Background Symptomatic therapy of rheumatoid arthritis (RA) such as non-steroidal anti-inflammatory medications (NSAIDs) can be accompanied by serious side effects.
Objectives to assess anti-inflammatory, analgesic, immunomodulatory action and tolerability of Incena as an addition to standard therapy in patients (pts) with active RA.
Methods 50 pts with RA were studied with mean age 53.0±2.60 years (yrs), disease duration – 8.3±1.75 yrs. 86.0% of the pts were women; 68.0% - positive for RF and/or anti-CCP. The moderate RA activity was in 31 pts (62%), the low - in 19 (38%). 42 (84%) pts were treated with disease-modifying anti-rheumatic drugs for at least 3 months: methotrexate – 29 pts, sulfasalazine - 6, hydroxychloroquine – 4, combination of these drugs - 3. Glucocorticoids in a permanent dose (3.75-12.5 mg/d of prednisolone) for at least 2 months were received by 22 (44%) pts, NSAIDs for at least 1 month - 43 (86%) pts.
Pts were randomly assigned to either the treatment (25 pts) or the control (25 pts) groups. Pts of the treatment group were treated with the drug Incena (“Richard Bittner GmbH”, Austria) in dose 10 drops 3 times a day 30 minutes before meals while pts in the control group received placebo in the same dosage for 12 weeks.
There were not significant differences between groups by all parameters. Effectiveness outcomes were evaluated after 28±3 and 84±3 days by ACR20, 50, 70 criteria, dynamics (the average difference between the variants) of DAS28, mHAQ-DI, ESR, CRP, TNF-α and IL-10 (ELISA) levels in the serum.
Results The study was completed by 21 pts from placebo group and 22 pts from Incena group. In placebo group the clinical, laboratory parameters, DAS28 didn't have significant changes, although there was a trend toward the positive dynamics of the morning stiffness duration, number of swollen joints, patient's (PGA) and physician's disease global assessments (PhGA) on VAS.
In Incena group there was decrease in the morning stiffness duration (after 28 days - 47.8%, p<0.05; after 84 days - 41.7%, p>0.05), joint pain intensity (respectively by 28.5%, p<0.05 and 22.3%, p>0.05), improvement in PGA (by 28.7%, p<0.05 and 23.7%, p>0.05) and PhGA (23.7%, p<0.05 and 28.6%, p>0.05), decrease in DAS28 (18.2%, p<0.01 and 20.7%, p<0.05). mHAQ-DI at the 2nd visit was lower vs baseline by 32.1% (p<0.05), at the 3nd visit - by 41% (p<0.01) and lower vs placebo by 32.7% (p<0.05).
After 28 days by ACR20 responded 45.4% of pts in Incena group (in placebo - 12%, χ2=4.98, p<0.05), by ACR50 – 4.5% (placebo - 0%, p>0.05); after 84 days – respectively 36.4% (placebo -19%, p>0.05) and 18.2% (placebo - 0%, p>0.05). ACR70 criterion was reached at the final visit by one pt in each group.
By the end of the treatment period, ESR values were significantly lower vs baseline (by 31.5%, p<0.05) and vs placebo (31.2%, p<0.05). There weren't significant changes in CRP, TNF-α and IL-10 blood levels in both groups.
Tolerability of Incena and placebo was similar by clinical and laboratory data.
Conclusions Incena treatment in addition to stable standard therapy in RA pts with low or moderate disease activity, unlike placebo, provides valid analgesic and anti-inflammatory effect on articular status and laboratory data (decrease in ESR). Such treatment may be considered as an additive symptomatic therapy with good tolerability.
Disclosure of Interest None declared