Real-world apremilast use in biologic-naïve psoriatic arthritis patients. Data from Spanish clinical practice / Uso real de apremilast en pacientes con artritis psoriásica sin tratamiento biológico. Datos de la práctica clínica española

Introduction: Apremilast is approved for treatment of psoriasis and psoriatic arthritis (PsA). Real-world evidence on apremilast effectiveness in clinical practice is limited. Methods: Observational study enrolling adult patients, across 21 Spanish centres, who had initiated apremilast in the prior 6 (±1) months and were biologic naive. Data were collected at routine follow-up visits 6 and 12 months after apremilast initiation. Primary outcome was 6 and 12-month persistence to apremilast. Secondary outcomes included Disease Activity for PsA (DAPSA), joint erosions, enthesitis, dactylitis, and patient-reported quality of life (QoL, measured using the PsA impact of disease [PsAID] questionnaire). Results: We included 59 patients. Most had oligoarticular PsA, moderate disease activity, and high comorbidity burden. Three-quarters were continuing apremilast at 6 months and two-thirds at 12 months; mean (SD) apremilast treatment duration was 9.43 (1.75) months. DAPSA scores showed improved disease activity: one-third of patients in remission or low activity at apremilast initiation versus 62% and 78% at 6 and 12 months, respectively. Eleven of 46 patients with radiographic assessments had joint erosions at apremilast initiation and none at month 12. Median (Q1, Q3) number of swollen joints was 4.0 (2.0, 6.0) at apremilast initiation versus 0.0 (0.0, 2.0) at 12 months. Incidence of dactylitis and enthesitis decreased between apremilast initiation (35.6% and 28.8%, respectively) and month 12 (11.6% and 2.4%, respectively). Over two-thirds of patients had a PSAID-9 score <4 (cut-off for patient-acceptable symptom state) at month 12. Conclusions: In Spanish clinical practice, two-thirds of PsA patients continued apremilast at 12 months, with clinical benefits at the joint level, no radiographic progression of erosions, and a positive impact on patient-reported QoL.(AU)

Introducción: Apremilast está aprobado para el tratamiento de la psoriasis y la artritis psoriásica (APs). La evidencia sobre la efectividad de apremilast en la práctica clínica es limitada. Métodos: Estudio observacional en el que se incluyó a pacientes adultos, de 21 centros españoles, que habían iniciado apremilast en los 6 (± 1) meses previos y no habían recibido biológicos. Los datos se recogieron en visitas rutinarias de seguimiento a los 6 y 12 meses del inicio de apremilast. El objetivo primario fue la persistencia de apremilast a los 6 y 12 meses. Los objetivos secundarios incluyeron la actividad de la enfermedad para APs (DAPSA), erosiones articulares, entesitis, dactilitis y la calidad de vida informada por el paciente (CdV, medida mediante el cuestionario “PsA Impact of disease [PsAID]”). Resultados: Se incluyó a 59 pacientes. La mayoría presentaba APs oligoarticular, actividad moderada de la enfermedad y alta comorbilidad. Tres cuartas partes continuaban con apremilast a los 6 meses y 2 tercios a los 12 meses; la duración media (DE) del tratamiento con apremilast fue de 9,43 (1,75) meses. Las puntuaciones DAPSA mostraron una mejora de la actividad de la enfermedad: un tercio de los pacientes en remisión o baja actividad al inicio de apremilast frente al 62 y el 78% a los 6 y 12 meses, respectivamente. Once de 46 pacientes con evaluaciones radiográficas presentaban erosiones articulares al inicio de apremilast y ninguno en el mes 12. La mediana (Q1, Q3) del número de articulaciones inflamadas fue de 4,0 (2,0, 6,0) al inicio de apremilast frente a 0,0 (0,0, 2,0) a los 12 meses. La incidencia de dactilitis y la entesitis disminuyeron entre el inicio de apremilast (el 35,6 y el 28,8%, respectivamente) y el mes 12 (el 11,6 y el 2,4%, respectivamente). Más de 2 tercios de los pacientes tenían una puntuación PSAID-9 < 4 (punto de corte del estado sintomático aceptable para el paciente) en el mes 12.(AU)

Real-world apremilast use in biologic-naïve psoriatic arthritis patients. Data from Spanish clinical practice.

