[Anakinra, a recombinant human IL-1 receptor antagonist, in clinical practice. Outcome in 60 patients with severe rheumatoid arthritis]. / Anakinra, antagonista umano ricombinante del recettore dell'IL-1, nella pratica clinica. Outcome in 60 pazienti con artrite reumatoide severa.

OBJECTIVE: We evaluated both the efficacy and safety of anakinra in daily routine rheumatoid arthritis clinical practice. METHODS: We studied 60 cases, including patients with previous anti-TNFalpha exposure, treated with anakinra (100 mg/daily s.c.) in combination with methotrexate (7.5-10 mg/week i.m.) or leflunomide (20 mg/die) in a two year observational study. Efficacy measures were assessed using the American College of Rheumatology (ACR) response criteria. Safety was evaluated according to a modified World Health Organization adverse reaction term dictionary. RESULTS: At week 14, ACR 20% response criteria have been fulfilled by 53 (91.3%) out of 58 patients, 51 (87.9%) of them achieving also an ACR 50%and 15 (25.8%) an ACR 70%response. Thirteen patients touched 102 weeks of treatment: ACR 20% response was achieved in 92.3%, while ACR 50% and ACR 70% were respectively found in 84.6% and 38.4% of the cases. The mean decrease in HAQ score was 0.38, p<0.001. Of the 16 patients who were previously treated with anti-TNFalpha blockers, 81.2% responded to anakinra. There was no significant difference in the ACR response between groups with and without previous anti-TNFalpha exposure. Seventeen patients (28.3%) stopped anakinra because of side-effects (5%) or failure to respond (23.3%). Only 4 cases of pulmonitis, of which 2 have been hospitalised, and 1 case with tuberculosis (previously treated with infliximab) were observed. CONCLUSIONS: Our clinical experience confirms that anakinra is effective and safe in the treatment of rheumatoid arthritis. Anakinra seems also useful in patients with previous anti-TNFalpha blockers failures. Even though major adverse events were rare, clinicians should be aware of such a possibility.

Clinical evaluation of hexagonal keratotomy for the treatment of primary hyperopia.

We evaluated the effectiveness of spiral hexagonal keratotomy in correcting primary hyperopia in 199 eyes. One hundred eighty-four eyes (92.5%) had a minimum follow-up of three months. Mean follow-up was 11.9 months and maximum, 36.2 months. Secondary astigmatic keratotomy was performed on 54 eyes six to eight months after initial hexagonal surgery to correct induced astigmatism. The mean reduction in spherical equivalent was -1.6 +/- 0.9 diopters (D) (range -5.6 to +0.9 D). The mean increase in refractive cylinder was +0.5 +/- 0.9 D (range -2.3 to +3.0 D). Uncorrected acuity improved by +3.2 lines, while best corrected acuity decreased slightly by -0.26 lines. Loss of two or more lines of best corrected acuity that was attributable to surgery was between 0.5% and 4.0%.