RENACER study: Assessment of 12-month efficacy and safety of 168 certolizumab PEGol rheumatoid arthritis-treated patients from a Spanish multicenter national database.

OBJECTIVE: To assess effectiveness and safety of certolizumab PEGol (CZP) in rheumatoid arthritis (RA) patients after 12 months of treatment and to detect predictors of response. METHODS: Observational longitudinal prospective study of RA patients from 35 sites in Spain. Variables (baseline, 3- and 12-month assessment): sociodemographics, previous Disease Modifying Anti-Rheumatic Drug (DMARD) and previous Biological Therapies (BT) use; TJC, SJC, ESR, CRP, DAS28, SDAI. Response variables: TJC, SJC, CRP, ESR, and steroids dose reductions, EULAR Moderate/Good Response, SDAI response and remission, DAS28 remission. Safety variables: discontinuation due to side-effects. Descriptive, comparative and Logistic regression analyses were performed. RESULTS: We included 168 patients: 79.2% women, mean age 54.5 years (±13.2 SD), mean disease duration 7.5 years (±7.3 SD). Mean number of prior DMARD: 1.4 (±1.2 SD), mean number of prior BT was 0.8 (±1.1). Mean time on CZP was 9.8 months (±3.4 SD). A total of 71.4% were receiving CZP at 12-month assessment. Baseline predictors of response: lower prior number DMARD; low number prior BT; higher CRP, ESR, TJC, SJC, DAS28 and SDAI (p < 0.05) scores. A 25/46.4% Moderate/Good Response, a 20% SDAI remission, and a 44% DAS28 remission were observed. We observed 48 discontinuations (28.6%), 31 due to partial or complete ineffectiveness, and 17 due to side-effects. CONCLUSIONS: CZP showed benefit in severe RA patients, with significant reduction of all effectiveness parameters, despite the high prevalence of previous BT exposure in our series. We found CRP, ESR, prior DMARD/BT number, TJC, SJC, DAS28, and SDAI as baseline predictors of response. CZP was mostly well tolerated.

Prospective multicentre study of experience in real-world clinical practice in monitoring reported outcome measures (PROMs) of patient with a diagnosis of psoriatic and/or spondyloarthritis and initiating treatment with secukinumab. / Estudio prospectivo multicéntrico de experiencia en práctica clínica real en el control de medidas de desenlace reportadas por el paciente (PRO) diagnosticado de artritis psoriásica y/o espondiloartritis y que inicia tratamiento con secukinumab.

OBJECTIVE: To analyse the effect of secukinumab on self-reported variables of patients diagnosed with psoriatic arthritis and/or ankylosing spondylitis in relation to their health status, pain, fatigue, sleep and quality of life. METHODS: A six-month, observational, longitudinal, prospective, multicentre study was conducted with 39 patients who initiated treatment with secukinumab as therapy for psoriatic arthritis and/or spondylitis. The main variables were changes in patient-reported measures and they were evaluated by means of the questionnaires: FACIT-fatigue, Insomnia Severity Index, EuroQol-3L-5D and PsAQoL. In addition, depending on the type of disease (peripheral psoriasis or spondyloarthritis) the DAS28 with ESR or the BASDAI were calculated, respectively. RESULTS: Levels of fatigue, moderate and severe insomnia significantly reduced after 6months of treatment with secukinumab. At the same time, patient-reported quality of life increased significantly (P=.006). Data on pain and discomfort also show significant improvement after the treatment. CONCLUSIONS: Patients with psoriatic arthritis and/or ankylosing spondylitis who start treatment with secukinumab show improvement at 6months in all effect sizes of the treatment, particularly in sleep, fatigue and quality of life. Furthermore, patient-reported outcome measures are of additional clinical value and allow more accurate and closer assessment of their real status of health and well-being.

Urticaria due to etanercept in a patient with psoriatic arthritis.

A 50-year-old woman was referred to our emergency room because of urticaria. Eleven days after etanercept therapy was started, the patient developed an urticarial rash of the trunk and face. A diagnosis of generalized urticaria was made. Etanercept treatment was suspended. Treatment was started with methylprednisolone and dexchlorpheniramine. The patient's condition improved and she was discharged. In this case, the most probable cause of urticaria was considered to be etanercept because of the temporal relationship between exposure to the drug and the onset of symptoms. The adverse reaction could be considered probable. Although the overall risk of skin adverse events associated with etanercept appears low, clinicians should be aware of this reaction.

