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Objectives: To compare the effectiveness of a 2nd TNF inhibitor (TNFi), Tocilizumab (TCZ) and Rituximab (RTX), measured by drug retention and by response rates, in RA patients after discontinuing a first-line TNFi and to clarify the reasons and predictors for discontinuation of a second-line biologic. Material and Methods: Non-interventional prospective study of RA patients exposed to a 2nd TNFi, TCZ or RTX after previous TNFi discontinuation using real-world data from Reuma.pt database. Drug retention was estimated using Kaplan-Meier analysis and Cox models. Crude and LUNDEX adjusted response rates were evaluated at 6 months, 1 and 2 years and reasons for discontinuation were compared according to biologic class. Results: In total, 643 patients were included, 88.8% females, with a mean age of 59.4±12.8 years. Of those, 390 (60.7%) initiated a 2nd TNFi, 147 (22.9%) TCZ and 106 (16.5%) RTX. Drug retention was significantly greater among patients who initiated TCZ (76.4±4.3 months) or RTX (80.8±4.8 months), compared with those who initiated a 2nd TNFi (52.7±2.6 months) (log rank test, p < 0.001). In the adjusted Cox model, hazards of discontinuation were significantly lower for TCZ (HR 0.39, 95% CI 0.23-0.64, p < 0.001) and RTX (HR 0.42, 95% CI 0.25-0.72, p=0.001). Smokers had a significantly higher risk for discontinuation (HR 2.43, 95%CI 1.50-3.95, p < 0.001) as well as patients with higher HAQ at baseline (HR 1.51, 95%CI 1.14-2.00, p=0.004). The proportion of patients in remission or low disease activity according to Clinical Disease Activity Index (CDAI) at 6 months, 1 and 2 years was, respectively, 46.5%/50.0%/61.2% for TNFi, 52.9%/53.6%/ 69.2% for TCZ and 37.7%/48.0%/50.0% for RTX. After LUNDEX adjustment, response rates were, respectively, 33.0%/31.0%/31.8% for 2nd TNFi, 42.8%/41.8%/53.3% for TCZ and 32.0%/39.4%/39.0% for RTX. The main reasons for discontinuation were inefficacy for 2nd TNFi and RTX and adverse events for TCZ (p < 0.001). Conclusions: Our findings showed a significantly higher drug retention for TCZ and RTX, compared with 2nd TNFi, and similar persistence among TCZ and RTX, in patients who discontinued a first-line TNFi. These data corroborate the notion that switching to a biologic with a different mode of action is more effective than to a second TNFi.

Background: Advances in osteoporosis (OP)case definition, treatment options, optimal therapy duration and pharmacoeconomic evidence in the national context motivated the Portuguese Society of Rheumatology (SPR) to update the Portuguese recommendations for the diagnosis and management of osteoporosis published in 2007. Methods: SPR bone diseases’ working group organized meetings involving 55 participants (rheumatologists, rheumatology fellows and one OP specialist nurse) to debate and develop the document. First, the working group selected 11 pertinent clinical questions for the diagnosis and management of osteoporosis in standard clinical practice. Then, each question was investigated through literature review and draft recommendations were built through consensus. When insufficient evidence was available, recommendations were based on experts’ opinion and on good clinical practice. At two national meetings, the recommendations were discussed and updated. A draft of the recommendations full text was submitted to critical review among the working group and suggestions were incorporated. A final version was circulated among all Portuguese rheumatologists before publication and the level of agreement was anonymously assessed using an online survey. Results: The 2018 SPR recommendations provide comprehensive guidance on osteoporosis prevention, diagnosis, fracture risk assessment, pharmacological treatment initiation, therapy options and duration of treatment, based on the best available evidence. They attained desirable agreement among Portuguese rheumatologists. As more evidence becomes available, periodic revisions will be performed. Target audience and patient population: The target audience for these guidelines includes all clinicians. The target patient population includes adult Portuguese people. Intended use: These recommendations provide general guidance for typical cases. They may not be appropriate in all situations - clinicians are encouraged to consider this information together with updated evidence and their best clinical judgment in individual cases.

