00:00 [revised] PHST- 2023/09/28 00:00 [accepted] PHST- 2024/02/19 06:42 [medline] PHST- 2023/10/17 12:43 [pubmed] PHST- 2023/10/17 08:54 [entrez] AID - 7319598 [pii] AID - 10.1093/bjd/ljad382 [doi] PST - ppublish SO - Br J Dermatol. 2024 Feb 16;190(3):355-363. doi: 10.1093/bjd/ljad382.