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Meta-Analysis
. 2017 Jun 9;6(6):CD012095.
doi: 10.1002/14651858.CD012095.pub2.

Celecoxib for rheumatoid arthritis

Mahir Fidahic  1 , Antonia Jelicic Kadic, Mislav Radic, Livia Puljak
Affiliations
Meta-Analysis

Celecoxib for rheumatoid arthritis

Mahir Fidahic et al. Cochrane Database Syst Rev. .

Abstract

Background: Rheumatoid arthritis is a systemic auto-immune disorder that causes widespread and persistent inflammation of the synovial lining of joints and tendon sheaths. Presently, there is no cure for rheumatoid arthritis and treatment focuses on managing symptoms such as pain, stiffness and mobility, with the aim of achieving stable remission and improving mobility. Celecoxib is a selective non-steroidal anti-inflammatory drug (NSAID) used for treatment of people with rheumatoid arthritis.

Objectives: To assess the benefits and harms of celecoxib in people with rheumatoid arthritis.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and clinical trials registers (ClinicalTrials.gov and the World Health Organization trials portal) to May 18, 2017. We also searched the reference and citation lists of included studies.

Selection criteria: We included prospective randomized controlled trials (RCTs) that compared oral celecoxib (200 mg and 400 mg daily) versus no intervention, placebo or a traditional NSAID (tNSAID) in people with confirmed rheumatoid arthritis, of any age and either sex. We excluded studies with fewer than 50 participants in each arm or had durations of fewer than four weeks treatment.

Data collection and analysis: We used standard methodological procedures expected by The Cochrane Collaboration.

Main results: We included eight RCTs with durations of 4 to 24 weeks, published between 1998 and 2014 that involved a total of 3988 adults (mean age = 54 years), most of whom were women (73%). Participants had rheumatoid arthritis for an average of 9.2 years. All studies were assessed at high or unclear risk of bias in at least one domain. Overall, evidence was assessed as moderate-to-low quality. Five studies were funded by pharmaceutical companies. Celecoxib versus placeboWe included two studies (N = 873) in which participants received 200 mg daily or 400 mg daily or placebo. Participants who received celecoxib showed significant clinical improvement compared with those receiving placebo (15% absolute improvement; 95% CI 7% to 25%; RR 1.53, 95% CI 1.25 to 1.86; number needed to treat to benefit (NNTB) = 7, 95% CI 5 to 13; 2 studies, 873 participants; moderate to low quality evidence).Participants who received celecoxib reported less pain than placebo-treated people (11% absolute improvement; 95% CI 8% to 14%; NNTB = 4, 95% CI 3 to 6; 1 study, 706 participants) but results were inconclusive for improvement in physical function (MD -0.10, 95% CI 0.29 to 0.10; 1 study, 706 participants).In the celecoxib group, 15/293 participants developed ulcers, compared with 4/99 in the placebo group (Peto OR 1.26, 95% CI 0.44 to 3.63; 1 study, 392 participants; low quality evidence). Nine (of 475) participants in the celecoxib group developed short-term serious adverse events, compared with five (of 231) in the placebo group (Peto OR 0.87 (0.28 to 2.69; 1 study, 706 participants; low quality evidence).There were fewer withdrawals among people who received celecoxib (163/475) compared with placebo (130/231) (22% absolute change; 95% CI 16% to 27%; RR 0.61, 95% CI 0.52 to 0.72; 1 study, 706 participants).Cardiovascular events (myocardial infarction, stroke) were not reported. However, regulatory agencies warn of increased cardiovascular event risk associated with celecoxib. Celecoxib versus tNSAIDsSeven studies (N = 2930) compared celecoxib and tNSAIDs (amtolmetin guacyl, diclofenac, ibuprofen, meloxicam, nabumetone, naproxen, pelubiprofen); one study included comparisons of both placebo and tNSAIDs (N = 1149).There was a small improvement, which may not be clinically significant, in numbers of participants achieving ACR20 criteria response in the celecoxib group compared to tNSAIDs (4% absolute improvement; 95% CI 0% less improvement to 8% more improvement; RR 1.10, 95% CI 0.99 to 1.23; 4 studies, 1981 participants). There was a lack of evidence of difference between participants in the celecoxib and tNSAID groups in terms of pain or physical function. Results were assessed at moderate-to-low quality evidence (downgraded due to risk of bias and inconsistency).People who received celecoxib had a lower incidence of gastroduodenal ulcers ≥ 3 mm (34/870) compared with those who received tNSAIDs (116/698). This corresponded to 12% absolute change (95% CI 11% to 13%; RR 0.22, 95% CI 0.15 to 0.32; 5 studies, 1568 participants; moderate quality evidence). There were 7% fewer withdrawals among people who received celecoxib (95% CI 4% to 9%; RR 0.73, 95% CI 0.62 to 0.86; 6 studies, 2639 participants).Results were inconclusive for short-term serious adverse events and cardiovascular events (low quality evidence). There were 17/918 serious adverse events in people taking celecoxib compared to 42/1236 among people who received placebo (Peto OR 0.71; 95% CI 0.39 to 1.28; 5 studies, 2154 participants). Cardiovascular events were reported in both celecoxib and placebo groups in one study (149 participants).

