Different risk profiles of biologic agents for new-onset psoriasis in patients with rheumatoid arthritis.

OBJECTIVE: To investigate rates and risk factors for incident and recurrent psoriasis in rheumatoid arthritis (RA) patients treated with different biologic (b) and conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs). METHODS: RA patients enrolled in the German biologics register RABBIT without (n = 14,525) or with a history of psoriasis (n = 375) were analyzed separately. All first events of psoriasis reported until October 2017 were assigned to the treatments prescribed in the previous 3 months. Crude incidence rates (IR) of psoriasis were calculated per 1000 patient-years. To investigate risk factors for psoriasis, cox regressions with and without inverse probability weights were applied to adjust for confounding by indication. RESULTS: 117 incident and 37 recurrent psoriatic events were reported. Patients exposed to TNFi had a significantly higher incidence rate (IR = 3.04/1,000 PY) than those exposed to csDMARDs only (IR = 0.65), whereas IRs for abatacept, rituximab and tocilizumab did not differ significantly from csDMARDs. Adjusted Cox regression confirmed a higher risk for TNFi. Female sex (HR: 1.7) and smoking (HR: 2.1) were significantly associated with incident psoriasis while methotrexate decreased the risk (HR: 0.5). For recurrent psoriasis, IRs for TNFi, abatacept and rituximab were significantly higher than for csDMARDs. CONCLUSIONS: Our data confirm a previously observed increased risk of incident psoriasis in patients exposed to TNFi compared to csDMARDs. However, the overall risk is low and the event is usually non-serious. Comedication of TNFi with methotrexate seems to lower the risk of incident psoriasis. In patients with a history of psoriasis, recurrence as adverse event is rare.

Evaluation of the RABBIT Risk Score for serious infections.

OBJECTIVE: To evaluate the Rheumatoid Arthritis Observation of Biologic Therapy (RABBIT) Risk Score for serious infections in patients with rheumatoid arthritis (RA). METHODS: The RABBIT Risk Score for serious infections was developed in 2011 on a cohort of RA patients enrolled in the German biologics register RABBIT between 2001 and 2007. To evaluate this score, we used data from patients enrolled in RABBIT after 1 January 2009. Expected numbers of serious infections and expected numbers of patients with at least one serious infection per year were calculated by means of the RABBIT Risk Score and compared with observed numbers in the evaluation sample. RESULTS: The evaluation of the score in an independent cohort of 1522 RA patients treated with tumour necrosis factor α (TNFα) inhibitors and 1468 patients treated with non-biological disease-modifying antirheumatic drugs (DMARDs) showed excellent agreement between observed and expected rates of serious infections. For patients exposed to TNF inhibitors, expected as well as observed numbers of serious infections were 3.0 per 100 patient-years (PY). For patients on non-biological DMARDs the expected and observed numbers were 1.5/100 PY and 1.8/100 PY, respectively. The score was highly predictive in groups of patients with low as well as with high infection risk. CONCLUSIONS: The RABBIT Risk Score is a reliable instrument which determines the risk of serious infection in individual patients based on clinical and treatment information. It helps the rheumatologist to balance benefits and risks of treatment, to avoid high-risk treatment combinations and thus to make informed clinical decisions.

[Effectiveness and limits of D-penicillamine therapy]. / Wirksamkeit und Grenzen der D-Penicillamintherapie.

A total of 232 patients with rheumatoid arthritis were treated with DPA. Withdrawal from treatment was mainly due to adverse events in the first year of treatment, while in the subsequent years it was mainly due to loss of efficacy. Of the patients treated, 68 were included in the present study, as they fulfilled the criteria of continuous long-term observation regularly performed. The effects of therapy were graded after 1 year of treatment, at the last examination in the outpatient department or before withdrawal, respectively. It could be seen that a long duration of the disease did not exclude positive effects of therapy; however, early use of DPA led to more favourable results with respect to the number of successfully treated patients and to the extent of the grading of efficacy. In patients who did not respond to DPA therapy, not only was the duration of the disease longer, but also previous therapy with other slow acting antirheumatic agents had been stopped because of inefficacy. This group of patients seems to cover therapy-resistant cases. After 1 year of treatment, improvement was measured in 54 patients. During further treatment, a tendency to return to initial values of clinical and laboratory parameters was noted. In about half the patients with only moderate improvement after 1 year, subsequent treatment was terminated (because of inefficacy) quite soon in most cases, i.e. within 5 years. Optimal improvement after 1 year, however, seems to indicate a long-term positive response to DPA therapy. In cases with no obvious effect of DPA after 1 year a response is not to be expected with ongoing treatment.(ABSTRACT TRUNCATED AT 250 WORDS)