INTRODUCTION: Apremilast is approved for treatment of psoriasis and psoriatic arthritis (PsA). Real-world evidence on apremilast effectiveness in clinical practice is limited. METHODS: Observational study enrolling adult patients, across 21 Spanish centres, who had initiated apremilast in the prior 6 (±1) months and were biologic naive. Data were collected at routine follow-up visits 6 and 12 months after apremilast initiation. Primary outcome was 6 and 12-month persistence to apremilast. Secondary outcomes included Disease Activity for PsA (DAPSA), joint erosions, enthesitis, dactylitis, and patient-reported quality of life (QoL, measured using the PsA impact of disease [PsAID] questionnaire). RESULTS: We included 59 patients. Most had oligoarticular PsA, moderate disease activity, and high comorbidity burden. Three-quarters were continuing apremilast at 6 months and two-thirds at 12 months; mean (SD) apremilast treatment duration was 9.43 (1.75) months. DAPSA scores showed improved disease activity: one-third of patients in remission or low activity at apremilast initiation versus 62% and 78% at 6 and 12 months, respectively. Eleven of 46 patients with radiographic assessments had joint erosions at apremilast initiation and none at month 12. Median (Q1, Q3) number of swollen joints was 4.0 (2.0, 6.0) at apremilast initiation versus 0.0 (0.0, 2.0) at 12 months. Incidence of dactylitis and enthesitis decreased between apremilast initiation (35.6% and 28.8%, respectively) and month 12 (11.6% and 2.4%, respectively). Over two-thirds of patients had a PSAID-9 score <4 (cut-off for patient-acceptable symptom state) at month 12. CONCLUSIONS: In Spanish clinical practice, two-thirds of PsA patients continued apremilast at 12 months, with clinical benefits at the joint level, no radiographic progression of erosions, and a positive impact on patient-reported QoL. Trial registration number Clinicaltrials.gov: NCT03828045.

Abatacept in patients with rheumatoid arthritis and interstitial lung disease: A national multicenter study of 63 patients.

OBJECTIVE: Interstitial lung disease (ILD) is one of the most serious complications of rheumatoid arthritis (RA). In the present study, we aimed to assess the efficacy of abatacept (ABA) in patients with ILD associated to RA. METHODS: National multicenter, non-controlled, open-label registry study of RA patients with ILD treated with ABA. RESULTS: 63 patients (36 women) with RA-associated ILD undergoing ABA therapy were studied. The mean ± standard deviation age at the time of the study was 63.2 ± 9.8 years. The median duration of RA and ILD from diagnosis were 6.8 and 1 year, respectively. RA was seropositive in 55 patients (87.3%). In 15 (23.8%) of 63 patients the development of ILD was closely related to the administration of synthetic or biologic disease modifying anti-rheumatic drugs. After a follow-up of 9.4 ± 3.2 months, two-thirds of patients remained stable whereas one-quarter experienced improvement in the Modified Medical Research Council scale. At that time forced vital capacity remained stable in almost two-thirds of patents and improved in one out of five patients assessed. Also, diffusing capacity of the lung for carbon monoxide remained stable in almost two-thirds and showed improvement in a quarter of the patients assessed. At 12 months, 50% of the 22 patients in whom chest HRCT scan was performed due persistence of respiratory symptoms showed stabilization, 8 (36.4%) improvement and 3 worsening of the HRCT scan pattern. Eleven of 63 patients had to discontinue ABA, mainly due to adverse events. CONCLUSION: ABA appears to be an effective in RA-associated ILD.