Parapharyngeal abscess in a patient receiving etanercept.

OBJECTIVE: To report a case of parapharyngeal abscess associated with Streptococcus viridans in a patient with rheumatoid arthritis receiving treatment with etanercept. CASE SUMMARY: A 40-year-old man diagnosed with rheumatoid arthritis had received treatment with nonsteroidal antiinflammatory drugs, methotrexate, and deflazacort. Six months prior to admission, the patient had a Disease Activity Score of 3.4; clinicians decided to start treatment with etanercept. Chest X-rays were normal and the tuberculin skin test was negative. Treatment with etanercept plus methotrexate was started. Three months later, methotrexate was discontinued. Six months after etanercept therapy was started, the patient presented to our emergency department with a swelling of his neck, odynophagia, otalgia, and trismus. The clinical course was consistent with parapharyngeal abscess. Etanercept treatment was suspended. The parapharyngeal abscess was drained and intravenous methylprednisolone, amoxicillin/clavulanic acid, and clindamycin were administered. The parapharyngeal abscess secretion culture was positive for S. viridans and Bacteroides spp. The patient's condition improved with antibiotic therapy; he was discharged 5 days after admission. DISCUSSION: Tumor necrosis factor-alpha plays an essential role in the immune-mediated response to infection. In our patient, the most possible cause of parapharyngeal abscess was considered to be etanercept because of the temporal relationship between exposure to the drug and onset of symptoms. Etanercept was the only drug administered before the abscess developed. Based on the Naranjo probability scale, an association between etanercept and the adverse reaction could be considered possible. CONCLUSIONS: Patients initiated on etanercept therapy should be closely monitored for the development of tuberculosis and other infections. During treatment, all febrile or novel illnesses should be evaluated promptly. If clinical evaluation leads to the suspicion of tuberculosis and other infections associated with etanercept, it should be discontinued immediately.

Effectiveness of a systematic vaccination program in patients with autoimmune inflammatory disease treated with anti-TNF alpha drugs.

OBJECTIVE: The objective of this is manuscript is to evaluate the impact of a vaccination protocol in the prevention of infection in autoimmune inflammatory disease (AUTID) patients treated with Anti-TNF-alpha therapies. RESEARCH DESIGN AND METHODS: The authors conducted an observational study to test the effect of a vaccination program in AUTID patients that received anti-TNF-alpha therapies in hospital admissions related to infections. This effect was evaluated by comparing patients admitted before the program started (prevaccination period, 2009-2011) and after the program (postvaccination period, 2011-2014). RESULTS: The study included 581 patients: 280 in the pre-vaccination group and 301 in the post-vaccination group. During the prevaccination period, 27.3% of patients treated with anti-TNF-alpha drugs were vaccinated before biological therapy. During the postvaccination period, this percentage increased to 97.0%. Statistically significant differences were detected in emergency room visits per 10.000 treatment days, in hospital admissions related to an infectious disease and in the rate of invasive pneumococcal disease due to Streptococcus pneumoniae infection per 10.000 days of treatment. CONCLUSIONS: This vaccination program decreases infectious complications and was associated with a lower amount of hospital admissions due to infections, emergency room visits and the rate of invasive pneumococcal disease.

Clinical and economic impact of the use of etanercept 25 mg once weekly in rheumatoid arthritis, psoriatic arthropathy and ankylosing spondylitis patients.

