Abstract
To investigate whether tumour necrosis factor inhibitor (TNFi) combination therapy with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) is more effective for psoriatic arthritis (PsA) and/or improves TNFi drug survival compared to TNFi monotherapy.
Methods
Five PsA biologics cohorts were investigated between 2000 and 2015; the ATTRA registry (Czech Republic), the Swiss Clinical Quality Management PsA registry, the Hellenic Registry of Biologics Therapies (Greece), the University of Bari PsA biologics database (Italy) and the Bath PsA cohort (UK). Drug persistence was analysed using Kaplan-Meier and equality of survival using Log-Rank tests. Comparative effectiveness was investigated using logistic regression with propensity scores. Separate analyses were performed on: (a) the combined Italian/Swiss cohorts for change in rate of DAS-28; and (b) the combined Italian, Swiss and Bath cohorts for change in rate of HAQ.
Results
In total, 2294 patients were eligible for the drug survival analysis. In the Swiss (p=0.002), Greek (p=0.021) and Bath (p=0.014) databases patients starting TNFi in combination with MTX had longer drug survival compared to monotherapy, whilst in Italy the monotherapy group persisted longer (p=0.030). In patients from the combined Italian/Swiss dataset (n=1066) there was no significant difference between treatment arms in rate of change of DAS28. Similarly, when also including the Bath cohort (n=1205) there was no significant difference in rate of change of HAQ.
Conclusion
Combination therapy of a TNFi with a csDMARD does not appear to affect improvement of disease activity or HAQ versus TNFi monotherapy but may improve TNFi drug survival.
| Original language | English |
|---|---|
| Pages (from-to) | 48-57 |
| Journal | The Journal of Rheumatology |
| Volume | 48 |
| Issue number | 1 |
| Early online date | 1 Apr 2020 |
| DOIs | |
| Publication status | Published - 1 Jan 2021 |
Funding
The study was funded by a nonrestricted investigator-initiated award from Pfizer. 1M.L. Thomas, PhD, Department of Mathematical Science, University of Bath, Bath, UK; 2G. Shaddick, PhD, Department of Mathematics, University of Exeter, Exeter, UK; 3R. Charlton, PhD, N. McHugh, MBChB, MD, FRCP, FRCPath, A. Nightingale, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; 4C. Cavill, BSc, R. Holland, MD, Royal National Hospital for Rheumatic Diseases, Bath, UK; 5F. Iannone, MD, PhD, G. Lapadula, MD, S. Lopriore, MD, Rheumatology Unit—DETO, University of Bari, Bari, Italy; 6J. Závada, MD, PhD, K. Pavelka, MD, PhD, Institute of Rheumatology, Prague, Czech Republic; 7M. Uher, MSc, L. Szczuková, MD, Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic; 8P. Sidiropoulos, MD, PhD, I. Flouri, MD, Rheumatology, Clinical Immunology and Allergy Department, Medical School, University of Crete, Crete, Greece; 9A. Drosos, MD, PhD, Rheumatology Clinic, Department of Internal Medicine, Medical School, University of Ioannina, Ioannina, Greece; 10B. Möller, Professor, Department of Rheumatology, Immunology & Allergology, Inselspital, University Hospital Bern, Bern, Switzerland; 11M.J. Nissen, MBBS, FRACP, Department of Rheumatology, University Hospital Geneva, Geneva, Switzerland; 12R.B. Müller, MD, Cantonal Hospital, Lucerne, Switzerland; 13A. Scherer, PhD, SCQM Foundation, Zürich, Switzerland. N. McHugh and A. Nightingale are joint senior authors. NM, AN, RC, MT and CC report grants from Pfizer during the conduct of the study. NM reports personal fees from AbbVie and Lilly and grants from Lilly outside the submitted work. CC reports grants from Celgene, Lilly and Novartis and personal fees from Novartis outside of the submitted work. FI reports personal fees from AbbVie, BMS, Novartis, Pfizer, Lilly, UCB and MSD outside the submitted work. GL reports personal fees from AbbVie, BMS, Novartis, Pfizer, and MSD outside the submitted work. KP reports honoraria for consultations and speaker fees from AbbVie, Pfizer, UCB, Lilly, Novartis, and Roche outside the submitted work. PS reports that the Hellenic Registry for Biologic Therapies was supported in part by the Hellenic Rheumatology Society through unrestricted grants from Schering-Plough, AbbVie, Pfizer, Bristol Myers Squibb, and Roche during the conduct of the study. These companies had no role in study design, collection, analysis, and interpretation of the data and in the writing of the manuscript. PS also reports grants and personal fees from the pharma industry through the University of Crete Special Account for Research, outside the submitted work. Address correspondence to Prof. N. McHugh, Department of Pharmacy & Pharmacology, University of Bath, Claverton Down, Bath BA2 7AY, UK. Email: [email protected]. Accepted for publication March 18, 2020.