Authors' conclusions: Celecoxib may improve clinical symptoms, alleviate pain and contribute to little or no difference in physical function compared with placebo. Celecoxib was associated with fewer numbers of participant withdrawals. Results for incidence of gastroduodenal ulcers (≥ 3 mm) and short-term serious adverse events were uncertain; however, there were few reported events for either.Celecoxib may slightly improve clinical symptoms compared with tNSAIDs. Results for reduced pain and improved physical function were uncertain. Particpants taking celecoxib had lower incidence of gastroduodenal ulcers (≥ 3 mm) and there were fewer withdrawals from trials. Results for cardiovascular events and short-term serious adverse events were also uncertain.Uncertainty about the rate of cardiovascular events between celecoxib and tNSAIDs could be due to risk of bias; another factor is that these were small, short-term trials. It has been reported previously that both celecoxib and tNSAIDs increase cardiovascular event rates. Our confidence in results about harms is therefore low. Larger head-to-head clinical trials comparing celecoxib to other tNSAIDs is needed to better inform clinical practice.

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Conflict of interest statement

Mahir Fidahic: no conflict of interest. Antonia Jelicic Kadic: no conflict of interest. Mislav Radic: no conflict of interest. Livia Puljak: no conflict of interest.

Figures

1
1
Study flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
1.1
1.1. Analysis
Comparison 1 Celecoxib versus placebo, Outcome 1 ACR20.
1.2
1.2. Analysis
Comparison 1 Celecoxib versus placebo, Outcome 2 Pain (VAS).
1.3
1.3. Analysis
Comparison 1 Celecoxib versus placebo, Outcome 3 HAQ.
1.4
1.4. Analysis
Comparison 1 Celecoxib versus placebo, Outcome 4 Incidence of gastroduodenal ulcers ≥ 3 mm.
1.5
1.5. Analysis
Comparison 1 Celecoxib versus placebo, Outcome 5 Short term serious adverse events.
1.6
1.6. Analysis
Comparison 1 Celecoxib versus placebo, Outcome 6 Total withdrawals (discontinuation rates).
1.7
1.7. Analysis
Comparison 1 Celecoxib versus placebo, Outcome 7 Withdrawals due to adverse events.
1.8
1.8. Analysis
Comparison 1 Celecoxib versus placebo, Outcome 8 Withdrawals due to lack of efficacy.
2.1
2.1. Analysis
Comparison 2 Celecoxib versus NSAIDs, Outcome 1 ACR20.
2.2
2.2. Analysis
Comparison 2 Celecoxib versus NSAIDs, Outcome 2 Pain (VAS).
2.3
2.3. Analysis
Comparison 2 Celecoxib versus NSAIDs, Outcome 3 HAQ.
2.4
2.4. Analysis
Comparison 2 Celecoxib versus NSAIDs, Outcome 4 MHAQ.
2.5
2.5. Analysis
Comparison 2 Celecoxib versus NSAIDs, Outcome 5 Cardiovascular events (myocardial infarction, stroke).
2.6
2.6. Analysis
Comparison 2 Celecoxib versus NSAIDs, Outcome 6 Incidence of gastroduodenal ulcers ≥ 3 mm.
2.7
2.7. Analysis
Comparison 2 Celecoxib versus NSAIDs, Outcome 7 Short‐term serious adverse events.
2.8
2.8. Analysis
Comparison 2 Celecoxib versus NSAIDs, Outcome 8 Total withdrawals (discontinuation rates).
2.9
2.9. Analysis
Comparison 2 Celecoxib versus NSAIDs, Outcome 9 Withdrawals due to adverse events.
2.10
2.10. Analysis
Comparison 2 Celecoxib versus NSAIDs, Outcome 10 Withdrawals due to lack of efficacy.
3.1
3.1. Analysis
Comparison 3 Celecoxib versus naproxen, Outcome 1 ACR20.
3.2
3.2. Analysis
Comparison 3 Celecoxib versus naproxen, Outcome 2 Pain (VAS).
3.3
3.3. Analysis
Comparison 3 Celecoxib versus naproxen, Outcome 3 HAQ.
3.4
3.4. Analysis
Comparison 3 Celecoxib versus naproxen, Outcome 4 Incidence of gastroduodenal ulcers ≥ 3 mm.
3.5
3.5. Analysis
Comparison 3 Celecoxib versus naproxen, Outcome 5 Short‐term serious adverse events.
3.6
3.6. Analysis
Comparison 3 Celecoxib versus naproxen, Outcome 6 Total withdrawals (discontinuation rates).