Background: Switching between biologic therapies is a recommended strategy for Psoriatic Arthritis (PsA) patients that show an insufficient response or adverse events. Although the choice of the subsequent biologic may be dependent on many factors, assessing the quality of the switch decision is of utmost relevance. Objectives: To develop and validate two outcomes measurement tools (for patients with peripheral and axial PsA phenotypes) that address the quality of treatment decisions in PsA regarding the switch of biologic therapies in clinical practice. Methods: A Task Force and an Expert Panel were specifically assembled for this purpose. The Psoriatic Arthritis Switch Quality Assessment tool (PASQAL) de-velopment comprised a modified-Delphi method in a four-step procedure: 1) literature search and experts' opinion collection about quality indicators for PsA management; 2) Delphi design to address the development of the measurement tool; 3) three Delphi questionnaire rounds; 4) final consensus meeting. This phase resulted in the definition of two measurement tools, one to evaluate the quality of biologic switch in peripheral (pPASQAL) and another one in axial PsA (axPASQAL). For the validation of PASQAL, 12 experienced rheumatologists were asked to evaluate and classify the biologic switch of 80 clinical cases (40 with predominant peripheral and 40 with predominant axial PsA). Clinical judgement was defined to be the "gold standard" against which the performance of PASQAL was assessed. The results were used to assess tools' performance (sensitivity/specificity analysis) and the agreement between the tools and the gold standard (Cohen's kappa). Results: PASQAL consists of 6 domains (joint disease activity, dactylitis, enthesis, physical function, quality of life, and skin and nail manifestations), respective instruments and thresholds. The classification of the biologic switch was divided into three quality levels: "Good", based on treat-to-target thresholds; "Mode-rate", based on improvement from baseline; and the remaining as "Insufficient". pPASQAL was found to be highly sensitive (92%) with the "Good" quality level and specific (97%) with the "Insufficient" quality le vel. Whilst axPASQAL showed overall higher sensitivity and specificity for all quality levels, as well as a higher level of agreement between the tool and the gold standard than pPASQAL (k=0.87 vs k=0.71). Conclusion: PASQAL was developed and showed good criterion validity for the evaluation of the quality of switch in both peripheral and axial PsA phenotypes. These tools may be used in research as well as in clinical practice, to support rheumatologists in making more informed therapeutic decisions. publishersversion published

Objective: To update the recommendations for the treatment of axial spondyloarthritis (axSpA) with biological therapies, endorsed by the Portuguese Society of Rheumatology. Methods: These treatment recommendations were formulated by Portuguese rheumatologists based on lite - rature evidence and consensus opinion. At a national meeting, the recommendations included in this document were discussed and updated. A draft of the full text of the recommendations was then circulated and suggestions were incorporated. A final version was again circulated before publication and the level of agreement among Portuguese Rheumatologists was anonymously assessed using an online survey. Results: A consensus was achieved regarding the initiation, assessment of response and switching of biological therapies in patients with axSpA. In total, seven recommendations were produced. The first recommendation is a general statement indicating that biological therapy is not a first-line drug treatment option and should only be used after conventional treatment has failed. The second recommendation is also a ge - neral statement about the broad concept of axSpA adopted by these recommendations that includes both non-radiographic and radiographic axSpA. Recommendations 3 to 7 deal with the definition of active di - sease (including the recommended threshold of 2.1 for the Ankylosing Spondylitis Disease Activity Score [ASDAS] or the threshold of 4 [0-10 scale] for the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]), conventional treatment failure (nonsteroidal anti-inflammatory drugs being the first-line drug treatment), assessment of response to treatment (based on an ASDAS improvement of at least 1.1 units or a BASDAI improvement of at least 2 units [0-10 scale] or at least 50%), and strategy in the presence of an ina - dequate response (where switching is recommended) or in the presence of long-term remission (where a process of biological therapy optimization can be consi - dered, either a gradual increase in the interval between doses or a decrease of each dose of the biological the - rapy). Conclusion: These recommendations may be used for guidance in deciding which patients with axSpA should be treated with biological therapies. They co - ver a rapidly evolving area of therapeutic intervention. As more evidence becomes available and more biological therapies are licensed, these recommendations will have to be updated. publishersversion published