OBJECTIVE: To determine the clinical and economic impact of etanercept 25 mg/week (ETN25) on rheumatoid arthritis (RA), psoriatic arthropathy (PA) and ankylosing spondylitis (AS) patients in sustained clinical remission. METHODS: Observational, retrospective cohort of patients treated with etanercept 50 mg/week (ETN50) who achieved and maintained clinical remission (Disease Activity Score 28 < 2.6 or BASDAI < 2) over a period of 1 year and had slow worsening of structural changes were enrolled in an off-label program (January 2006 to June 2013) to switch from ETN50 to ETN25. Economic impact was assessed using Enbrel® official prices for Spain. RESULTS: From 1 January 2006 to 1 June 2013, 98 RA, 40 PA and 47 AS patients were treated with ETN50; 39 (24%) patients (20 women; age = 53 ± 7 years; 24 RA, 7 PA, 8 AS) received ETN25 for at least 0.5 years (2.6 ± 2.0 years; range = 0.5 - 7.3 years). As of 1 June 2013, 29 (74%) patients continued on ETN25. RA patients: 17 patients continued on ETN25, 5 patients discontinued use due to reactivation of RA (4 switched back to ETN50 and 1 switched to adalimumab; all regained clinical remission) and 2 patients discontinued use due to adverse reactions. PA patients: four patients continued on ETN25, two patients discontinued use due to reactivation of PA (switched back to ETN50, regaining clinical remission) and one patient discontinued use due to adverse reaction. All AS patients continued on ETN25. The total savings associated with ETN25 over the 7-year observation period were €622,073, resulting in the ability to treat 52 additional patients with ETN50 for one year without increasing total ETN costs. CONCLUSION: ETN25 produces cost savings while maintaining clinical response in a high proportion of patients after at least one year under clinical remission with ETN50. At a time when the cost of therapy is an unavoidable component of healthcare treatment decisions, ETN25 could be a cost-effective option for selective RA, PA and AS patients.

Educational session as a tool to increase patient satisfaction of switching etanercept from the prefilled syringe to the autoinjection pen.

OBJECTIVE: To assess patients' acceptability of switching etanercept from the prefilled syringe to the autoinjection pen in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis patients. METHODS: A two-phase cross-sectional study was designed. First phase: consisted of a 2 h information/education session to present the pen and learning its use. At the end of the session, patients completed a self-administered questionnaire regarding the meeting usefulness. Second phase: eight single-use prefilled Enbrel® Pen Myclic were provided. RESULTS: The number of patients included were 104 (rheumatoid arthritis 58, psoriatic arthritis 31, ankylosing spondylitis 15). Attendees showed a high satisfaction degree with the meeting. A high percentage of patients (74.4 - 95.1%) rated the items of the questionnaire as 'very much'. Patients reported > 95% adherence to etanercept autoinjection pen. The percentage of patients self-administering etanercept increased from 66 to 94% and the percentage of those attending primary care for injection decreased from 23 to 2%. It produced important cost savings, in our study represents > 22.000 euros/year. Pain at the injection site was significantly reduced with the use of autoinjection pen. Ninty seven (93%) patients considered that the use of the autoinjection pen was easier than the syringe and 94.2% chose the pen as their preferred delivery system. CONCLUSIONS: The autoinjection pen is an advantageous delivery option for etanercept. This study provides further evidence to support that the education strategy is a valid method for switching anti-TNF-α drugs from syringe to pen in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Acceptability of switching adalimumab from a prefilled syringe to an autoinjection pen.

OBJECTIVE: To assess patients' acceptance of switching adalimumab from a prefilled syringe to an autoinjection pen. METHODS: A two-phase cross-sectional study. The first phase consisted of a 2-h information/education session to present the pen and assist patients in learning its use. At the end of the session, patients completed a self-administered questionnaire regarding usefulness of the meeting. At the next hospital pharmacy dispensing visit the autoinjection pen was provided. Four single-use prefilled devices (40 mg/0.8 ml every other week) were provided. RESULTS: The study population included 55 patients (rheumatoid arthritis 29, psoriatic arthritis 17, ankylosing spondylitis 9). Attendees showed a high degree of satisfaction with the education session (between 72.7 and 90.9% rated the relevant items of the questionnaire in the highest category). Fifty-one patients participated in the second phase of the study. Patients reported 100% adherence to treatment with the autoinjection pen. The percentage of patients self-administering medication increased from 51 to 84% and the percentage attending primary care for injection decreased from 33 to 2%. Pain at the injection site was significantly reduced with the use of the autoinjection pen. The mean (sd) visual analogue scale (VAS) score was 3.52 (2.26) for the syringe compared with 2.02 (2.16) for the pen (p < 0.001). Forty-four (86.3%) patients considered that the use of the autoinjection pen was easier than the syringe, and 96.1% chose the pen as their preferred delivery system. CONCLUSIONS: This study provides further evidence to support the use of the autoinjection pen as a delivery option for adalimumab therapy.