PO:07:101 | Efficacy and safety of methotrexate in a cohort of patients affected by early-onset rheumatoid arthritis: a monocentric real-life study

Carlo Cauli¹, Martina Favretti², Giulio Dolcini², Vincenzo Ferraro¹, Cristina Iannuccelli³, Fabrizio Conti¹, Manuela Di Franco¹ | ¹UOC Reumatologia, Dipartimento di scienze cliniche internistiche anestesiologiche e cardiovascolari, Sapienza, Roma; ²Dipartimento di Medicina Molecolare, La Sapienza, Roma; ³UOC Reumatologia, AOU Policlinico Umberto I, La Sapienza, Roma, Italy

Background. Methotrexate (MTX) is the first-line Disease Modifying Anti-Rheumatic Drug (DMARD) in the treatment of rheumatoid arthritis (RA). According to EULAR guidelines, patients with RA should start immunosuppressive therapy at the time of diagnosis, achieve clinical improvement within 3 months, and remission within 6 months. The objective of this monocentric, retrospective, real-life study was to evaluate the achievement of the therapeutic target in a cohort of patients affected by early-onset RA treated with MTX. Further objectives were to evaluate the MTX ability to act as a “steroid sparing” agent, assess its safety, and the monotherapy maintenance rate.

Materials and Methods. Patients attending the Early Arthritis Clinic from 2006 to the present, affected by RA (ACR 2010 criteria) who had started MTX therapy within 24 weeks from symptom onset, were enrolled. Demographic, clinical, pharmacological, clinimetric indices, and any adverse events associated with therapy were recorded at baseline (T0) and during follow-up until MTX discontinuation or switch to biotechnological therapy.

Results. Table 1 reports demographic and clinical data of the 78 enrolled patients. Graph 2 shows disease activity according to DAS28-PCR and SDAI (2a; 2b) and the percentage of Boolean remission (2c) at follow-up. The median time to achieve remission or low disease activity was 3 months, both according to DAS28-PCR and SDAI (graph 3a). Referring to remission only, the median was 6 months according to DAS28-PCR, while it was 24 months according to SDAI and Boolean Remission 2.0 definition (graph 3b). It emerged that in patients treated with MTX, the mean prednisone dose progressively decreases by 0.08 mg per month, while the probability of continuing steroid therapy decreases by 10% for each month of treatment. Therapy persistence was 7 years in half of the patients (graph 4a), while the median MTX monotherapy maintenance was 6 years (graph 4b).

Conclusions. To our knowledge, this is the first monocentric study that evaluated in real life the efficacy and safety of MTX in early RA patients. MTX confirms its role as an anchor drug in the treatment of RA, with a probability of achieving the therapeutic target already at 3 months in two-thirds of patients with recent disease onset. Our data confirm the higher stringency of SDAI and Boolean Remission 2.0 compared to DAS28-PCR. MTX significantly reduces the steroid dose until discontinuation. Finally, in our cohort, it showed a good safety and clinical efficacy profile, with good therapy persistence.