3.7
3.7. Analysis
Comparison 3 Celecoxib versus naproxen, Outcome 7 Withdrawals due to adverse events.
3.8
3.8. Analysis
Comparison 3 Celecoxib versus naproxen, Outcome 8 Withdrawals due to lack of efficacy.
4.1
4.1. Analysis
Comparison 4 Celecoxib versus diclofenac, Outcome 1 ACR20.
4.2
4.2. Analysis
Comparison 4 Celecoxib versus diclofenac, Outcome 2 Pain (VAS).
4.3
4.3. Analysis
Comparison 4 Celecoxib versus diclofenac, Outcome 3 MHAQ.
4.4
4.4. Analysis
Comparison 4 Celecoxib versus diclofenac, Outcome 4 Incidence of gastroduodenal ulcers ≥ 3 mm.
4.5
4.5. Analysis
Comparison 4 Celecoxib versus diclofenac, Outcome 5 Short‐term serious adverse events.
4.6
4.6. Analysis
Comparison 4 Celecoxib versus diclofenac, Outcome 6 Total withdrawals (discontinuation rates).
4.7
4.7. Analysis
Comparison 4 Celecoxib versus diclofenac, Outcome 7 Withdrawals due to adverse events.
4.8
4.8. Analysis
Comparison 4 Celecoxib versus diclofenac, Outcome 8 Withdrawals due to lack of efficacy.
5.1
5.1. Analysis
Comparison 5 Celecoxib versus meloxicam, Outcome 1 ACR20.
5.2
5.2. Analysis
Comparison 5 Celecoxib versus meloxicam, Outcome 2 Short‐term serious adverse events.
5.3
5.3. Analysis
Comparison 5 Celecoxib versus meloxicam, Outcome 3 Total withdrawals (discontinuation rates).
5.4
5.4. Analysis
Comparison 5 Celecoxib versus meloxicam, Outcome 4 Withdrawals due to adverse events.
5.5
5.5. Analysis
Comparison 5 Celecoxib versus meloxicam, Outcome 5 Withdrawals due to lack of efficacy.
6.1
6.1. Analysis
Comparison 6 Celecoxib versus nabumetone, Outcome 1 ACR20.
6.2
6.2. Analysis
Comparison 6 Celecoxib versus nabumetone, Outcome 2 Short term serious adverse events.
6.3
6.3. Analysis
Comparison 6 Celecoxib versus nabumetone, Outcome 3 Total withdrawals (discontinuation rates).
6.4
6.4. Analysis
Comparison 6 Celecoxib versus nabumetone, Outcome 4 Withdrawals due to adverse events.
6.5
6.5. Analysis
Comparison 6 Celecoxib versus nabumetone, Outcome 5 Withdrawals due to lack of efficacy.
7.1
7.1. Analysis
Comparison 7 Celecoxib versus amtolmetin guacyl, Outcome 1 ACR20.
7.2
7.2. Analysis
Comparison 7 Celecoxib versus amtolmetin guacyl, Outcome 2 Incidence of gastroduodenal ulcers ≥ 3 mm.
7.3
7.3. Analysis
Comparison 7 Celecoxib versus amtolmetin guacyl, Outcome 3 Short‐term serious adverse events.
7.4
7.4. Analysis
Comparison 7 Celecoxib versus amtolmetin guacyl, Outcome 4 Total withdrawals (discontinuation rates).
7.5
7.5. Analysis
Comparison 7 Celecoxib versus amtolmetin guacyl, Outcome 5 Withdrawals due to adverse events.
8.1
8.1. Analysis
Comparison 8 Celecoxib versus pelubiprofen, Outcome 1 Pain (VAS).
8.2
8.2. Analysis
Comparison 8 Celecoxib versus pelubiprofen, Outcome 2 HAQ.
8.3
8.3. Analysis
Comparison 8 Celecoxib versus pelubiprofen, Outcome 3 Cardiovascular events (myocardial infarction, stroke).
8.4
8.4. Analysis
Comparison 8 Celecoxib versus pelubiprofen, Outcome 4 Short‐term serious adverse events.
8.5
8.5. Analysis
Comparison 8 Celecoxib versus pelubiprofen, Outcome 5 Total withdrawals (discontinuation rates).
8.6
8.6. Analysis
Comparison 8 Celecoxib versus pelubiprofen, Outcome 6 Withdrawals due to adverse events.
9.1
9.1. Analysis
Comparison 9 Celecoxib versus ibuprofen, Outcome 1 Incidence of gastroduodenal ulcers ≥ 3 mm.
9.2
9.2. Analysis
Comparison 9 Celecoxib versus ibuprofen, Outcome 2 Short‐term serious adverse events.
9.3
9.3. Analysis
Comparison 9 Celecoxib versus ibuprofen, Outcome 3 Total withdrawals (discontinuation rates).
9.4
9.4. Analysis
Comparison 9 Celecoxib versus ibuprofen, Outcome 4 Withdrawals due to adverse events.
9.5
9.5. Analysis
Comparison 9 Celecoxib versus ibuprofen, Outcome 5 Withdrawals due to lack of efficacy.
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